CHEMISTRY, MANUFACTURING, AND CONTROLS DOSSIER DEVELOPMENT COORDINAT...

Job description

Sanofi is a global healthcare leader focused on patients' needs, engaged in the research, development, manufacturing and marketing of therapeutic solutions focused on patients’ needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets and Sanofi Genzyme.
Program SaVIE (VIE of Sanofi) is available to citizens of the European Economic Area (EU + Norway, Liechtenstein and Iceland) aged between 18 and 28. PLEASE NOTE since the VIE Program is primarily an international development program, candidates cannot apply to a VIE assignment in their own country of citizenship.
Only applications that are submitted in English will be considered.
The CMC Dossier Development and Coordination (CDDC) department within the Sanofi R&D Scientific Core Platforms (SCP) organization has the broadly defined roles and responsibilities for the development, coordination and delivery of high-quality CMC dossiers in a timely manner for all small and large molecule based pharmaceutical and biopharmaceutical products from First in Human clinical studies to Market Authorization Applications.
The CDDC department consists of a team of scientists who possess in-depth product development experience and expertise and are well versed with the CMC dossier regulatory requirements and expectations. Fully embedded within the product development organization, it provides the expertise and guidance to all aspects of CMC dossiers throughout the product development cycles.
JOB PROFILE:
The person on this position coordinates and supports project related dossier activities in accordance with the timelines of the project as well as strategies and policies. Will provide scientific guidance to the scientists and other associates of the team and will represent CMC Dossier Development and Coordination as a member of the integrated CMC Team for biopharmaceutical modalities (proteins/ peptides).
Examples of CMC dossier deliverables include but are not limited to:
o IND/IMPD/CTA clinical study applications
o NDA/BLA/MAA market authorization applications (eCTD Module 3 & Module 2 Quality Overall Summary)
o Briefing packages for major product development milestone regulatory agency meetings and written responses to CMC related questions from global Health Authorities
o CMC Parts of Clinical Investigator´s Brochures (CIBs), Pediatric Investigational Plans (PIPs) and Drug Abuse Liability Assessment (DALA)
o Attend agency meetings as needed
PRINCIPAL DUTIES AND RESPONSIBILITIES:
Briefly describe the major duties and responsibilities for which the job is held accountable (please rank in order of importance.)
MAJOR DUTIES & RESPONSIBILITIES :
1. Leads CMC dossier subgroups and CTD CMC satellite groups to ensure high quality and timely deliverables on projects according to plan in collaboration with partners
2. Builds and strengthens relationships with partners, e.g, Regulatory, IA, SQO and REGN.
3. Proactively alerts LT re. CMC problems w.r.t. dossier content before they become issues.
4. Communicate lessons learned from submissions.
CANDIDATE'S PROFILE:
Minimum requirements for assignment to the job:
Track Record :
- Worked in pharmaceutical development organizations with expertise in CMC development and registration or within health authorities with similar expertise and demonstrated accomplishments in drug product development and CMC filings.
- CMC dossiers fluency having delivered successfully CMC dossiers, preferably including BLAs / as well as projects in R&D
- Regulatory working knowledge from operational and project perspective (submissions, inspections, approvals), for new chemical entities, mAbs, vaccines and/or devices.
- Strength and experience in quality aspects
- Superior understanding of entire R&D processes and state-of-the-art approaches in the development / CMC area, including current regulatory requirements (ICH, Quality by Design, Drug Device Combination products)
- Scientific credentials including conference presentations, academic publications in professional journals and/or patent applications issued
- International experience (international assignments and/or multinational projects & teams)
- Good technical understanding and insight for document management systems, publishing and e-submission requirements.
Social & Emotional Excellence:
- Integrity, excellent networker (lead cross-functional CMC teams), very good analytical and negotiation skills
- Mindset committed to high quality
- Excellent communication and presentation skills
- Ability to anticipate, prevent and resolve CMC problems.
- Ability to work under significant time pressure (e.g. for agency response activities) with partners in R&D departments, Industrial Affairs, Regulatory.
- Ability to handle multiple project responsibilities and to adjust to changing priorities.
- Present conflict-solving skills
Formal Education And/Or Experience Required:
- Ph.
D. / Sc.
D with background in biologics, chemistry/ biochemistry development and/or analytics
- 5 or more years R&D CMC development experience within pharmaceutical /biotech industry and/ or Health authorities.
- Expertise and experience in one or more of the following are a MUST: bio-development including process development, analytical development and/or formulation development and/or GMP bio-manufacturing.
- Knowledge and experience in CMC dossiers, regulatory CMC and operations and compliance
Knowledge And Skills Desirable But Not Essential:
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