We are looking for a seasoned professional with strong Analytical Development experience of Pharmaceutical Products to join our Montpellier, France facility and participate in our on-going success as a financially sound, fast-growing, socially responsible company dedicated to Global Health.
As the Senior Analytical Development Leader, you will work collaboratively within the cross-functional Product Development and Supply (PDS) Teams to ensure global analytical strategies are developed and executed, enabling successful progress of our projects through development and filing of CMC dossiers with Health Authorities. Programs will be in various stages of development, with complex international activities, compliance requirements and regulatory scenarios. Your scope will include all stages of development from Lead Formulation Selection to Clinical Phases and global submissions (INDs, IMPDs, NDAs, BLAs, MAAs).
Reporting to the Head of Technical and Pharmaceutical Operations (TPO), Leadership in Drug-Product Development (DPDE), Non-clinical, Regulatory and Clinical Teams consultants. You will also ensure that the company is aware of and responsive to external guidelines, changes in EHS, Compliance and Regulatory requirements.
Analytical Development Strategy
• Define the strategic analytical pathways and plans at each development step in close alignment with the Drug Product Development (DPDE), Non-Clinical Development and Regulatory Teams.
• Support and coach the different Analytical Lab Leaders within the Analytical Development Department with his / her expertise and leadership (design, review and approval of documents)
• Ensure that the operational process for Analytical Development, ICH Stability Studies and QC Testing is standardized with the company Standard Operating Procedures (SOPs) and help improve current SOPs.
• Build and maintain a strong Analytical Development Team and a network of external collaborators and consulting experts for analytical techniques and competencies not available internally.
• Support the TPO Continuous Improvement Roadmap implementation, to get recognition as Analytical Center of Expertise for MedinCell and external partners.
Analytical Development Leadership
Develop and put in place best-in-class Analytical Development Practices and Team:
- Incorporate expert knowledge and advice, scientific and regulatory considerations, and strategic business needs in the design and implementation of Analytical Development Plans
- Define and implement Analytical Development work plans including objectives, milestones and deliverables
Providing leadership in MedinCell in the planning and execution of the Analytical Method (AM) CMC parts of regulatory dossiers (IND, IMPD, NDA, MAA, etc …):
- Collect analytical needs from DPDE Teams (API, DP)
- Develop fit-for-purpose AM for all development steps, from Lead Formulation Selection to Clinical Phases (Phase 1 to Phase 3)
- Develop, validate, transfer AM to the DPDE Units and monitor their potential changes (change control, risk assessment, CAPA plans, etc…) during life cycle in the Units for DPDE activities
- Perform AM validation with appropriate validation level at each stage of the projects (Lead Formulation Selection, Non-Clin. Dev., Phase 1 to Phase 3)
- Perform (in-house) and/or monitor (at contractors) ICH Stability studies
- Perform (in-house) and/or monitor (at contractors) Analytical QC of GMP in-coming materials, GMP DP batches at each level of Clinical Development stage
- Develop and implement Quality by Design (QbD) approach for AM Development
- Lead transfer of AM to manufacturing sites and development partners
- Lead preparation, review, and collection of AM Development documentation for regulatory submissions (CMC Parts of the dossiers, e.g. 3.P2, etc…); provide critical review of all AM Development documentation supporting regulatory applications, including AM Validation, Stability Studies and Plans, DP Specifications, Shelf Life Allocation, in collaboration with Regulatory Affairs and Quality Departments
- Provide AM data packages to development partners for preparation of their own submissions
Serve as a cross-functional leader and senior subject matter expert in Analytical Development
- Develop deep knowledge of our product portfolio
- Maintain updated knowledge of current global guidelines and regulatory requirements governing drugs and biologics analytics and characterization in all phases of development
- Lead Analytical Development involvement in related projects and variations, e.g. transfer, scale-up and process changes at manufacturing sites, specifications changes, process changes, etc.
- Support Business Development activities
- Serve as lead Analytical Development reviewer in due diligence for in-licensing opportunities
• Recruit best talents for the Analytical Development Centre of Expertise (ACE) Team
• Manage a team of up to 20 people working in the Analytical Development Department and secure smooth relationships across the organization to ensure efficacy
• Develop project orientation of the ACE Team in a matrix-based organization and allocate an appropriate ACE representative to each Project Development & Supply (PDS) Team.
• Build, mentor, empower and develop a highly skilled team of professionals and instill high performance standards
• Promote values of the Company within the ACE Team
• Instill customer-orientation culture to the Analytical Development team to find appropriate solutions for implementation of Company strategy
• Minimum eight (8) years of experience in Analytical Development in Pharmaceutical Industry with a significant experience in injectable Pharmaceutical Products
• Ideally Pharm D or Engineer degree with a PhD in Chemistry, Pharmaceutical Science, Analytical Sciences, …
• Strong hands-on experience in all phases of Pharmaceutical Development from Early Stage to approvals and Post-Marketing variations
• Experience in working in pharmaceutical development partnerships such as co-development agreements
• Expert knowledge of drug development processes and regulations, especially for injectable Pharmaceutical Products
• Experience in polymer-based drug delivery systems (DDS) is a plus
Knowledge, skills and abilities
Analytical Development skills:
- Ability to define Analytical Development strategy and generate high quality documentation (protocols, reports)
- Strong proficiency and abilities in preparing CMC parts of the regulatory dossiers and answering questions of Regulatory Authorities for various markets
- Strong knowledge and practical experience in implementing GxP guidelines and regulatory requirements for various markets (FDA, EMA, RoW), especially for injectable Pharmaceutical Products
Leadership, organizational, and problem-solving skills:
- Ability to mentor and coach colleagues to successfully achieve objectives
- Ability to accurately estimate time for specific tasks
- Ability to plan sequential and / or concurrent activities
- Ability to develop and manage budgets
- Ability to determine priorities within project plan
- Ability to manage multiple priorities with tight deadlines
- Ability to anticipate and resolve issues on a daily basis
- Ability to work effectively across multiple project teams in a matrix environment to reach overall business goals
- Ability to work in a diverse environment with different stakeholders
Strong interpersonal skills for:
- Effectively listening to customers to collect their needs (PDS Teams, Assessment Teams, Contractors, Regulatory Affairs, Agencies, etc…)
- Managing relationships and communication exchanges internally and with co-development or manufacturing partners
- Effectively leading meetings internally and with third-parties in English
- Effective international collaboration
- Fluency in speaking and writing English
- Good understanding of spoken and written French
- Demonstrated ability to produce high quality written documents that effectively communicate in a clear, organized and concise manner
- Highly collaborative cross-functional approach
- Results orientation with focus on timely delivery and sense of urgency
- Effective functioning in a rapidly evolving environment and adherence to the values, principles and mission of the company
- High degree of autonomy
- Strong listening skills
- Openness and ability to adapt to changing situations
- Active involvement in Continuous Improvement
- Strong work ethic