Senior Director, Drug Substance Manufacturing
About The Position
Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients. We are collaborative, creative, and experienced professionals and we’re looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously. We are looking for a Senior Director of Drug Substance Manufacturing, Biologics who is upbeat, organized, self-motivated, collaborative, detail oriented, has a strong technical background and knowledge base. The role requires being able to support and prioritize to meet both short-term and long-term goals. This is a fantastic opportunity to make an impact, wear many hats, and be a part of an exciting growing biotech company. This position is located in Foster City.
Requirements
- Bachelor’s degree or higher.
- At least 15+ years of work experience in the pharmaceutical/biotech industry with extensive experience in biologics drug substance manufacturing and tech transfers.
- Experience managing relationships with biologics CDMOs
- Working knowledge of US and European cGMP guidelines and requirements.
- Experience in technical writing in support of regulatory submissions
- Able to effectively communicate updates, issues, and strategic solutions to problems.
- Strong technical and interpersonal skills; able to lead through influence.
- Exceptional verbal and written communication skills.
- Strategic, able to identify long term needs and risks and to incorporate these into a long term plan
- Excellent organizational skills: ability to multitask and manage timelines.
- Detail oriented while able to see “big picture”
- Assertive, pro-active, professional, and confident.
- Willing to travel and to participate in teleconferences during non-business hours.
Responsibilities
- Serve as Tech Transfer Leader for the transfer and scale-up of the brelovitug (monoclonal antibody) drug substance process to ensure continued commercial supply. Includes leading a cross-functional internal team and serving as the primary contact to the CDMO.
- Oversee business and finance aspects of the transfer including management of budget for all related transfer activities from project initiation through production of PPQs.
- Provide oversight of commercial brelovitug drug substance manufacturing, including reviewing batch records, reports, and trending process performance
- Identify opportunities for process improvement that increase productivity
- Co-author and review regulatory documents pertaining to the transfer, including Prior Approval Supplements. Serve as SME during meetings with Health Authorities and during inspections at the CDMO, as needed.
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What This Job Offers
Job Type
Full-time
Career Level
Director
Number of Employees
101-250 employees
