CMC Senior Director
Overview
We are currently seeking a full-time, San Francisco office-based CMC Senior Director to join LSK BioPharma. This position will manage and guide our API and 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 to contribute to the approval and commercialization of a late stage cancer drug and where you can develop and grow your career even further, then this is the opportunity for you.
Responsibilities
- Direct contract manufacturing of API, and oversee drug product manufacture, packaging, labeling, and testing operations for clinical and commercial supply
- Manage contractors and third-party vendors to ensure products meet quality requirements and timelines
- Identify, select, and manage contract manufacturers for API, DP, packaging, labeling and distribution
- 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 shipping
- Develop API and DP production plans to support preclinical, clinical, and commercial programs
- Coordinate with Quality Assurance to ensure CMOs are implementing and validating phase appropriate analytical methods and protocols and that all CMOs are compliant with regulatory standards
- Prepare and coordinate completion of domestic and global regulatory filing documents
Qualifications and Experience
- PhD or MS with over 15 years’ experience. Advanced degree in chemistry, pharmaceutical chemistry, or related pharmaceutical science
- Experience with cGMP manufacturing, IND, and NDA filings, including knowledge of FDA and EMA regulations
- Experience in supply chain management
- 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.
About LSK BioPartners, Inc.
LSK BioPartners, Inc., d.b.a. LSK BioPharma, is a privately-held biopharmaceutical company with offices in Utah, California, Ireland, and South Korea. The Company specializes in clinical development of promising targeted therapies for unmet medical needs in cancer. LSKB’s lead proprietary drug candidates is rivoceranib, a selective VEGFR-2 inhibitor which has demonstrated clinical efficacy in a variety of solid tumors. LSKB can be found on the web at www.lskbiopharma.com.
