Associate Director / Director - Biologics CMC Lead

Location
San Francisco, CA
Posted
Sep 25, 2020
Ref
CMC
Required Education
Doctorate/PHD/MD
Position Type
Full time

Associate Director / Director - Biologics CMC Lead

Tallac Therapeutics Inc., is a privately held immuno-oncology company advancing innovative therapeutic approaches in disease areas of unmet medical needs. Our core technology platform enables us to discover and develop next generation protein therapeutics for targeted immune activation, harnessing the power of innate and adaptive immunity to fight cancer. We are looking for a highly-motivated Associate Director/Director, Biologics CMC Lead to join our team. The successful candidate will contribute to the development and manufacturing of Tallac drug substance and drug product. The candidate will also be involved in making key strategic and technical contributions to advance Tallac programs from pre-IND stage through late-stage clinical development, ensuring robust clinical supply.

Responsibilities:

  • Manage and supervise Contract Manufacturing Organization (CMO) partners to establish robust processes for drug substance and dug product manufacturing as well as reliable drug supply chain and distribution. This includes cell line development, upstream and downstream production, analytical and formulation development, drug stability studies, GMP production, drug product fill and distribution
  • Develop Chemistry, Manufacturing and Controls (CMC) plan in alignment with overall program strategy, ensure quality and timely supply of drug substance and drug product to support clinical studies
  • Review and approve protocols, technical reports, batch records, SOPs, manufacturing deviation investigations and cGMP-compliant documentation
  • Write, review and provide oversight for CMC drug substance and drug product sections of regulatory documents
  • Communicate effectively, build successful relationships and partnerships with internal teams, CMOs, vendors, and consultants
  • Track progress against deliverables, timelines, and cost; identify/solve technical, budgetary, and schedule risks to the program and propose appropriate risk response strategies
  • Maintains knowledge of current best manufacturing practices and regulatory guidance

Qualifications:

  • PhD or equivalent in Biochemistry, Protein Science, Chemical Engineering or related Life Science discipline, preferred. At least 8-10 yrs experience in biologics product development in the biotech or pharmaceutical industry. MS with extensive industry experience in manufacturing/CMC will be considered.
  • Extensive experience with the development, optimization and scale-up of manufacturing processes for biologic therapeutics. Experience with small molecule or DNA/RNA based drug manufacture is a plus. Formulation development expertise is a plus. Experience with therapeutic antibodies and antibody-conjugates desired.
  • Minimum of 5 years of management experience, including experience managing the work of other CMC internal, contract, and CMO staff.
  • Strong analytical and problem-solving skills, with ability to 'troubleshoot' in all areas of CMC.
  • Excellent interpersonal, organizational, negotiation and communication (verbal and written) skills are essential.
  • Leadership and management experience essential with proven ability to build a team, coach and motivate employees, set priorities, and effectively make decisions.

Tallac Therapeutics Inc., is an equal opportunity employer. All applicants should be legally entitled to work for any employer in the US. Title and salary are commensurate with experience. Our compensation program includes competitive salary and equity participation.

To apply for this position, please send your cover letter and resume.