Sr. Scientist, CMC/Drug Product
The CMC department at Calithera Biosciences is seeking a highly motivated individual to oversee Drug Product development and manufacturing of small molecule oncologic agents. Candidates should have strong background in oral solid dose formulation development, Drug Product manufacturing, and have a track record managing contract research organizations (CROs) and contract manufacturing and distribution organizations (CDMOs) successfully providing GMP drug product manufacturing and stability testing that met corporate quality and timeline objectives.
Calithera is focused on discovering and developing small molecule drugs that slow tumor growth through controlling key metabolic pathways in the tumor and immune cells.
Tumor metabolism and tumor immunology are promising new interrelated fields for cancer drug discovery. Recent clinical successes have demonstrated the potential to slow abnormal cell growth and create fundamentally new therapies for cancer patients. Our investigational onco-metabolism medicines take advantage of the specific metabolic requirements of tumor cells and cancer-fighting immune cells.
Calithera’s discovery and development efforts are focused on diseases for which new treatments are urgently needed for patients suffering from renal cell carcinoma, triple negative breast cancer and other tumor types.
Duties and Responsibilities:
- Provide scientific leadership for pre-formulation, formulation development and drug product manufacturing process development activities for solid dose oral drug products
- Manage CROs conducting formulation development and GMP manufacturing of Drug Product and function as Person-in-Plant as needed
- Guide external operations through tech transfer, process and method development, optimization, qualification, and validation of the activities related to drug product manufacturing operations
- Conduct technical batch record review of all drug product manufacturing programs and support review of drug substance analytical methods
- Prepare technical documents for internal and external use, for CMC section of regulatory filings (INDs, IMPDs, etc.) and for CRO/CDMO tech transfer activities
- As needed, conduct in-house pre-formulation, formulation, analytical development, stability and other studies for early stage drug discovery programs
- Assist as needed in clinical supply chain activities
Qualifications and Requirements:
- BS, MS or PhD in pharmaceutical, chemical or biological sciences with a 3 – 8 years relevant industrial research and development experience
- Strong background solid dose manufacturing techniques (granulation, extrusion, etc.), analytical support, and other techniques used in the physical and chemical characterization of drug substance and drug product
- Experience managing GMP Drug Product manufacturing at CROs/CDMOs
- Knowledge and understanding of GMPs
- Independent problem-solving and troubleshooting abilities
- Excellent oral and written communication skills
- Ability to work independently as well as in a highly interactive team environment
- A flexible, “whatever it takes” attitude
- Local candidates only
Calithera Biosciences, Inc. is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.