Senior Director, Drug Substance Manufacturing - Mirum Pharmaceuticals

POSITION SUMMARY

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.

PRIMARY 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.

QUALIFICATIONS

• 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.

KNOWLEDGE, SKILLS, AND ABILITIES

• 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.

The salary range for this position is $270,000 to $290,000 USD. Compensation will be determined based on several factors including, but not limited to; skill set, years of experience, and the employee’s geographic location. Please note that the required compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits unless otherwise provided.

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