Let your remarkable
shine through
Director, API/Drug Substance Manufacturing
Foster City
MISSION
Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases affecting children and adults. Propelled by our passion for patients and their families, we’re focused on turning possibilities into realities. Using data and meaningful evidence, our goal is to transform scientific discoveries into therapies that are poised to positively impact the treatment of rare diseases. 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. Learn more about our work, our culture, and what it’s like to be a part of our team: www.mirumpharma.com.
POSITION SUMMARY
We are looking for a Director 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 tactically 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 pharmaceutical company. This position is in Foster City, CA.
JOB FUNCTIONS/RESPONSIBILITIES
- Achieve established timelines and within budget.
- Support drug substance development and manufacturing function within a small dynamic team for multiple late-stage programs.
- Support the tech transfer and production for late-stage and commercial supply.
- Work with supply chain for drug substance supporting clinical trials through commercialization.
- Oversee pre-NDA activities such as, process optimization, manufacturing, and validation.
- Review production documentation and reports.
- Author and review regulatory submission documents to help support an NDA/MAA.
QUALIFICATIONS
Education/Experience:
- Bachelor’s degree or higher. PhD in organic chemistry is preferred.
- At least 12+ years of work experience in the pharmaceutical/biotech industry with at least 6 years in API/drug substance manufacturing with small molecules.
- Experience with building successful, collaborative relationships with CMOs.
- Strong knowledge of US and European cGMP guidelines and requirements.
- Strong written skills on previous NDAs and MAAs required.
- Able to verbally communicate status updates, issues, and strategic solutions to problems.
- Must be able to function in a fast-paced entrepreneurial environment.
- Able to be flexible in a changing environment.
Knowledge, Skills, and Abilities:
- Strong interpersonal and problem-solving skills.
- Late-stage development and validation experience.
- Meticulousness with details and precision while able to see “big picture”.
- Assertiveness, pro-activity, professionalism, and confidence.
- Ability to multi-task and handle pressure.
- Drive for excellence and self-motivated.
- Willingness to travel and to participate in some teleconferences during non-business hours.
#LI-Onsite
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.
