CMC Lead - Diamyd, Stockholm/Mälardalen

On behalf of Diamyd Medical we are looking for an experienced, communicative and proactive CMC Lead to their R&D department. 

Diamyd Medical develops precision medicine therapies for the prevention and treatment of Type 1 Diabetes and LADA (Latent Autoimmune Diabetes in Adults). Diamyd^® is an antigen-specific immunomodulatory therapeutic for the preservation of endogenous insulin production that has been granted Orphan Drug Designation in the U.S. as well as Fast Track Designation by the U.S. FDA for the treatment of Stage 1, 2 and 3 Type 1 Diabetes.

A biomanufacturing facility is under development in Umeå, Sweden, for the manufacture of recombinant GAD65 protein, the active ingredient in the antigen-specific immunotherapy Diamyd^®. Diamyd Medical’s B-share is traded on Nasdaq First North Growth Market under the ticker DMYD B.

As CMC Lead you will work in a cross functional team planning and executing activities ensuring the successful preparation of our product for commercial manufacturing and regulatory approval.

The office is based in Stockholm City and you will report to the Chief Scientific Officer. Hybrid working solution is possible.

Key Responsibilities:

• Lead CMC DP activities by taking charge of all activities related to the drug product to ensure readiness for BLA/MAA submission, including development, manufacturing, and regulatory documentation

• Develop, implement, and manage the strategy and timelines for DP development in collaboration with cross-functional teams

• Lead and manage key CMC projects, primarily DP-related but potentially including other areas within the CMC scope

• Work closely with Diamyd manufacturing site, CMOs and CROs to ensure smooth and efficient production and testing of the drug product including budget control

• Oversee manufacturing processes and analytical methods, ensuring alignment with industry standards and regulatory requirements

• Provide support and guidance to the Pharmaceutical Development Manager

• Become an expert on our product, understanding all technical, regulatory, and development requirements for successful regulatory submissions

• Take responsibility for the regulatory documentation (Module 3) related to DP, ensuring timely and accurate submissions

Qualifications:

• MSc/PhD within a Life science related field

• At least 10 years of working experience in CMC within the pharmaceutical/biotech/CRO industry

• Knowledge with regulatory requirements of biologics DP/DS for BLA/MAA

• Proven experience writing technical documentation for EMA and FDA

• Solid understanding of sterile product manufacturing (injectables)

• Strong project management skills with a demonstrated ability to lead cross-functional teams

If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you.

Welcome to apply via haegercarlsson.com

Questions are answered by:

Lena Sörskog +46 (0)70-692 4570, [email protected]

Anna Freese +46(0)76-174 7581, [email protected]