CMC Product Manager
Overview
We are currently seeking a full-time, office-based CMC Product Manager to join LSK Biopharma. This position will manage and guide our CMC activities for our small molecule drug substance and product programs from preclinical through commercial.
If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you.
Responsibilities
- Direct contract manufacturing, packaging, labeling, and testing operations for clinical and commercial drug substance and drug products
- Manage contractors and third-party vendors to ensure products meet quality requirements and timelines
- Review and approve batch records for all CMC activities including manufacturing, release testing, stability programs, packaging, and labeling
- Develop stability programs to support shelf-life and cold chain management
- Develop production plans to support preclinical, clinical, and commercial programs
- Prepare and coordinate completion of domestic and global regulatory filing documents
Qualifications
- Minimum BA/BS in a scientific discipline (ideally chemistry, biochemistry, or a related pharmaceutical science)
- Minimum of five (5) years overall CMC experience in the pharmaceutical industry with preference for experience with instant release oral formulations
- Proven project management skills; ability to multi-task, meet deadlines as well as coach colleagues to meet deadlines
- Working knowledge of computer software, including advanced MS Word features.
- Experience with publishing tools and electronic document management systems as used within the pharmaceutical industry
- Strong problem-solving skills. Ability to manage tasks with clear objectives/goals, measures, process, progress, and results with attention to detail
- Strong interpersonal, communication and influencing skills and ability to collaborate effectively with other groups in a matrix organization
Benefits
- LSKB offers health and dental insurance, PTO days, 401k match, long term disability and life insurance.
Email a cover letter and resume to: angieprice@lskbiopharma.com
