I am partnering with an exciting biotech start up, who aim to provide best in class medical skin care and therapeutics against dermatologic diseases. Being based and targeting US and German markets, they are looking for a new team member to become part of an enthusiastic team of scientists and drive CMC strategy and hands on activities forward.

Are you looking to join a start up where you can truly impact the business and help it grow?

Do you want to embark on an exciting journey building activities and in the near future a team around you from scratch?

Director CMC - Drug Product - Small molecules - Project Management

Your responsibilities:

• Lead and manage CMC activities, execute CMC strategy for pipeline products on global level
• Report directly into the CEO and work closely cross-functional teams
• Support a transfer of drug candidates (clinical stage) into final drug product
• Building up relationship and coordinating CMOs, acting as a key POC
• Ensure drug product development, scale-up and DP manufacturing, APIs vendors selection
• Working with global authorities (mainly FDA)
• Review and author CMC documentations, SOPs - GMP compliant
• Be involved into the design and management of lab experiments for the preformulation and formulation development, plus process development
• Act as a sole SME for CMC

Your profile:

• Masters or PhD degree in chemistry, biochemistry or pharmacy
• at least 8-10 years of industrial experience in Drug Product development and CMC project management, good knowledge of FDA and GMP is a must
• Hands on experience in reviewing and analyzing CMC sections for IND, IMPDs and NDAs, experience working with CMC submissions, BLA/MAAs
• Experience working with and coordinating CDMOs/CMOs is a benefit
• Strong project management skills and affinity to hands on activities, being in a matrix start up environment
• English is a Must, German is a plus

Location: Heidelberg, Germany, with an opportunity to work in hybrid model (home/remote combined)! 

---> Reach out! Alina.Begisheva@peoplewithchemistry.com