Outsourced CMC activities Project Manager
Outsourced CMC activities Project Manager
Paris

Full Time

POSITION FILLED

LinKinVax is developing a unique and innovative vaccine platform that accelerates the availability of safe, effective and scalable vaccines, based on the work of the VRI (Vaccine Research Institute), a French laboratory of excellence created in 2011. This vaccine platform called DC Targeting is universal, and adaptable to the evolutions and mutations of the target pathogens.

Five vaccines will be proposed to the market within five years, including a vaccine already in clinical trial on HIV in 2021, and two vaccines which will be in clinical phase in 2022 (SARS-CoV-2, HPV-related cancer). On the other hand, LinKinVax supports upstream research to be able to adapt its platform to new pathogens.

Resulting from the association of leading French scientists and entrepreneurs, LinKinVax benefits from a portfolio of 13 patent families extended internationally and from a close partnership with the VRI laboratory of excellence.

For more information, please visit https://:www.linkinvax.com

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Mission

Under the responsibility of the Director of CMC activities, you will be integrated to the project management team of Manufacturing and Controls activities in support of development of the drug products of LinKinVax within a completely outsourced environment. 

You will contribute by your operational expertise to ensure the effective and efficient delivery of all operational aspects of one or more CMC activities program through all phases of the drug development in accordance with the appropriate quality standards including ICH/GMP and applicable regulations. The suitable candidate achieves this by delivering high quality study management support and other high value services to enable team and project success.

You will

  • Manage early to late-stage drug product development and validation for multiple programs in a 100% out-sourced environment by a close interaction with CDMOs that manufactured the LinKinVax products 
  • coordinate development and optimization of Drug Product manufacturing, controls and formulation by acting as technical interface to guide CRO/CDMO to design formulation and manufacture of drug product
  • Provide technical expertise input on USP, DSP, analytical methods and formulation development and / or process and methods validation strategies to develop phase-appropriate drug product for preclinical, clinical and future commercial use
  • Participate in the process of identification, qualification, selection and contracting out with CDMO for Drug Product development and manufacturing according to specific project needs
  • Interfaces with project team and with external suppliers as necessary to plan and coordinate the timely execution of CMC activities
  • Participate to coordination of  drug supply activities for Phase I to III clinical trials
  • Contribute by Author/review drug product development reports and related sections in regulatory documents (IMPD, IND, NDA…) in interaction with LinKinvax Regulatory affairs team in accordance with LinLinVax policy.
  • Participate to the interactions with regulatory authorities (e.g. FDA / EMA meetings)
  • Participate to ensure consistency, completeness, accuracy, and adherence to regulations and applicable guidelines (ICH, GMP…)
  • Ensure the execution of drug development project strategies and operational plans that integrate the CMC development strategies and operational plans with those of other functions in order to expedite successful product development, regulatory approvals
Job profile
  • Pharmacist or Advanced degree in scientific discipline with ideally at least 5 years of experience in the pharmaceutical industry or a CDMO
  • Expertise in development of innovative products (vaccine or antibodies), technology transfer, process optimization and validation
  • Strong understanding of the drug supply, distribution and packaging process
  • Track record of success in leading recombinant protein and / or antibody-based drug product programs in a 100% outsourced biotech environment
  • Thorough knowledge of the drug development process and sound understanding of CMC regulatory requirements
  • Direct experience with compiling CMC sections for INDs/IMPD and responding to regulatory queries
  • Experience with regulatory interactions and inspections
  • Demonstrated ability to work with teams in a culturally diverse, complex, changing environment
  • Effective problem solving and analytical skills to tackle a broad range of issues and projects and deliver innovative solutions
  • Excellent Microsoft Office applications skills
  • Excellent oral and written communication skills which enable successful collaboration with executive stakeholders internally and externally
  • Fluent in English
  • Ability to Interact on a regular basis with international CDMOs in France, Europe and in USA, meaning with meetings starting or ending late for French citizens. 
  • Ability to travel
  • Flexibility
  • Possibility to work partly at Home office (3days on site / 2 days home office)