Scientist/Senior Scientist, CMC/Drug Product

94080, South San Francisco
Jul 19, 2018
Required Education
Bachelors Degree
Position Type
Full time

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.

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.