Associate Director Chemistry and Manufacturing

Location Leiden, Netherlands
Discipline: Biotechnology
Job type: Permanent
Contact name: Ramon Sena

Contact email:
Job ref: 10746
Published: 19 days ago

Roles and Responsibilities:

• Manage DS manufacturing activities at The Company and at drug substance CDMOs. Interact with contract site management and staff (may include being on site)

• Manage the manufacture of drug substance for toxicology studies, clinical trials, and commercial supply at CDMOs, including review and approval of GMP documentation:

 - Process development and/or process transfer

 - Change documentation

 - Master and executed DS batch records

 - Proactively manage risks and develops mitigation plans. Identify and communicate risks and issues that impact quality, compliance or project timelines.

• Prepare requests for proposals (RFPs) and technical packages for the procurement of GMP DS manufacturing campaigns

• Provide support and guidance to the analytical development and quality control (AD/QC) team in the development of appropriate analytical testing methods

• Proactively identify ways in which research and manufacturing objectives can be achieved on expedited timelines while advancing multiple risk mitigation strategies in parallel

• Work with QA and QC to prepare drug substance release and stability specifications and provide technical guidance for on-site audits

• Interpret and summarize complex data and serve as the primary author and lead writer of technical documents, development reports, and DS CMC sections for IND, IMPD and global marketing applications with minimal supervision.


We expect our Associate Director to have: 


• Ph.D. in organic chemistry or related discipline with 5+ years of experience, or Master’s with 8 years of experience, or a Bachelor’s degree with 10+ years pharmaceutical industry experience.

• Excellent scientific knowledge of process chemistry and preferably experience in oligonucleotide manufacturing (or solid phase synthesis in general)

• Prior manufacturing experience, including management of CDMOs, development of manufacturing processes and experience with good manufacturing practices for the preparation of drug substance for clinical studies and commercial supply

• Experience in drafting DS CMC sections (ICH CTD M3 format) of INDs, IMPDs, and/or marketing applications, and practiced in responding to inquiries from regulatory agency review

• Demonstrable knowledge of regulatory guidelines (FDA, EMA, ICH)

• Strong written and oral communication skills

• Team player with demonstrated ability to work well with other professionals within and across functions/teams

• Ability to multi-task and shift priorities rapidly to meet tight or changing deadlines

• Detail oriented and well organized.