The IA Senior Manager will lead the audit work and staff, interface with management and generally perform and review required fieldwork. They will execute audits in all locations of the company (this is a global role) to review and evaluate the effectiveness of the internal controls, reliability of the financial reporting as well compliance with internal standards and external laws and regulations.
The role involves up to 10% of travelling time depending on the audit assignment and is a hybrid job position.
- To assess adequacy of internal controls, efficiency and effectiveness of business processes, including identification of control gaps and recommendations for improvement opportunities arising from audit engagements.
- To plan, manage and execute audit assignments as per Annual Audit Plan.
- To review and finalize audit working papers and audit findings prepared by audit team members.
- To manage audit assignments, report progressively on status of engagement and ensure completion of audit assignment as per the Annual Audit Plan / agreed timeline.
- To supervise and assist team members in overall execution of targeted testing and risk assessments.
- To review and discuss audit findings, recommendation and corrective action plan with responsible personnel, process owner and relevant stakeholder.
- To perform follow up audit on findings reported to ensure management action are implemented accordingly.
- To periodically engage members of the management team, stay ahead with Company and industry developments and make adjustments to the internal audit activity, if .
- To perform any ad hoc assignments and projects as necessary.
- Lead the implementation of the corporate sustainability project, aligned with the company's strategic objectives;
- Identify opportunities to improve energy efficiency, reduce natural resource consumption and minimize environmental impacts;
- Coordinate and collaborate with cross-functional teams to implement sustainable initiatives in all areas of SC site;
- Conduct feasibility analyses and evaluate the implementation of clean technologies and innovative practices related to sustainability;
- Monitor and measure the company's environmental performance, setting targets and key performance indicators;
- Ensure compliance with applicable environmental regulations and sustainability standards;
- Communicate and promote sustainability efforts internally, engaging employees and encouraging active participation;
- Stay current on trends, best practices and technological advances in sustainability and environment;
- Identify Circular Economy Opportunities.
- Establish annual plans for improvement in accordance with past performance and company strategic goals;
- Define long term targets for Business Transformation Implementation;
- Mentor and facilitate teams that are implementing projects and problem solving;
- Coach functional area teams in their daily communication meetings, ensuring that defined methods are properly used in all areas;
- Coach Lean Leaders and/or Six Sigma Green Belts;
- Develop Operational Excellence Training Program and run training sessions across all levels of the company;
- Develop a Continuous Improvement (CI) process in the plant that is visible to all e.g. through indicators, working methods and visual management;
- Lead projects that result in major business process improvements for the company;
- Track and report project results to management, internally and externally;
- Work closely with Project Sponsor and Operational Excellence Director to continuously review process and to eliminate barriers in projects;
- Ensure that process improvements stay in place over time and assure their sustainability;
- Develop site culture initiatives to establish and maintain the operational excellence culture;
- Support the execution of Operational Excellence Maturity Assessment and other benchmarking exercises;
- Manage complex projects with significant impact on business;
- Make quality and timely decisions based on multiple sources of data.
Leading the team of Strategic Alliances as line manager reporting to the VP Business Transformation & Licensing
Develop and nurture a network of contacts in order to establish strategic partnerships with Universities, startup companies, business associations, and other relevant market or scientific players in areas defined as strategic for Hovione.
Manage the network in a comprehensive business development database
Identify internal challenges and unmet needs and find new solutions and new partners to solve problems and improve products and/or processes.
Identify, through the network of contacts, external solutions that may resolve internal needs or answer to unmet market needs that may become opportunities for Hovione
Perform preliminary evaluation of the potential partners and/or solutions based on defined processes and criteria.
Attend international meetings and conferences scouting for opportunities and presenting Hovione’s strengths and objectives as a partner
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 partnering project teams, plan, set priorities, monitor and control, and take the decisions that result in delivery as per the agreed scope, budget and timeline. Optimizing partner satisfaction and securing long-term successful partnerships are central to the function.
- Organize the projects and partnerships under responsibility in accordance with the mission and goals of Hovione, giving direction to project managers and supporting the resolution of complex issues, guaranteeing projects are delivered according to the assigned criteria (output, budget and timings)
- Propose new partnering projects and elaborate preliminary budgets, teams, activity plan and deadlines
- Propose and control long-term goals for the partnerships under responsibility, guaranteeing that partnerships follow a path in the appropriate direction
- Apply an evaluation method for the partnerships under responsibility to assess the partnerships’ successfulness and identify areas for improvement, analyzing risks and controlling KPIs
- Act as a facilitator of partnership projects, joining stakeholders and communicating key aspects of the partnerships
- Produce complex partnership status and KPIs reports and present it as requested
- Participate in strategic forums to discuss the future direction of Hovione’s collaborations and projects, contributing with analysis and insights
- Manage the TMs assigned to his/her/its 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 approval the short and mid-term goals, annual budget and budget plan for the partnerships and projects under responsibility in line with the corporate strategy, in order to align activities with Hovione strategic objectives
- Prepare and propose for superior approval the annual budget of partnerships and projects under responsibility, 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
- 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) within his/her/its 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
Delivers excellence in end-to-end process improvement practices, methodologies and behaviors to achieve transversally operational and support services areas’ efficiencies. Demonstrates particular leadership skills to influence the right behaviors 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 behaviors 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.
- Develop and apply knowledge of process optimization and participate in area processes, procedures optimization projects with the guidance of more senior colleagues
- Take part in Continuous Improvement Initiatives, problem solving and risk assessment groups
- Deliver training on concepts as per training plans in place
- Ensure that 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).
- 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.
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.
- Provide inspirational leadership to the team and strive for operational excellence, with higher quality, efficiency and at higher processing speed.
- Drive best practice and process efficiencies through continuous improvement increase overall efficiency;
- Benchmark shared services organization against other companies to identify and implement process improvements
- Identify and implement process and system improvements to
- Develop and provide KPIs and metrics to senior management
- Monitor the process of invoice posting for local and foreign vendors and liaising with third parties in case of irregularities
- Monitors vendor current account reconciliation with monthly statements and liaises with external auditors in this matter
- Provide technical guidance and assist less senior TM’s
- 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.
- Act as a subject matter expert to less experienced colleagues.
- Responsible for overall sales, promoting and supporting the organisation’s services portfolio.
- Activities include developing and implementing sales strategies; managing and growing existing customer relationships; and monitoring customer and competitor activity and industry trends.
- Builds and maintains effective long-term relationships and a high level of satisfaction with key senior-level decision makers at a biotech and large pharma accounts.
- Identify, develop and close new sales opportunities with existing customers.
- Creates demand for Hovione’s CDMO services.
- Adapt departmental plans and priorities to address commercial challenges.
- Proactively communicate and support departmental managers as needed.
- Achieve sales targets and ensure project delivery for assigned portfolio of customer accounts.
- Build internal network within Hovione and customer accounts.
- Lead negotiations of CDAs, Master Service Agreements and Commercial Supply Agreements for allocated accounts in close collaboration with the Regional and/or Senior Directors in Sales
- Coordinate with the global regulatory, production, quality, supply chain and R&D groups to provide a superior level of customer service.
- Analyze data, including demand forecasting, within Hovione´s Customer Relationship Management system for Europe to ensure accurate forecasting and reporting.
- Identify complex market trends and demands and proposing ideas for new technology and services.
- Monitor customer account and market activity and provide concise and insightful analysis on customer dynamics, market developments and competitor activity.
- Optimize the relationship with established clients through both strategic and tactical means including Key Account Plans, Account Growth Plans, Periodic Business Reviews, client visits and Satisfaction Survey Action Plans
- Attend and represent Hovione at key Trade Shows
- 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 assembly, qualification and automation of facilities, equipment and utility systems according to regulatory demands (cGMPs, FDA requirements, etc.), industry applicable guidelines and internal procedures. Contributes to the continuous improvement of systems to improve operations, providing them with the necessary automation technologies, capacity, reliability and in compliance with cGMP and project specifications.
- In the early designing phases, guarantee that cGMP and HSE requirements and adequate Engineering solutions are incorporated in the URS and design specifications
- Contribute to the design review phase of the Engineering projects to ensure that cGMP and adequate technical solutions are dully incorporated
- Execute the construction, assembly, commissioning and qualification of Engineering projects
- Create the installation plan and maintain a close follow up for Engineering Projects
- Guarantee the necessary resources, internal and/or external to meet project plans and to deliver the expected quality on time and on budget.
- Define and implement technical solutions for unexpected challenges during the construction, assembly and commissioning & qualification of facilities without compromising the design concept and the process functionality, quality and systems.
- Report and escalate promptly any relevant deviations to plans or objectives and make quality and timely decisions within the Engineering tasks under her / his responsibility
- Report on a weekly basis the progress of work including any pending items and deadlines.
- Be fully aware of specifications, drawings, work procedures and ensure the contractors receive the adequate documentation and training to perform the work correctly
- Perform change control assessments as per defined standards and procedures in place
- Ensure the change management system is applied correctly and confirm that prior to execution of any additional /extra work caused by scope changes, the proper authorization is obtained
- Plan that relevant inspections and tests are performed in compliance with the Project standards or legal requirements
- Participate, issue, revise and/or approve commissioning & qualification related documentation (i.e.: Protocols, Test Datasheets, Instrument Impact Assessment, Reports, etc.)
- To coordinate commissioning and/or qualification related activities with involved areas
- When applicable, lead the external qualification contractors assuring the optimal use of their time/cost.
- Perform preparation of the commissioning and qualification activities in coordination with the involved areas (design engineering, assembly, automation, user area, QC and QAU) according to the defined standard and procedures in place
- Guarantee the delivering of commissioned & qualified facilities that can meet user and technical requirements.
- Perform deviation investigations and CAPA implementation as per applicable procedures in place
- On hand-over, guarantee that deliverables were fully commissioned and qualified, when applicable, and are meeting user requirements, cGMP guidelines, internal procedures and customer expectations
- Promote a list of pending items with responsibilities and deadlines (punch list) that do not infringe installation compliance with cGMP and HSE guidelines
- Support the training of the end user to ensure they make best use of the equipment
- Register the user feedback for future learnings
- Apply and develop knowledge of Engineering and participate in area processes, procedures and projects with the guidance of more senior colleagues
- Ensure all assigned tasks are planned and delivered on time, safely, efficiently, reliably and in a cost-effective manner
- Guarantee the compliance to safety and legal rules on the field, coaching all resources involved and liaise with authorities whenever necessary
- Participates in audits performed by clients and health authorities, in the scope of the Qualification and Validation area
- 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, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others).
Actively contribute to managing profitability through the deployment of controlling best practices across the company. Responsible for the timely, accurate, and insightful analysis and reporting of financial information to key stakeholders. Drives the long-term financial planning of the company, including the investment program.
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- Supports Business Segment Leadership and Global Sales in achieving its operative and strategic goals
- Financial support at acquisition of large CDMO projects
- Analyze and assess of strategy, business development, and business opportunities and risks of the Business
- Support for essential control processes (such as creation of the specified goals for mid-range planning, reporting)
- Participation in the continued development of the strategy
- Economic assessment of investments and portfolio measures
- Preparation of decision recommendations for the Company Management
- Support for and assessment of market / competition analyses
- Participate in Global Automation projects, supporting the implementation of new or upgraded systems and their lifecycle
- Develop and maintain system standards
- Incorporate new solutions for digital innovation
- Introduce or propose new objectives to have a continuous improvement
- Collaborate and support site automation; promoting proven best practices and standards
- Maintain and develop standards, procedures and specifications for systems hardware, software, interfaces, and data acquisition in compliance with internal and external guidelines
- Define system architecture and infrastructure requirements
- Define system interface and integration standards
- Develop and review specifications, testing document templates, as well as internal and standard operating procedures (IOP, SOP)
- Collaborate with site Automation to support exchange proven practices and standards
- Collaborate on internal / external audits and inspections
- Follow HSE program, participate in PHA, FMEA and HAZOP
- 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)
Delivers win-win cost-effective solutions on time and in full through a Team of Project managers leading 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. Enable and coach the Project Managers 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.
Main responsibilities:
- Lead the development of the Project Management area vision, strategy and measures, ensuring these are aligned to the overall business, in collaboration with the PMO Director.
- Develop and sustain standardized PM processes, implemented in a consistent and repeatable manner.
- Oversee the integration of program and project processes
- Develop organizational governance frameworks, hierarchies, and relationships
- Monitor portfolio, program, and project performance (actual versus planned) and key performance indicators.
- Implement a PM continuous improvement system, to optimize the existing processes and adapt to new challenges and realities, in the line with the overall Corporate PMO strategy
- Facilitate organization-wide stakeholder engagement and agreement, actively contributing to customer satisfaction
- Control area deliverables and ensures they are completed on time and in full and within budget, thereby exceeding customer expectations
- Assign program and project managers to programs and projects
- Manage 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 approval the short and mid-term goals, annual budget and budget plan in line with the corporate strategy, in order to align activities with Hovione strategic objectives
- Prepare and propose for superior approval the annual area 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.
- Active member of the site leadership team influencing the strategic direction of the site and bringing the customers’ perspective to the attention of the SLT
- 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) within his/ her TMs
Perform qualitative and quantitative analyses of compounds, including drug substances, drug product intermediates and drug product. Recommend the analytical characterization package (Chemical, physical, performance) and control the quality and accuracy of the data in compliance with legislation and regulatory standards of Quality, HSE and cGMP policies. Promote 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.
- 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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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.
- Plan, coordinate and supervise the work, with other managers of the area, and manage own team 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)
- Assure that all TMs of the team have suitable training in order to guarantee the best possible support to the customer (internal and external)
- Ensure an appropriate information flow between the laboratory and the several internal and external customers
- Participate in external and internal audits
- Approve analytical test methods, reports, protocols and other documents related to the laboratory (as applicable)
- Approve raw material, intermediate and finished product batches, stability samples, validations and/or all samples sent for QC to perform analysis
- Approve In Process and COL samples when necessary
- Assure the availability of International standards and Hovione internal working standards with adequate calibrations/qualifications
- Manage International/In-house Primary and Secondary/Clients' standards and reserve/retention samples
- Assure the qualification of the laboratory equipment and validation of analytical methods, approving the protocols and / or respective reports
- Discuss and propose specifications for raw materials, and intermediate and finished products
- Ensure proper management of all defined stability programs in terms of protocol preparation, inventory management, analytical testing execution and data release
- Ensure that corrective and preventative actions are defined and implemented as a result of deviations occurred in the Area, and of internal and external audits
- Keep up to date on new analysis techniques relevant to the laboratory, by means of literature, training, seminars or conferences
- Assure the timely execution of the preventive maintenance program and execution of corrective maintenance.
- 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.
- As subject matter expert you will lead multiple pharmaceutical development projects to ensure effective collaboration between internal & external stakeholders to meet the objectives of Hovione and our clients.
- Developing drug product manufacturing processes for oral drug products, including scale up, technology transfer and design space definition.
- Promote innovation by identifying, evaluating, and recommending new technologies and/or methodologies for Hovione.
- Strive to maintain Hovione as specialists in the field of Oral Drug Product Development through patents and scientific papers.
- Keep up to date with current global trends in the pharmaceutical industry, using this information to identify areas for improvement and opportunities for growth/investments.
- Select, evaluate, and make recommendations for new equipment to ensure practices and methodologies are aligned with state-of-the-art for pharmaceutical development.
- Create a knowledge sharing environment by mentoring the wider team in their experiments and by expanding their technical/theoretical knowledge and experience.
- Lead to the development of new products and services for Hovione and/or for our client base. It may result in ownership of intellectual property such as patents. It is the key driving force of innovation and science in the organization, managing new ideas and innovation across the company.
- 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.
- Be a liaison between the Assessment Group and the client when discussing the scope of work of analytical projects. This includes Technology Transfer Centre (TTC) projects and projects from other sites where his/her input is considered relevant. 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.
- Work as an advisor for analytical challenges that take place in the global CRD organization.
- Be the analytical contact for all the projects run in the TTC. Participate in team meetings and actively suggest analytical improvements to the work that is required or delivered to a particular client.
- Develop new analytical methods that are scientifically sound for the different projects run in the technical transfer.
- Be a scientific leader in investigations of deviations incurred in the analytical area.
- Support and mentor analytical community at the TTC and CRD and help develop their capabilities, particularly of any direct reports under his/her supervision.
- Work closely with the R&D, QC and QA groups in order to assure that the analytical work done is the most appropriate for the chemistry at each stage of development.
- Promote compliance on Health, Safety and Environment in the area and activities.
