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Senior Manager, Drug Product 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 

Will lead the technical drug product development and manufacturing function within a completely outsourced environment. The ideal candidate is a self-starter with the ability to work independently under minimal supervision, and who is seeking to be part of an innovative and fast-paced team. This role will provide scientific and technical oversight for activities occurring in the development and cGMP space.

JOB FUNCTIONS/RESPONSIBILITIES

  • Lead mid to late-stage drug product development and validation for multiple programs in a 100% out-sourced environment.
  • This position will be responsible for drug product development activities leading to NDA submission and commercialization and development and execution of the CMC strategy.
  • Design and oversee execution of QbD and risk-based studies, as well as process development activities in preparation for registration, validation, and commercialization activities.
  • This role also leads investigations into manufacturing related deviations, implementation of CAPAs, change management, and process monitoring, as well as lifecycle management of commercial and development products.
  • Author and review technical reports and CMC-related documents required for regulatory submissions.
  • Collaborate with cross-functional teams (manufacturing, analytical development, supply chain, quality, regulatory) to meet CMC goals.
  • Travel to CDMOs for vendor assessment and qualification and manufacturing oversight as needed.
  • Develops and delivers effective presentations with strong written and verbal communication.
  • Problem-solving and critical thinking skills.

QUALIFICATIONS

Education/Experience:

  • 5+ years in small molecule drug product development and manufacturing.
  • Expertise in development of novel formulations, technology transfer, process optimization and validation.
  • Track record of success in leading small-molecule drug product programs in a 100% outsourced small-team environment.
  • Thorough knowledge of the drug development process and sound understanding of CMC regulatory requirements.
  • Direct experience with compiling CMC sections for INDs, NDAs, and MAAs and responding to regulatory queries.
  • Experience with quality management systems for managing quality events and documents.

Knowledge, Skills and Abilities:

  • Strong ability to communicate effectively with team members, creating an environment that fosters successful teamwork, collaboration and cooperation.
  • Has integrity, honesty, conscientiousness, and is self-motivated.
  • Meticulousness with details while able to see “big picture”.
  • Strong collaborative vendor/supplier management skills.
  • Competency in developing, implementing, and delivering aggressive CMC project plans.
  • Ability to work in a fast-paced environment with demonstrated ability to juggle multiple competing tasks and demands, all while maintaining positive attitude.
  • Proactive, pragmatic, team player who can make decisions decisively in the face of ambiguity, demonstrates flexibility, possesses a “can do” attitude and can come up with creative solutions when faced with novel program challenges while showing good judgement and anticipating future consequences. Can prioritize and quickly re-prioritize as needed.
  • Experience in a small company environment strongly preferred.
  • Must be available for some teleconferences outside of standard California business hours.
  • Ability to travel up to 25% of time required.

 #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.