This role is an ON-SITE role at our East Windsor, NJ facility: 3rd shift (9:30pm - 6:00am) 8 hr, M-F with pay differential and bonus.
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.
- 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
- Procedures, maintenance work instructions or engineering best practices
- 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
- Ensure the correct completion of all required documentation, paper or system based, associated with own work
- 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)
- Ensure proper tidiness and cleanliness of the maintained equipment and area as well as his/her working space
- Ensure that area or his/her assign tools are kept in good shape in what regards to their functionality and cleanliness
- Participate in programs and initiatives required to ensure plant cleanliness
- Follow procedures with clear instructions; seeks clarification if they are not clear
- Work follows an established pattern, with a requirement to run standard procedures, analysis, reports or tests
- 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
- 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 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 practices
- Undertake any additional tasks commensurate with the role as and when required
Define and implement 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.
This is a 4 cycle shift based role within our In-Process Control Team.
- To organize and define daily priorities within their assigned tasks in order to accurately and promptly perform the allocated sample analysis to meet the requirements of the periodic laboratory plan and area KPIs.
- To adhere to the laboratory testing schedule in order to achieve an efficient Quality Control (QC) system.
- Take responsibility for all data individually generated and ensure it is in accordance with all applicable GMP requirements and HSE regulations, adhering to all relevant Operating Procedures and industry standards in conducting all analytical activities.
- To maintain all checklists, laboratory records and notebooks in which he/she is involved to an acceptable GMP standard and in accordance with Hovione internal procedures.
- To perform routine calibration and both corrective and preventative maintenance of designated laboratory instruments, requesting any instrument parts and consumables required by the area.
- To bring any discrepancies, deviations or non-conformance in testing or work practice to the attention of QC management in accordance with Hovione internal procedures.
- To issue events and support the investigation of OOS/OOT/atypical results, deviations and QC incidents generated in the QC Laboratories.
- Ensure appropriate communication with other internal department in relation to QC work by using the appropriate Hovione processes and their IT platforms.
- Assist with audits as required, following the instruction of QC Management.
- Undertake any additional tasks to support the laboratory activities as and when required.
- Follow all annual performance review requirements, including completion of the self-assessment.
- 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 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.
- Solve analytical problems relating to assigned projects by providing collaborative and timely support to all areas and departments;
- Ensure the effective and proactive flow of information between the Analytical team and the internal and external (if applicable) stakeholders, representing the team (with support from senior colleagues) 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;
- Fulfil and promote all applicable GMP requirements and HSE regulations, adhering to all relevant Operating Procedures and industry standards in conducting all analytical activities;
- Assist with audits / investigations as required, following the instruction of QC Management;
- Support the reporting of KPIs for the team, if required;
- 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;
- Ensures all assigned Total Rewards´ tasks to the relevant supporting group(s) are properly planned and delivered on time, safely, efficiently, reliably and in a cost-effective manner.
- Assists with the development and execution of specific compensation solutions to meet identified needs based on understanding of supporting group(s)’s business environment, goals and objectives.
- For assigned subject matter expert areas (job architecture, competitive compensation, mobility, recognition, perquisites and benefits programs, Total Rewards systems and strategic rewards projects), supports the design, implementation and monitoring of global policies and programs that are market-competitive, cost-effective and reinforce Hovione pay-for-performance philosophy. Serves as the escalation point for HR Operations and HR Business Partners.
- Following the guidance of the relevant Total Rewards SME, coordinates the annual review process (incentives, merit award planning and communication processes) for assigned supporting group(s). Coaches support group(s) in the application of program principles. Partners with HR OPS/HR BPs in program execution.
- Is knowledgeable of global/ regional Hovione´s HR, Total Rewards philosophies, policies, programs, goals and objectives. Understands the implications of local decisions on the broader organization. Exercises judgment to inform others and escalate issues for resolution.
- Manages and/or participates as a team member in assigned Total Rewards projects. Is knowledgeable of and leads or supports Benefits initiatives as requested.
- Assists the Total Rewards team with preparation of estimates, analyses and/or model costs/savings in support of payroll and benefits budgeting, labor relations, and strategic planning processes.
- 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).
- Carries 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.
- Consult with and provide guidance to assigned supporting group(s) on the application of Hovione’s job architecture, competitive compensation, mobility, recognition, perquisites and benefits programs, Total Rewards systems and strategic rewards projects.
- Develop and execute specific compensation solutions to meet identified business needs
- Assigned subject matter expert (SME) areas (job architecture, competitive compensation, mobility, recognition, perquisites and benefits programs, Total Rewards systems and strategic rewards projects), designs, implements and monitors global policies and programs that are market-competitive, cost-effective and reinforce Hovione pay-for-performance philosophy. Serve as the escalation point for HR Operations (HR OPS) and HR Business Partners (HR BPs).
- Follow the guidance of the relevant Total Rewards SME, coordinate the annual review process (Coaches allocated supporting group(s) in the application of program principles. Partner with HR OPS/HR BPs in program execution.
- Be knowledgeable of global/ regional Hovione´s HR, Total Rewards philosophies, policies, programs, goals and objectives. Understands the implications of local decisions on the broader organization.
- Educate assigned supporting group(s) on Hovione’s Total Rewards philosophy, policies, programs, goals and objectives. In collaboration with the relevant Total Rewards SME, rolls-out communication materials and training modules, adapting it as needed to fit audience needs and perspectives.
- Support large-scale organization change initiatives, merger and acquisition activities, divestitures, competitive reviews, systems upgrades, as needed.
- Manage and/or participate as a team member in assigned Total Rewards projects. Is knowledgeable of and leads or supports Benefits initiatives as requested.
- Prepare estimates, conduct analyses and/or model costs/savings in support of payroll and benefits budgeting, labor relations, and strategic planning processes.
- 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).
Performs qualitative and quantitative analyses of compounds, including drug substances, drug product intermediates and drug product. Recommends the analytical characterization package (Chemical, physical, performance) and controls the quality and accuracy of the data in compliance with legislation and regulatory standards of Quality, HSE and cGMP policies. Promotes the scientific excellence and innovation in the Analytical area and contributes with technical expertise to expand the Intellectual Property, product and technology portfolios.
- Perform and provide support to the development of analytical methods and the implementation of innovative and new analytical methodologies
- Coordinate priorities with Area responsible and Project manager to ensure that the timelines of the analytical work (such as method development, validation protocols, validation execution, and validation reports) of the project are met
- Prepare and revise analytical reports and protocols
- Actively participate in investigations and propose corrective and preventive actions (CAPA)
- Discuss actively with customers technical and scientific issues of projects under own scope
- Support client visits
- Discuss and review analytical data generated by the team
- Provide training internally and to other areas as required
- 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 Analytical 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.
Performs qualitative and quantitative analyses of compounds, including drug substances, drug product intermediates and drug product. Recommends the analytical characterization package (Chemical, physical, performance) and controls the quality and accuracy of the data in compliance with legislation and regulatory standards of Quality, HSE and cGMP policies. Promotes the scientific excellence and innovation in the Analytical area and contributes with technical expertise to expand the Intellectual Property, product and technology portfolios.
- Perform and provide support to the development of analytical methods and the implementation of innovative and new analytical methodologies
- Coordinate priorities with Area responsible and Project manager to ensure that the timelines of the analytical work (such as method development, validation protocols, validation execution, and validation reports) of the project are met
- Prepare and revise analytical reports and protocols
- Actively participate in investigations and propose corrective and preventive actions (CAPA)
- Discuss actively with customers technical and scientific issues of projects under own scope
- Support client visits
- Discuss and review analytical data generated by the team
- Provide training internally and to other areas as required
- 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 Analytical 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.
Participate in Global Automation industrial information and system lifecycle projects. Maintain and develop standards, procedures and specifications for systems hardware, software, interfaces, and data acquisition in compliance with internal and external guidelines. Develop and maintain standard system health monitoring tools. Invest in continuous improvement and innovation.
- Define requirements, plan, and manage new Global Automation operations technical systems projects or changes to the existing ones
- Develop and review specification, testing document templates, as well as internal and standard operating procedures (IOP, SOP)
- Propose innovative solutions that minimize investment and maintenance costs, while maximizing returns
- Define system interface and integration standards
- Support systems integration projects such as new systems, existing systems migrations or upgrades, and expansions
- Support automation systems lifecycle, including inventory and risk management
- Define system architecture and infrastructure requirements
- Collaborate in the definition of strategies for industrial data acquisition and reporting and asset monitoring across sites
- Collaborate with Automation sites to support exchange proven practices and standards
- Collaborate in internal / external audits and inspections
- Follow HSE program, participate in PHA, FMEA and HAZOP
- Engages in the implementation of the Health, Safety and Environmental Management and Sustainability programs and procedures to safeguard employees and surrounding communities, developing requirements, supporting implementation through training and communication and monitoring implementation through audit and inspection. Conducts and supports incident investigations and risk assessments. Develops and maintains comprehensive knowledge and familiarity of regulatory and organization requirements and standards and works to ensure these requirements are fully implemented.
- Develop & Maintain a competences framework covering the areas of Health Safety & Sustainability (HSS).
- Establish and maintain HSE Academy curricula appropriate to risks and regulatory requirements and aligned with Global and Site needs.
- Working with stakeholders, establish and lead a governance process for the development of transversal training content to maximize efficiency and effectiveness and support as necessary the development of site/function specific content as needed.
- Working with stakeholders establish and lead a governance process for the approval of trainers for the HSE Academy ensuring trainers have the appropriate experience, knowledge, and competency to deliver assigned training.
- Develop and review as appropriate learning support materials for trainers to ensure transversal training is delivered in a manner which is consistent across the company.
- Work the Global Human Resources and Learning & Development to ensure the effective roll out and operation of the Hovione Learning Academy.
- Monitor Performance KPIs for L&D within HSE and generate training status reports for management.
- Develop and propose for approval an annual activity plan and related budget for the Area under responsibility in line with the unit's strategy, to align activities with the department strategic objectives
- Monitor the approved HSE L&D budget, identifying any deviations against plan and taking corrective measures as necessary.
- Promote the introduction of innovative Learning & Development methodologies or technologies during the revision and implementation of the training contents.
- Promote compliance on Health, Safety, Environment and Sustainability, including the prevention of major accidents hazards, by exercising good governance and through the implementation of policy, procedures, and training.
- Working with stakeholders and in alignment with Global Communications, develop and lead the implementation of a communication plan in support of company objectives in the areas of Health, Safety & Sustainability.
- Support the work Global Health Safety & Sustainability.
- Defines and implements business processes that assess overall performance, identify business drivers, benchmark against relevant KPIs, identify improvement opportunities and promote business process optimization.
- Defines, produces timely and challenges reports that address performance against budget, profitability, cost, efficiency and risk.
- Prepare, monitor and control the annual departmental budget under responsibility to ensure expenditure is in line with the company business plan
- Administer all departmental financial and operational information in the appropriate systems
- Develop and monitor business performance metrics for the department, acting as a partner of managers and directors and understanding the department or area strategic challenges
- Execute regular and specific complex reports for the department related with operational and financial KPIs, as requested by managers and directors
- Conduct forecasts with financial and operational information
- Support project managers within the department, analyzing project costs to ensure that budgeted costs are in compliance
- Conduct specific analysis related with the department, improving data reporting and analysis
- Provide financial and accounting advice to directors and managers within the department
- Master controlling processes and tools
- Manage complex projects/ analysis with significant impact on business
- Make quality and timely decisions based on multiple sources of data
- Manage risk and uncertainty; anticipate and escalate roadblocks in order to prevent deviations to the goals
- 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)
The Project Manager will deliver win-win cost-effective solutions on time and in full through focused project teams speaking in one voice, working in an efficient and collaborative environment, thereby leading to long-term sustainability with satisfied stakeholders, including customers, suppliers, sponsors and team members. This key resource will be able to lead the project teams, plan, set priorities, monitor and control, and take the decisions that result in delivery as per the agreed scope, budget and timeline. Maximizing financial performance and optimizing customer satisfaction are central to the function..
The most successful candidate will possess some degree of knowledge of solid oral dosing, commercial planning, knowledge of FDA processes, GMP/cGMP, QA, et al.
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Delivers win-win cost-effective solutions on time and in full through focused project teams speaking in one voice, working in an efficient and collaborative environment, thereby leading to long-term sustainability with satisfied stakeholders, including customers, suppliers, sponsors and team members. Lead the project teams, plan, set priorities, monitor and control, and take the decisions that result in delivery as per the agreed scope, budget and timeline. Maximizing financial performance and optimizing customer satisfaction are central to the function.
- Manage projects in the allocated area and escalate complex issues to more senior colleagues or managers. It is recognized that the level of support required will increase when projects that are more complex are assigned. Project assignment will always be based on business need, however, preferentially, projects assigned will have a low to medium degree of complexity including:
- a low to medium cumulative sales / project cost value
- a low to medium to high project control level
- up to a medium customer segmentation level
- Proactively manage and take responsibility of the scope, cost, time and quality of each project assigned
- Deliver the project objectives (e.g. results, processes, products) through a structured approach in alignment with industry or Company best practices
- Lead the project team to take decisions or to decide to escalate the decision based on data
- Contribute to the project team composition and selection
- Clarify project team roles and responsibilities
- Communicate proactively and effectively internally and externally
- Build and sustain motivation of the project TMs and positive dynamics within the project team
- Give timely and specific feedback to the project TMs regularly, both positive and constructive
- Keep up to date on the best PM practices, standards and methodology in use within the industry
- 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 project management tasks under her / his responsibility
- Gather relevant data to inform the decision makers regarding complex issues
- Comply with all applicable 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
The Administrative Assistant is responsible for provides support to employees or groups within Hovione. Receives, screens and directs incoming calls, visitors, mail and email. Maintains files, records, calendars and diaries. May arrange business travel, coordinate meeting arrangements and / or track expenses. Uses standard and/or advanced business software applications (e.g Microsoft Office, SAP, documentation control, analytical software) to prepare correspondence, presentations, agenda, minutes, etc. Acts as key user for area specific tools. Prepares technical reports, document or indicators based on specialized documents. Updates planning and communications in support of decisions made.
- Receive, classify, consolidate and/or summarize documents and information using the tools and systems required for these purposes
- Maintain records of documents processed as required
- Compile various regular reports in accordance with standard operating procedures
- Route or answer routine correspondence not requiring supervisor attention
- Maintain a pleasant environment and receive and refer visitors and telephone calls
- Open and distribute mail
- Make meeting and travel arrangements
- Suggest and manage Employee wellbeing and site events
-Prepare purchase requisitions and follow-up with the area for completing the GRs
- Maintain and order a variety of office supplies
- Conduct simple tasks of low complexity and with close supervision
- 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 HSE regulations 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.
- Manage a multi-disciplinary team to carry out technical services in DPCM group.
- Ensuring proper development, transfer, validation, and & troubleshooting of spectroscopic and non-spectroscopic PAT methods, and orchestrations
- Provide technical support to the DPCM operations area (maintaining & troubleshooting equipment challenges)
- Interact with new customers to demonstrate and promote the value of Continuous Manufacturing
- Support the Business development team by drafting technical SOW’s for new business opportunities
- Approve changes to the facilities under his (her) responsibility.
- Assure compliance with HSEE and GMP policies
- Comply with all Federal, State and Local requirements, namely: EPA, OSHA and FDA.
- Staff the team according to the company strategy for the area, both in terms of headcount and skill set.
- Supervise the area projects aiming perfect technical execution, customer satisfaction and the achievement of the established objectives
- Promote continuously innovation and gains of knowledge within the company, proposing new differentiators (e.g. novel tools or methodologies) for the company.
- Ensure continuous communication, training and development of team members, so that the members are engaged and play a valuable role in the development of robust and profitable processes.
- Raise the profile of the Company through technical presentations/articles in the area of Continuous Manufacturing.
#drugproductcontinousmanufacturing, #pharmaceuticalmanufacturing, #CDMO
#solidoraldosing
Performs qualitative and quantitative analyses of compounds, including drug substances, drug product intermediates and drug product. Recommends the analytical characterization package (Chemical, physical, performance) and controls the quality and accuracy of the data in compliance with legislation and regulatory standards of Quality, HSE and cGMP policies. Promotes the scientific excellence and innovation in the Analytical area and contributes with technical expertise to expand the Intellectual Property, product and technology portfolios.
- Perform project analytical tasks for complex projects: e.g., method development, method and specification creation; method transfer, protocols and reports preparation.
- Solve complex project analytical problems
- Determine the amount of work/effort that is required to accomplish a scope of work and propose solutions that meet and exceed the Client’s expectations
- Discuss actively with customers on technical and scientific issues
- Supervise the activities of less experienced colleagues in the work group
- Prepare and discuss complex product specifications
- Conduct and supervise analytical investigations and contribute in the definition and implementation of corrective actions
- Support audits and client visits
- Evaluate and approve materials, supplier/qualification
- Provide training internally and to other areas as required
- Master Analytical Chemistry processes and tools
- Manage complex projects/ analysis with significant impact on business
- Make quality and timely decisions based on multiple sources of data
- Manage risk and uncertainty; anticipate and escalate roadblocks in order to prevent deviations to the goals
- 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.
- Define, propose for approval and guarantee the implementation of strategies for the areas under responsibility (Health, Safety and/or Environment), as well as action plans
- Act as an adviser for top management in the HSE areas of expertise
- Set targets for the areas of expertise, developing plans to meet those targets and overseeing their delivery
- Guarantee the effective implementation of appropriate HSE procedures in the areas of expertise, guaranteeing its updating in line with changes in legislation, regulation and company directives
- Oversee internal and external audits in the HSE areas of responsibility
- Propose the implementation of new measures and procedures related with the HSE areas of expertise to ensure the mitigation of risks
- Take part in accident / incident investigating, guaranteeing the identification of a root cause and the elaboration of mitigation plans
- Oversee the elaboration of management reports, briefings and KPI analysis as requested in the areas of expertise
- Guarantee the conduction of in-house training on the assigned areas of expertise
- Ensure risk assessment in the areas of expertise
- Maintain an extensive knowledge of the legislation and updates in the areas under responsibility
- 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 department strategic objectives
- Monitor own´s budget and Capex, 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.
- To assure and promote compliance on Health, Safety, Environment and Sustainability, including the prevention of major accidents hazards, by exercising good governance and through the implementation of policy, procedures, and training.
The Sr Account Manager, North America is responsible for the sales, complex contracts negotiation, and marketing of Hovione´s Products group in support of the off-patent APIs, excipients, inhalation devices, and integrated programs to potential and existing clients in North America and related territories. The Sr Account Manager is responsible to manage a range of ongoing commercial relationships and revenues in addition to generating new business growth in line with the strategic plan, annual budget, and 5 year business plan objectives. Responsibilities include promotion of Hovione’s IP position into complex deal structures aiming at maximizing value, IP generation potential, and integration between our Products and Services portfolio.
Other responsibilities include representing Hovione at trade shows and conferences, promoting technology platforms being developed by Hovione.
The position may be a remote or office based position requiring frequent travel of up to 50%.
- Responsibility for Account Relationship Management and Sales activities of Hovione´s Product Group in North America
- To deliver ambitious personal sales targets meeting the 5 year business plan.
- To lead the negotiation of complex long-term contracts including but not limited to supply agreements, joint development agreements, licensing agreements, and combinations thereof
- To identify novel opportunities based on customer input and needs for value creation and IP generation
- To manage the client interface and provide outstanding commercial service through fast, trustworthy and knowledgeable responses to customer demands.
- Cultivate and expand relationships with existing clients in order to successfully co-create value and maximize the client utilization of Hovione’s capabilities.
- Interface effectively with internal colleagues in different job functions and across global Hovione sites to ensure customer needs are met.
- To develop Technical Presentations and development plans for strategic accounts coordinate implementation.
- To grow Hovione sales in existing markets North America by proactively identifying new opportunities for the existing and emergent Products.
- To participate in the long-term strategy of the business by identifying opportunities to expand Hovione’s Product Solutions platforms in strategic market segments
- Monitor and report market activity and provide concise and insightful analysis on customer dynamics, market developments and competitor activity.
- Effectively manage data, including demand forecasting, within Hovione´s Customer Relationship Management system and through other platforms.
- Represent Hovione at key trade shows domestically and internationally.
- Travel to Hovione global sites in order to support customer visits and internal activities.
- Liaise with Production to assure costs are executed as per plan and assets corresponds to current and future need.
- Liaise with R&D to identify promising upcoming technologies and development of customized grade
- Liaise with the Sales team in the definition of a pricing strategy
- Liaise with Procurement in the implementation of a sourcing strategy
- Managing short-term goals and the product’s lifecycle, assisting in the definition of medium and long term goal
- Implementing and managing changes to ensure customer satisfaction, safety, quality, and area’s performance;
- Developing methods to assess products strengths and identify areas for improvement (Operational excellence, sourcing, RD, etc.).
- Analyzing product risks and proactively proposing solutions;
- Working on strategy with the Marketing Team to define the marketing strategy and offering based on market needs ;
- Reporting on product performance to executive team and directors
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Facilitate cross-functional Sales and Operations Planning and Execution processes in terms of supply response to demand forecast. Establish plans, 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.
- Anticipate and monitor potential scheduling/planning/data management challenges, taking actions to mitigate risks; troubleshoots scheduling / planning /data problems; facilitates and actively contributes to cross functional meetings; communicate and align alternative scenarios with other areas as defined in Planning and Data policies.
- Mentor and develop the team, to achieve the objectives of the business in terms of individual performance, supply planning and sustainability.
- Support the New Product Introduction and Sales process through capacity planning and the creation of planning gantts for proposed slots for new business.
- Work closely with Global & site Procurement team to ensure continuity of Raw material supply for site manufacturing.
- Partner with other areas within Hovione to identify efficiency improvements in planning, scheduling and data management, guaranteeing its implementation.
- 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/Data 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 & Supporting Accuracy;
- Create and communicate reports detailing the status of critical activities of on-going projects and KPIs.
- Propose and implement revisions on the planning, scheduling and data management processes used, guaranteeing an increased efficiency in operations planning.
- Create training modules in planning, scheduling and data management and conduct training sessions targeted at junior TMs and other areas within organization.
- Manage complex projects/ analysis with significant impact on business.
- Manage risk and uncertainty; anticipate and escalate roadblocks in order to prevent deviations to the goals.
- Execute professional activities in compliance with GMP and HSE guidelines.
- Deputise for Supply Chain Director when required.
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
- Support the Site Head of L&D regarding the core processes and tools (e.g. learning needs analysis; build annual training plans; support the design and development of new contents; measure training effectiveness; manage training in LMS).
- Support relevant stakeholders (e.g. trainers, Learning Delegate) to ensure that the L&D standard processes are followed and the training is effectively delivered.
- Provide support to the training delivery activities (e.g. logistics, communication, training calendar).
- Provide accurate reports to relevant stakeholders (e.g. managers, auditors), by collecting, analyzing, and summarizing data.
- Manage and support external training end-to-end.
- Ensure all assigned tasks are properly planned and delivered on time, safely, efficiently, reliably and in a cost-effective manner
- Provide guidance and support to colleagues informally
