We are seeking a highly motivated and scientifically rigorous individual to join our CMC team as Director, Analytical Development CMC. The position will focus on drug substance and drug product manufacture, drug formulation, regulatory and analytical support, including development, validation, and data review for drug substances and drug products. This role will also provide technical support for the pharmaceutical development of Translate Bio’s Messenger RNA Therapeutics lead candidates. This individual will oversee development of scalable and robust formulation processes for drug substance and drug product and serve as the process knowledge link between Process Development and Drug Substance and Drug Product Manufacturing.
- Provide technical leadership for drug product development and tech transfer activities.
- Author/review development documents and support IND regulatory submissions
- Represent within cross functional project teams including process development, CMC and tech transfer teams
- Manages and oversees the development of drug substances and drug formulations and/or transfer of development activities with Translate Bio contractors.
- Provides technical input for selecting external contractors as well as managing the day-to-day contractor activities with MRT Program Managers.
- Leads drug /device compatibility assessment activities.
- Works closely with GMP manufacturers of drug products and drug substances.
- Writes/reviews protocols and performs batch record review for manufacturer of drug substances and drug products.
- Writes/reviews analytical method protocols and stability protocols.
- Writes CMC and drug/device compatibility documents to support IND filings.
- Assists in the review and evaluation of CMC documents during a due diligence exercise.
Uses DOE and QbD principles in developing robust API and Finished Product manufacturing processes
Provides any necessary support to line manager as required
Key Skills and Competencies
- Ability to direct /lead tech transfer teams and work with CMO on cGMP manufacture and release of drug product.
- Extensive experience and demonstrated track record in biopharmaceutical development including but not limited to formulation development, drug product development, drug product process characterization and validation.
- In-depth understanding of nucleic acid drug development, formulation, delivery systems and drug/device characterization.
- Must be well-organized and self-motivated and possess an independent work style.
- Ability to lead effectively and concurrently on multiple projects in a goal-oriented, timeline-driven, and dynamic work environment while ensuring quality and accuracy.
- Proactively identify potential issues and develop creative solutions to technical problems to keep projects on schedule.
- Excellent interpersonal skills with the ability to interact professionally and effectively with peers, management, and leadership both within and outside Translate Bio.
- Ph.D. degree in pharmaceutical chemistry, biochemistry, engineering or related disciplines
- Minimum of 8 years of experience in pharmaceutical development and manufacturing of nucleic acid-based therapeutics
- Experience with PD/manufacturing, release testing, formulation development, drug/device characterization
Translate Bio is committed to equal employment opportunity. All applicants must have authorization to work in the U.S.