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Senior Manager, CMC Drug Substance Manufacture

Foster City

 

MISSION

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.

 

POSITION SUMMARY

We are looking for a Senior Manager of API/Drug Substance 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

  • Support drug substance development and manufacturing function within a small dynamic team for multiple programs.
  • Support the tech transfer and production for late-stage supply.
  • Help manage the supply chain for regulatory starting materials and drug substance supporting clinical trials through commercialization.
  • Support development activities such as, process optimization, manufacturing, and validation.
  • Review production documentation and reports.
  • Support regulatory document submission to help the filing of INDs, IMPDs, NDA and MAA submissions.

QUALIFICATIONS

  • Bachelor’s degree or higher.
  • At least 5-10 years of work experience in the pharmaceutical/biotech industry with experience in API/drug substance manufacturing with small molecules.
  • Experience working, collaborating with and managing, selected CMO’s
  • Working knowledge of US and European cGMP guidelines and requirements.
  • Experience in technical writing in support of regulatory submissions
  • Able to verbally communicate status updates, issues, and strategic solutions to problems.
  • Able to be flexible in a changing fast-paced entrepreneurial environment.

KNOWLEDGE, SKILLS, AND ABILITIES

  • Strong technical and interpersonal communication skills.
  • Excellent organizational skills.
  • Detail oriented and precision while able to see “big picture”.
  • Assertiveness, pro-activity, professionalism, and confidence.
  • Ability to multi-task and manage timelines.
  • Self-motivated and ability to problem solve
  • Willingness to travel and to participate in some teleconferences during non-business hours.

The salary range for this position is $190,000 to $199,000 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.

#LI-HYBRID

Mirum Pharmaceuticals is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and Local laws that prohibit employment discrimination on the basis of race, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability, veteran’s status or any other classification protected by applicable State/Federal/Local laws.

Mirum Pharmaceuticals provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in job application procedures.

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