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- Performs engineering work in operations, production, construction or maintenance environments. - Responsibilities are within the Engineering Family as a generalist or in a combination of disciplines. - Understands the roles and workflows of the Engineering and Maintenance functions. Devise and coordinate working relationships between the area and other areas, including other Sites - Establish the organizational structures of the area, anticipating or adapting to changing environment - Contribute to the construction and review of the company strategy by adding his/her experience and technical knowledge to enrich such strategy - Ensure all TMs are aligned and motivated towards achieving Hovione's goals, values and culture by promoting their personal and professional development whilst maximizing productivity. - Appraise team performance, coaching team members to elevate their performance through development plans and address poor performance through improvement plans together with HR business partner. - Identify and develop talent to guarantee future performance and area growth Ensure that team members assigned to area are trained in the required technical and behavioral competencies - Identify and promote systems and procedures that will benefit the global organization - Develop and propose for approval the, annual budget and budget plan in line with the corporate strategy, in order to align activities with Hovione strategic objectives - Define strategies and standards, aiming for CAPEX and OPEX optimization and knowledge management, to enable productivity, quality, cost competitiveness and safety. - Guarantee technical solutions for challenges during the life cycle of installations without compromising the design purpose and the process functionality, quality and safety - Select reliable and competent partner companies capable to support the life cycle of our facilities and equipment and our growth plans. - Ensure that continuous improvement and lean thinking is used in all departmental activities Liaise with authorities to guarantee timely approvals of submissions, ensuring that facilities are design and operate within Regulatory, Nationals laws and Health authority requirements. - Prepare and propose the annual area’s budget, by defining the allocation of resources necessary for the development of the activity, as well as ensuring the monitoring and control of its evolution, identifying any deviations between the real and the foreseen and taking corrective measures - Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice. - Ensure compliance with GMP, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others) within his/ her TMs.

Key roles for this person would be to help with more operational aspects: - Update media toolkits and media database for trade publications, liaise for booking of advertising, material availability etc - Identify and liaise with trade fairs/suppliers for implementation of booths, preparation of contracts - Scheduling of photo sessions and filming for campaigns - Identification of short list of suppliers - Preparation of sales materials for trade fairs, along with feedback collection via surveys and respective analysis

Promote one single source of truth, data highly reliable and up to date, best in class tools and practices to enhance productivity and the ability to manage costs. Facilitate cross-functional Sales and Operations Planning (S&OP, mid-term horizon) and Execution (short-term horizon) processes to create tensions and deliver best compromises in terms of supply response to demand forecast. Establish plans with appropriate granularity and firmness depending on horizons (mid, short-term horizons and execution), providing supply scenarios to demand, considering production and support areas capability and the best efficiency of resources' usage (people, equipment and materials), based on demonstrated performance.   - Create shift detailed schedule (30) / weekly plan (H90 & H700) for the whole portfolio to answer demand, having into account production and support areas constraints - Review and analyze the allocated resources (human resources, materials and/or processes) to comply with plan - Anticipate and monitor potential scheduling/planning and data management challenges, taking actions to mitigate risks; troubleshoots scheduling /planning / data problems; facilitates and actively contributes to H700H90 and H90H30 meetings; communicate and align alternative scenarios with other areas as defined in Planning and Data policies - Optimize the plan, ensuring the existence of resources for the continuous production and maximizing efficiency - Work in collaboration with Operational Excellence to drive consistency of recipes activities sequencing, standards/load factors definition and update; - Monitor performance and apply action plans to improve result of KPI's related to Planning/Scheduling process, mainly: Plan Adherence, Campaign Lead Time Adherence, Batch Execution Adherence, Batch Finish Date Adherence, Shift Performance, BOM accuracy, Routing accuracy, Work Location accuracy, Master Data and Supporting Accuracy - Create periodically reports detailing the status of critical activities of on-going projects and KPIs - Promote one single source of truth, data highly reliable and up to date, best in class tools and practices - Ensure all assigned tasks are properly planned and delivered on time, safely, efficiently, reliably and in a cost-effective manner - Propose improvements to the area as appropriate and solve problems - Make quality and timely decisions within the operations planning and data management tasks under her / his responsibility - Gather relevant data to inform the decision makers regarding complex issues - Collaborate in the investigation of events and propose corrective actions/preventive actions for deviations - Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice. - Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others)

Implements and manages the required guidelines and cGMPs for Hovione, providing LEAN based Quality Systems and Tools, controlled, harmonized and aligned with the company’s strategic plan, promoting a rigorous and continuous improvement culture to guarantee high quality compliant sites. Maintains active and efficient communication channels along the several Hovione sites, identifying Quality needs and improvements both from internal and external stakeholders. Evaluates, advises and provides services and technical support, internally and externally, related to the legal and scientific regulatory requirements in relation to product development, commercialization and optimization across the full product lifecycle to ensure compliance with both global and local regulatory legislation, guidelines, inspections, audits and other regulatory due diligence. Represents Hovione through communications and negotiations with regulatory authorities, preparing, submitting and managing all matters related to regulatory submissions and licensing for Hovione and customer products; and within professional associations, industry/trade groups.   - Promote high-quality work within the team and a mindset of continuous improvement - Advise Team Members when unconformities with Quality or, Regulatory Systems and Tools have been identified and promote corrective actions - Propose new procedures and or policies according to the requirements applicable to the company business and strategy and review existing procedures - Prepare Quality and/or Regulatory Systems and Tools related documentation and training - Participate in Audits/inspections (Internal and of Health Authorities) - Perform other Corporate key activities, such as delivering Corporate Quality or Regulatory KPI’s, Corporate Quality or Regulatory Training, Quality and/or Regulatory Systems Management (e.g., Documentation Management System), CAPA, Change Control, corporate analytical electronic systems, filings, customer support etc.) - Ensure all assigned tasks are planned and delivered on time, safely, efficiently, reliably and in a cost-effective manner - Propose improvements to the area as appropriate and solve problems - Lead initiatives within group or department, ensuring plan definition and timely execution - Make quality and timely decisions within the Quality and/or Regulatory Systems’ tasks under her / his responsibility - Gather relevant data to inform the decision makers regarding complex issues - Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice. - Execute professional activities in compliance with applicable Quality, Regulatory and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others) May qualify as internal GMP auditor

Guarantees cGMP compliance in all activities and systems related to Projects and Products execution. Assures that working practices are streamlined and aligned with the actual needs of each project. Implements policies, procedures and methods to evaluate and to continuously improve the quality of products and operations throughout the products lifecycle. Provides global supplier qualification services in support of new product introduction and existing products. Collaborates with suppliers and Procurement to assure the quality of their products, materials, components and/or operations.   - Rigorously, accurately, efficiently and professionally manage all quality activities for the assigned projects and / or products in accordance with applicable cGMP, quality operational standards / procedures and legal regulations, ensuring the site is always “audit ready” - Promote the importance of high-quality levels and the importance of a continuous improvement culture in relevant company activities - Act as a catalyst for change and improvement in performance/quality - Assigned projects may relate to any of the following (non-exhaustive) areas: Raw Materials, Suppliers, Specifications, Production Processes, Change Control, Deviations, Quality agreements, Qualification and Validation, Stability Programs, Batch Release, Equipment Cleaning, Client Audits, Internal Audits, Customer Complaints, Customer requirements, PQR - Provide an example of professionalism and support the induction and training of new colleagues within the area - Efficiently, accurately and reliably ensure that project and / or product activities are delivered in compliance with cGMP requirements and maintenance of the company Quality Management System is assured - Manage and participate in Quality Product key activities for the assigned product / projects, and introduction of new products; including (but not limited to) preparation, review and approval of auxiliary documentation, protocols and quality related reports - To prepare for and support internal and external site audits and inspections, conducting regular reviews and periodically following-up action plans as necessary. - Ensure inspection readiness in work completed and Act in an advisory capacity for all internal and external site audits - Periodic follow-up of ongoing deviations and PdAs to assure timely closure of deviations and approval of PdAs, as appropriate - To close open deviations and propose CAPAs based on the outcome of periodic follow-ups - Prepares SOPs, department IOPs, quality related reports, revision of executed batch documentation and change control documents (PdAs) as required and appropriate - Approves IOPs, process master documentation and product specifications as required and appropriate. - Ensures that SOPs and IOPs are up to date, compliant and supports efficient production - Review regulatory documentation and co-ordination of site documentation to support regulatory requirements - Authorize the usage of production equipment/utilities when qualification required - Solve challenges related to compliance problems by providing collaborative and timely support to all areas and departments, escalating as required - Ensure the effective and proactive flow of information between stakeholders, representing the team as appropriate - To assure and promote compliance on Health, Safety and Environment in the area and activities for which is responsible, or in which participates - To maintain a regular presence on manufacturing floor, providing on-the-job support, developing a sense of collaboration with operational areas and performing a general oversight of activities, as required - To approve Validation Master Plans, Process Validation Protocols and reports as required - Accurately use and maintain all information systems - Support the generation / reporting of KPIs for the team. - Develop and accumulate strong QA expertise, sharing knowledge of new developments and methodologies within the area - Co-ordinate and assist with the analysis and investigation of customer complaints that may arise; ensuring all complaints are investigated and closed out within specified timeframes - To provide relevant training to new colleagues, and to the other areas in applicable cGMP, internal procedures and quality systems in accordance with established training plans - Be an advocate for safe operating and high-quality performance, alerting ascending colleagues to any potential risks, discrepancies, deviations or non-conformance in accordance with Hovione internal procedures, suggesting optimizations or improvements - Ensure all assigned tasks are planned and delivered on time, safely, efficiently, reliably and in a cost-effective manner - Propose improvements to the area as appropriate and solve problems - Make quality and timely decisions within the Quality Assurance tasks under her / his responsibility - Gather relevant data to inform the decision makers regarding complex issues - Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others) - Undertake any additional tasks commensurate with the role as and when required. - Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.

- Perform maintenance on equipment and systems (e.g., mechanical, electrical); - Evaluate and recommends equipment improvements to increase reliability, capability and yield; - Perform equipment condition analysis (during preventive and unscheduled maintenance); - Prepare technical reports to document equipment modifications and equipment maintenance procedures; - Participate in the day to day preventative and corrective tasks (mechanical / electrical / instrumentation) in-line with the planned asset lifecycle management instructions; - Maintain, service, repair and troubleshoot all equipment and installations (mechanical / electrical / instrumentation) on site as per Standard Operating; - Ensure that equipment and infrastructures are maintained within their safe design operating limits, and in a way that avoids danger to personnel or the public; - Participate in the implementation of continuous improvement initiative and lean tools within the area (TOP meetings, TPM, 5S, SMED, 8D); - Participate in the Quality Assurance and HSE programs, guaranteeing the timely implementation of corrective actions (CAPA); - Undertake any additional tasks commensurate with the role as and when required.

Defines and implements quality control techniques in order to verify the quality of raw materials, intermediate and end products as well as any other analytical services relevant to our client base and according to regulatory requirements. Manage and control all Quality Control activities in accordance with identified quality assurance standards, company procedures, client specifications, contract requirements, and regulatory guidelines.   - Know all the HSEE procedures necessary to perform their functions in the workplaces of the area - Know all the quality procedures applicable to the performance of their duties - Support Hovione to achieve positive levels of customer satisfaction and quality compliance by keeping the laboratory clean and tidy - Perform rigorously, accurately, efficiently and professionally all cleaning and tidying activities in accordance with applicable GMPs and quality operating procedures. - Work with safety and have a quality performance, alerting colleagues or superiors about any potential risks and suggesting optimizations or improvements. - Show professionalism to colleagues. - Always keep the laboratory clean and tidy, so that there are conditions for the analysts to carry out their daily work. - Ensure the cleaning of existing equipment in the laboratories that is assigned as their responsibility. - Ensure cleaning, tidying and the existence of sufficient and required material for the execution of analyses, alerting analysts whenever they are occupying a lot of material. - Ensure the replacement of consumables, whenever necessary. - Ensure the existence of stocks of reagents and laboratory consumables, so that there are no delays in analyses due to lack of reagents/material. - Allocate external orders/reservations to the correct cost centers. - Carry out any additional tasks to support laboratory activities as needed. - Look for additional information when felt that the available information is not enough. - Provide solutions to problems in unusual or infrequently occurring situations, based on existing precedents or procedures - Organize their time to perform all the tasks necessary for the proper functioning of the laboratories in a timely manner, prioritizing tasks responsibly. - Reorganize the work, autonomously, in case of unforeseen events that may occur throughout the day. - Follow all annual performance review requirements, including completion of the self-assessment. - Provide training in the specific skills of laboratory assistants to new members of the team (permanently or temporarily). - Ensure compliance with the training plan within the defined deadlines. - Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.

- Study, review, optimize and apply HSE Process safety procedures, proposing improvements as appropriate; - Communicate and engage with internal and external stakeholders, advising and liaising as appropriate; - Provide subject matter support, working to enhance site HSE capabilities and performance in a responsive and professional manner; - Coordinate, implement, support and maintain an effective management HSE Process Safety Management System at the site to assure and promote site compliance with all applicable legislation, policies and operating procedures; - Identify and propose improvements to the HSE Management System in order to maintain compliance with legal requirements, best practice and Hovione strategic plans; - Evaluate the Safety and Environmental Risks associated with New Process Introductions as well as modifications to existing Processes to determine the necessary controls required to ensure safety; - Conduct technical assessments of new equipment and facilities utilizing recognised formal risk assessment methodologies as appropriate to the assessment e.g. Hazop, PHA, LoPA, etc; - Identify and assess Major Accident Scenarios as required under the Comah regulations and in line with company procedures; - Maintain and update Hazard Area Classifications; - Conduct Chemical Risk assessments; - Verify and monitor site compliance with HSE Process Safety requirements and procedures, producing and presenting reports; - Maintain accurate statistical data and records related to HSE Process Safety activities; - Support and provide relevant training in accordance with established training plans, proposing topics as appropriate and updating plans according to Hovione needs; - Provide technical support to the operating and manufacturing operations to help resolve issues and determine best practice relating to site safety and environmental performance; - Establish procedures and practices to maximise the effectiveness of the site emergency preparedness response; - Participate and lead as required, investigations into HSE events to identify appropriate corrective actions; - Plan, participate and support internal audit programmes to routinely verify the continuing effectiveness of the site HSE Management System; - Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others).

Enables the efficient manufacture of pharmaceutical products, including highly potent compounds, in compliance with applicable cGMP and HSE regulations and in accordance with business requirements. Responsible for the definition, implementation and optimization of manufacturing processes and systems, aiming at full adherence to pre-established schedules while managing internal resources (people & equipment) and fulfilling costumer requirements.   - Rigorously, efficiently and professionally, execute all production/HSE activities, adhering to all applicable procedures and following instructions received from ascending colleagues. - To execute, with supervision, the production/HSE processes. - Ensure all documentation under direct responsibility is correctly completed and maintained. - Be an advocate for safe operating and high quality performance, alerting ascending colleagues to any potential risks and suggesting production/HSE optimizations or improvements. - Develop and accumulate strong production/HSE knowledge. - Demonstrate professionalism in the workplace. - Ensure facility activities are carried out in compliance with all GMP, legal and HSE regulations and applicable standards in the country of operation, complying with and enforcing all Hovione processes and good practice. - Be responsible for the safe and efficient operation of various equipment (which may vary according to the Production/HSE Area in which the TM are allocated). - Maintain clean and organized facilities. - Attend and participate fully in all meetings and training to which the TM is invited. - Maintain an open communication with colleagues, identifying and reporting any production, HSE, quality or other issues to management according to the required processes. - Suggest and participate in improvements in the area in which the TM is assigned. - Ensure that all equipment is checked and calibrated before use. - Ensure the correct identification and use of equipment (labels, plates, logbooks, etc.). - Prepare samples (according to the Area in which the TM is allocated). - Execute production/HSE tasks correctly in Hovione systems (including but not limited to SAP, LIMS, SchedulePro etc.). - Use the Personal Protective Equipment and keep it in good condition. - Use computer programs correctly (including but not limited to email, SAP, LIMS, SchedulePro and XNET). - Collaborate in the revision of any area documents as requested (IOPs, others). - Collaborate in internal and external audits / inspections as requested. - Participate, as required, in the induction and training of new Operators across Hovione, Collaborate in the integration of the transferred Operators from other areas. - Follow all annual performance review requirements, including completion of the self-assessment. - Ensure facility activities are carried out in compliance with all GMP, legal and HSE regulations and applicable standards in the country of operation, complying with and enforcing all Hovione processes and good practice. - Undertake any additional tasks commensurate with the role as and when required. - Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.

An ON SITE Operator position at our East Windsor, NJ location. This shift is 2nd shift starting at 2:30pm - 8 h shifts - M-F with occassional scheduled OT. ~~~~~~~~~~~~~~~~~~~   Enables the efficient manufacture of pharmaceutical products, including highly potent compounds, in compliance with applicable cGMP and HSE regulations and in accordance with business requirements. Responsible for the definition, implementation and optimization of manufacturing processes and systems, aiming at full adherence to pre-established schedules while managing internal resources (people & equipment) and fulfilling costumer requirements.   - Rigorously, efficiently and professionally, execute and lead all production activities, adhering to all applicable procedures and following instructions received from ascending colleagues. - Be able to temporarily delegate for the Team Lead (where appropriate) - Be an advocate for safe operating and high-quality performance, alerting ascending colleagues to any potential risks and suggesting production optimizations or improvements. - Ensure all documentation under direct responsibility is correctly completed and maintained. - Develop and accumulate strong production knowledge. - Demonstrate professionalism and support the induction and training of new operators. - Lead production processes and coordinate colleague execution of production activities. - Take a lead in the induction and training of new operators - share expertise and practical knowledge. - Act as a subject matter expert to less experienced colleagues. - Ensure facility activities are carried out in compliance with all GMP, legal and HSE regulations and applicable standards in the country of operation, complying with and enforcing all Hovione processes and good practice. - Be responsible for the safe and efficient operation of various equipment (which may vary according to the Production Area in which the TM are allocated). - Maintain clean and organized facilities. - Attend and participate fully in all meetings and training to which the TM is invited. - Maintain an open communication with colleagues, identifying and reporting any production, HSE, quality or other issues to management according to the required processes. The TM is expected to previously assess and proactively propose solutions for the identified issues. - Ensure that all equipment is checked and calibrated before use. - Ensure the correct identification and use of equipment (labels, plates, logbooks etc.). - Prepare, train and supervise sample process (according to the Area in which the TM is allocated). - Manage and execute production/HSE tasks correctly in Hovione systems (including but not limited to SAP, LIMS, SchedulePro etc.). - Use the Personal Protective Equipment and keep it in good condition. - Use computer programs correctly (including but not limited to email, SAP, LIMS, SchedulePro and XNET). - Collaborate in internal and external audits / inspections as requested. - Suggest and lead improvements in the area in which the TM is assigned - Organized and manage the revision of any area documents as requested (IOPs, others). - Collaborate in the integration of the transferred Operators from other areas. - Troubleshoot systems and take appropriate action as required. - Actively collaborates in investigations of abnormal/unexpected events. - Support the Production Team Leader / Supervisor in the execution of their duties as required. - Follow all annual performance review requirements, including completion of the self-assessment. - Ensure facility activities are carried out in compliance with all GMP, legal and HSE regulations and applicable standards in the country of operation, complying with and enforcing all Hovione processes and good practice. - Undertake any additional tasks commensurate with the role as and when required. - Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.

Delivers excellence in end-to-end process improvement practices, methodologies and behaviours to achieve transversally operational and support services areas’ efficiencies. Demonstrates particular leadership skills to influence the right behaviours and enable alignment of priorities across areas. Supports the continuous improvement cycle aiming at the sustainable increase of unitary output (effective throughput per resource unit used). Responsible for developing, deploying and maintaining the most adequate methodologies and workflows, looking at maximization of workforce efficiency and adoption of the appropriate behaviours to enable engagement; as well as for deriving metrics to measure plant and equipment capacity to support identification of equipment and process flow bottlenecks, contributing to improved layouts whilst assuring compliance with established guidelines.   - Implement productivity actions and define priorities within own work to achieve the proposed goals (efficiency, efficacy and cost consistency) - Drive, manage and train the teams that will take part on Continuous Improvement Initiatives, problem solving and risk assessment groups - Coach operational teams in their daily communication meetings, ensuring that defined methods are properly used in all areas - Support the development of Operational Excellence Training Program and run training sessions - Update the productivity indicators of the plant - Support a Continuous Improvement process in the plant that is visible for all, through indicators, working methods, visual management, etc. - Ensure the constant reduction of the time and costs required in all activities in Manufacturing - Ensure that all operational staff are trained according to Operational Excellence training procedures in place - Ensure all assigned tasks are planned and delivered on time, safely, efficiently, reliably and in a cost-effective manner - Propose improvements to the area as appropriate and solve problems - Make quality and timely decisions within the tasks under her / his responsibility - Gather relevant data to inform the decision makers regarding complex issues - Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others) - Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.

  - Develop own knowledge and skills within the HR discipline and the wider business, in order to provide technical support HR Team and internal customer. - Payroll end to end, ensuring that all the payroll calculations are made correctly and accurate reports are provided to the Snr HR Business Partner. - Monitor and support a range of processes and systems of the HR department to ensure that they are effectively maintained and coordinated within Hovione's procedures, guidelines. - Prepare management information indicators with relevant data to assist management decision making within the department. - Respond to standard employee enquiries and issues with work process area, escalating where necessary. - Follow and measure the impact and ensure update of legal requirements related with work labor law or collective agreement; - Manage and provide support to employees regarding the insurances (Work Accidents, Life, Health, Personal Accidents & Retirement; - Provides support to HR for organizational changes and organizational design initiatives - Manage and ensure that all legal and internal procedures are followed when hiring new TMs (medical exams, documentation, government applications etc); - Gather relevant data to inform the decision makers regarding complex issues - Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others). - Provide administrative assistance to the HR Department.

Responsibility over the development, scale-up, registration / validation of drug substance, particle engineering and drug development programs in compliance with legislation and regulatory standards of Quality, HSE and cGMP policies. Oversees the manufacturing process for clinical or commercial supplies of materials in cooperation with areas and supports safety/hazard analysis and other technical support areas as required. Promotes the scientific excellence and innovation in the area and contributes with technical expertise to expand the Intellectual Property, product and technology portfolios.   - Apply strategic-thinking and forward planning to the area projects and implement the necessary actions to promote faultless execution - Assure the adequate planning of area activities in line with clients and internal requirements and ensuring the liaison with relevant third parties - Ensure that all projects are staffed appropriately and that the materials requirements of the area are met to guarantee all area’s responsibilities are met and the group is able to exceed customers’ expectations - Ensure the information flow between all R&D areas and other relevant stakeholders - Ensure scientific development activities occur with the right level of guidance and technical know-how - Propose new technologies and methodologies and the necessary investments and resources taking in account both specific driven project objectives and the group scientific and technical objectives and support in their implementation - Review and approve the protocols, reports and documentation prepared in the Area - Ensure the continuous improvement and subsequent implementation of new methodologies that can efficiently support process development - Promote scientific activities (i.e. seminars, congress participations, innovation ideas, papers and publications) and innovation within the team and encourage the sharing of knowledge with other teams - Be part of problem-solving processes as required by the team - Coordinate the TMs assigned to his/her area of responsibility, namely in terms of recruitment, integration, training needs and performance management in accordance with the company's HR policies, in order to ensure all TMs are aligned and motivated towards achieving Hovione's goals, values and culture by promoting their personal and professional development whilst maximizing productivity. - Develop and propose for superior approval the activity plan and related budget for the Area under responsibility in line with the unit's strategy, in order to align activities with area strategic objectives - Monitor area´s budget, by controlling budget evolution, identifying any deviations between the real and the foreseen and taking corrective measures - Ensure compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others) within his/ her TMs - Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice

• Create, revise and monitor product roadmaps according to the strategic goals, the user requirements and the functional specifications, working in partnership with IT business analysts • Define scope and backlog items of software development projects, guiding the application developers and managing the release/sprint goals • Ensure the application developers have an adequate amount of prior prepared tasks to work on • Possess an understanding of end-to-end customer experience integration and dependencies, gathering information from UI/UX specialists and communicating to application developers • Collaborate with stakeholders during the visioning and concept development of products • Develop and maintain an appropriately prioritized backlog of user stories for implementation • Review and/or develop detailed specifications for the product features so they are understood by the application developers • Plan product release and set the expectations for delivery of new functionalities • Create and continuously update a product inventory, reviewing and auditing products regularly, to identify issues and propose enhancements • Research and analyze market, competitors, the industry and the users continuously • Keep abreast with agile/scrum best practices and new trends • Ensure all assigned tasks are properly planned and delivered on time, safely, efficiently, reliably and in a cost-effective manner • Propose improvements to the area as appropriate and solve problems • Act as the voice of the customer to guide all stages of software development, including user story development, sprint planning, and prioritization of the product backlog • Make quality and timely decisions within the products under her / his responsibility • Gather relevant data to inform the decision makers regarding complex issues • Comply with all IT governance, standards and policies in practice in Hovione • Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others) • Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.

- Ensure all assigned tasks are properly planned and delivered on time, safely, efficiently, reliably and in a cost-effective manner - Propose improvements to the area as appropriate and solve problems - Make quality and timely decisions within the tasks under her / his responsibility - Gather relevant data to inform the decision makers regarding complex issues - Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others) - Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice

Defines and implements quality control techniques in order to verify the quality of raw materials, intermediate and end products as well as any other analytical services relevant to our client base and according to regulatory requirements. Manage and control all Quality Control activities in accordance with identified quality assurance standards, company procedures, client specifications, contract requirements, and regulatory guidelines.     - Coordinate and supervise activities within the area and prioritize activities in case of conflict between simultaneous production lines / projects to ensure that the deliverables of each project are dealt in the team within the timeframes defined, with the appropriate quality and according to cGMP and that an outstanding service is provided to all customers (internal and external) - Ensure that all TMs of the team have suitable training and qualifications to the work they perform - Participate in client meetings, external and internal audits and Product/Project teams representing own area specialization - Review and approve analytical test methods to be executed in own laboratory - Review and approve reports prepared in own laboratory - Check and approve raw material, intermediate and final product batches, stability samples, In Process and COL samples and/or all samples sent for QC from own laboratory - Manage all defined stability programs in terms of protocl preparation, inventory management, analytical testing execution and data release - Ensure all safety and quality events are investigated and root cause determined with CAPA’s identified and executed - Coordinate the timely execution of the preventive maintenance program and execution of corrective maintenance. - Keep up to date on new analysis techniques relevant to the laboratory, by means of literature, training, seminars or conferences - Coordinate the TMs assigned to his/her area of responsibility, namely in terms of recruitment, integration, training needs and performance management in accordance with the company's HR policies, in order to ensure all TMs are aligned and motivated towards achieving Hovione's goals, values and culture by promoting their personal and professional development whilst maximizing productivity - Develop and propose for superior approval the activity plan and related budget for the Area under responsibility in line with the unit's strategy, in order to align activities with area strategic objectives - Monitor Communication´s budget, by controlling budget evolution, identifying any deviations between the real and the foreseen and taking corrective measures - Ensure compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others) within his/ her TMs - Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.

Performs maintenance on equipment and systems (e.g., mechanical, electrical). Evaluates and recommends equipment improvements to increase reliability, capability and yield. Performs equipment condition analysis (during preventive and unscheduled maintenance). Troubleshoots and diagnoses equipment problems / failures. Prepares technical reports to document equipment modifications and equipment maintenance procedures.   - Ensure the maintenance, service, repair and troubleshoot of all equipment and installations (mechanical / electrical / instrumentation) on site is performed as per Standard Operating Procedures, Maintenance work instructions or engineering best practices - Participate in risk assessment of work permits and control of their appropriate execution - Actively participate in the implementation of continuous improvement initiative and lean tools within the area (TOP meetings, TPM, 5S, SMED, 8D) - Participate in the Quality Assurance and HSE programs, guaranteeing the timely implementation of corrective actions (CAPA) - Assist in the training of more junior members of the maintenance area in their area of expertise - Ensure the correct completion of all required documentation, paper or system based, associated with own and area work - Ensure proper tidiness and cleanliness of the maintained equipment and area as well as of his/her working area - Ensure that area or his/her assign tolls are kept in good shape in what regards to their functionality and cleanliness - Collaborate in the analysis / investigation of irregularities or CAPAs pertaining to area - Ability to choose the appropriate methods or tools - Ability to provide training and support colleagues - Follow established procedures and processes, with the ability to interpret instructions, drawings and equipment technical documentation - Resolve non-complex problems related to discipline, with more complex issues being referred to line manager or technical team member. - Adapt to changing site priorities Support other team members in prioritizing work - Provide guidance and support to colleagues informally - Maintain an open communication with colleagues, identifying and reporting any production, HSE, quality or other issues to management according to the required processes - Ensure facility activities are carried out in compliance with all GMP, legal and applicable standards in the country of operation, complying with and enforcing all Hovione processes and good practice - Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice - Undertake any additional tasks commensurate with the role as and when required.

Implements and manages the required guidelines and cGMPs for Hovione, providing LEAN based Quality Systems and Tools, controlled, harmonized and aligned with the company’s strategic plan, promoting a rigorous and continuous improvement culture to guarantee high quality compliant sites. Maintains active and efficient communication channels along the several Hovione sites, identifying Quality needs and improvements both from internal and external stakeholders. Evaluates, advises and provides services and technical support, internally and externally, related to the legal and scientific regulatory requirements in relation to product development, commercialization and optimization across the full product lifecycle to ensure compliance with both global and local regulatory legislation, guidelines, inspections, audits and other regulatory due diligence. Represents Hovione through communications and negotiations with regulatory authorities, preparing, submitting and managing all matters related to regulatory submissions and licensing for Hovione and customer products; and within professional associations, industry/trade groups.   - Assist in execution of post approval and shared services compliance activities - Compile, prepare and assist in the preparation of updated documentation to be submitted to regulatory authorities - Search and select regularly updated information on legislation, regulations and guidelines - Prepare routine reports and regulatory agency communications - Prepare communications and technical packages for customers - Prepare regulatory plans for revised submissions with specific deliverables and timelines - Prepare the annual assessment for the submitted filings - Compile and prepare updated regulatory filings to authorities: amendments / variations, annual reports - Assist in the implementation of internal procedures and systems to track and manage documentation and tasks - Apply and develop knowledge of Regulatory Affairs and participate in area processes, procedures and projects with the guidance of more senior colleagues - Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice. - Perform to ensure all assigned tasks are delivered on time, safely, efficiently, reliably and in a cost-effective manner - Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others).

Defines and implements quality control techniques in order to verify the quality of raw materials, intermediate and end products as well as any other analytical services relevant to our client base and according to regulatory requirements. Manage and control all Quality Control activities in accordance with identified quality assurance standards, company procedures, client specifications, contract requirements, and regulatory guidelines.   - Rigorously, accurately, efficiently and professionally manage, execute and support all assigned projects in accordance with applicable GMP, quality operational standards / procedures and legal regulations, escalating as appropriate - Propose new methodologies taking into consideration project demands and requirements - Execute project specific analytical tasks and act as a stakeholder liaison - Provide an example of professionalism and support the induction and training of new colleagues within the area - Ensure that all assigned analytical tasks, including (but not limited to) method development, method creation, method transfer, method validation, protocol preparation and report preparation, in any analytical project is well managed and delivered on time, safely, efficiently, reliably and in a cost-effective manner by performing and planning - Solve analytical problems relating to assigned projects by providing collaborative and timely support to all areas and departments, initiating the problem-solving escalation process when unable to solve occurrences within the established period - Ensure the effective and proactive flow of information between the Analytical team and the internal and external (if applicable) stakeholders, representing the team as appropriate - Reviews work generated by the team as required ensuring all procedures are followed - Creation, investigation and evaluation of CAPAS, incidents and deviations - Perform equipment maintenance, internal calibrations and internal qualifications on designated laboratory instruments - Accurately use and maintain all laboratory information systems - To maintain good hygiene and housekeeping within the laboratory - To maintain all laboratory records, project and general logbooks and notebooks to an acceptable GLP standard and in accordance with Hovione internal procedures - Fulfil and promote all applicable GMP requirements and HSE regulations, adhering to all relevant Operating Procedures and industry standards in conducting all analytical activities - Be an advocate for safe operating and high-quality performance, alerting ascending colleagues to any potential risks, discrepancies, deviations or non-conformance in accordance with Hovione internal procedures, suggesting optimizations or improvements - Assist with audits / investigations as required, following the instruction of QC Management - Support the generation / reporting of KPIs for the team, if required - Develop and accumulate strong analytical chemistry expertise, sharing knowledge of new technologies and methodologies within the area - Provide relevant training to other areas in accordance with established training plans - Participate, as required, in the induction and training of new colleagues - Drive high standards in the QC Laboratories - Use analytical techniques and instrumentation, such as gas and high-performance liquid chromatography (HPLC) amongst others - Interpretation of data and analysis to ensure meeting strict guidelines on documentation and recording data - Work collaboratively in cross-functional teams and understand each departments function and role in delivery of tests and products - Ensure all assigned tasks are planned and delivered on time, safely, efficiently, reliably and in a cost-effective manner - Propose improvements to the area as appropriate and solve problems - Make quality and timely decisions within the quality control tasks under her / his responsibility - Gather relevant data to inform the decision makers regarding complex issues - Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others) - Undertake any additional tasks commensurate with the role as and when required - Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice. - Must have the Knowledge, Experience and Skills to conduct their tasks in accordance with the rules and procedures set down.