EnglishBiopharma Company in the south of Sweden
Senior Director CMC
Job Title: Senior Director, CMC and external Manufacturing
Position Summary
The Senior Director, CMC will lead a team of scientists and engineers responsible for biologics drug substance and drug product process development and manufacturing. This individual will play a key leadership role in driving CMC strategy and execution across all phases of development, ensuring the timely delivery of high-quality clinical and commercial materials in compliance with regulatory and quality standards.
Key Responsibilities
• Provide strategic and operational leadership for drug substance and drug product process development, analytical development, scale-up, technology transfer, and GMP manufacturing activities.
• Lead and mentor a team of scientists and engineers to drive innovative solutions and operational excellence
• Oversee development and implementation of robust, scalable, and cost-effective manufacturing processes for clinical and commercial supply of biopharmaceuticals according to GMP.
• Manage external manufacturing partners (CDMOs/CMOs), ensuring alignment with program objectives, timelines, budgets, and quality expectations.
• Partner cross-functionally with Regulatory, Quality, Clinical, and Project Management to support IND, IMPD, BLA/NDA filings and other regulatory submissions and inspections.
• Represent CMC during Due diligences and internal/external Audits
• Develop and manage CMC development plans, timelines, and budgets.
• Establish and maintain strong relationships with internal and external stakeholders to ensure seamless execution of CMC strategies.
• Drive continuous improvement initiatives and incorporate emerging technologies to enhance development and manufacturing capabilities.
• Drive and lead contract negotiations e.g MSA, CSA with suppliers for clinical and commercial products
Qualifications
• Advanced degree (Ph.D. or M.S.) in Chemical Engineering, Chemistry, Biochemistry, Pharmaceutical Sciences, or related discipline.
• 12+ years of relevant biopharmaceutical industry experience, including significant leadership roles in CMC process development and manufacturing of biologics.
• Proven track record of leading teams responsible for drug substance and drug product development, scale-up, and manufacturing for clinical and commercial stages.
• Comprehensive knowledge of the interplay between manufacturing processes and product quality of biopharmaceuticals, along with the corresponding control strategies. Strong experience managing external partners and CDMOs/CMOs.
• Deep understanding of regulatory requirements (FDA, EMA, ICH) related to CMC development and manufacturing.
• Excellent leadership, communication, and interpersonal skills with the ability to influence across functions and levels.
• Strategic thinker with strong problem-solving skills and a hands-on, execution-oriented mindset.
Contact
For inquires and more information about the position, please contact:
Catharina Herbertsson or Eva Runnerström, Senior Recruitment consultants at PeakSearch.
E: catharina.herbertsson@peaksearch.se
M: +46 706 152 772
E: eva.runnerstrom@peaksearch.se
M: +46 701 725 379
Application
Apply for the position at www.peaksearch.se and/or send your CV with a cover letter to one of the above addresses.