Research and Development Manager
vor 1 Woche
As Aptissen continues to grow we are seeking for a dynamic and experienced **Research and Development Manager **to join our team.
This newly created internal position involves designing activities from scratch (Greenfield). The R&D Manager will lead, innovate, and drive Aptissen’s R&D and Clinical program to support our orthobiological transformation and enhance our active products/solutions portfolio.
These activities include:
- To lead the Design and development process cycle including sequential design stages and phases: Concept development, Design and Development, Verification and Validation, Design Changes, planning, Inputs, Outputs, budget and support in Life Cycle and Post-Market.
- Risk Management
- Intellectual Property management.
- To manage and support the team in charge of clinical operations activities.
- As R&D expert, you will master and offer technologies to deliver next-generation concepts for life-changing medical devices to patients and clinicians.
**KEY TASKS & RESPONSIBILITIES**
- Managerial _
- Coach the R&D and Clinical Project Manager
- Supervise the department: set goals and objectives in line with company objectives and provide guidance, mentoring, and staff development tor the team to meet current and future business needs.
- Represent R&D/Clinical topics during audits by regulatory agencies/Notify body.
- Design and Development_
- Propose a framework for elevating the New Product Development process.
- Lead the initial Product design phases, collaborating with Sciences and Technology, QA and RA, Medical and Marketing department(s).
- Ensure timely execution of R&D/Clinical activities within our CROs/CDMOs, in compliance with cGMP, legal and regulatory requirements, and the Corporate Quality Manual and Policies.
- Oversee R&D partnerships.
- Oversee the development of analytical methods for cleaning and process validation ofinjectable products (MD / Drugs).
- Supervise analytical techniques, interpretations of analytical data, problem-solving, and troubleshooting as required for R&D approval.
- Prepare SOPs, guidance, protocols, monographs, reports supporting laboratory GMP function in compliance with EU, FDA, ANVISA, ICH, and other regulatory guidance.
- Oversee formulation, concept and feasibility analysis required for R&D approval.
- Work closely with the QA and RA departments to prepare SOPs, guidance, protocols, technical documentation (DHF, DMR, design & development plan, URS, FRS, Risk Analysis, Clinical Evaluation ), and reports supporting technical documentation in compliance with regulatory guidance.
- Maintain up to date knowledge of health authority requirements, trends, technologies, processes, and systems. Provide input to health authority requests.
- Lead supportive processes such as Risk Analysis, Robustness, Technical documentation, and expertise for post Market Surveillance.
- Lead and support local and global projects.
- Risk Management_
- Develop and execute the Risk Management strategy
- Ensure timely execution of Risk Management for Medical Devices/Drugs in compliance with cGMP, legal and regulatory requirements, and the Corporate Quality Manual and Policies.
- Lead the risk management process, including Strategy/Guidelines, Risk Analysis, Risk Evaluation, Risk controls and Risk Management review.
- Intellectual Property management_
- Ensure partnership with lawyers to ensure protection in compliance with Aptissen IP Strategy.
- Collect data and prepare technical description of technologies for third-party for IP risk assessments or for patent oppositions.
- Clinical Operations activities (with the team)_
- Oversee all clinical operations activities: from set-up to study closing.
- Ensure partnerships with CROs.
- Participate in the evaluation of new products.
- Participate in the design documentation and provide project management support for new product development.
- Perform document sponsor oversight.
- Participate in pre-clinical phases (BEP, BER), clinical evaluation (CEP, CER)
- Maintain a competent knowledge of applicable Policies, Guidelines, SOPs, conventions, tools, templates and instructions, including current Good Clinical Practice (GCP) and applicable local regulations related to the conduct of clinical trials.
- Assist in the set-up and management of clinical trial supplies.
- Budget_
- Responsible for the team budget preparation and ensure that the approved budget is met.
**EDUCATION/LANGUAGES**
- Sciences/Chemical/Pharmaceutical Engineering, Pharmacist, Master’s degree in chemistry, Biology, Biochemistry, Pharmaceutical Sciences or related field
- French (native/fluent)
- Fluency in English
**PROFESSIONAL SKILLS & EXPERIENCE**
- Min of 10+ years of experience in R&D within pharmaceutical industry and/or Medical devices
- Experience in working with external CROs and CDMOs
- Advanced knowledge of Development of analytical methods
- Advanced experience in development MD/Drugs (injectables) manufacturing processes / formulation
- Stron
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