Our client is a genomic medicine company building value with cutting-edge research across four distinct but complementary technology platforms – gene therapy, cell therapy, in vivo genome editing, and in vivo genome regulation. Our client is building a robust and differentiated genomic medicine pipeline that addresses patients with life-limiting conditions. They developed groundbreaking innovation to edit endogenous human genes, they were first to treat patients with gene edited T cells, and first to treat patients with in vivo genome editing. Our client has a primary value to create an inclusive environment that promotes and values diversity – it is a company where individuals can flourish, grow and develop their expertise. JOB SUMMARY: Reporting to the Vice President, this role will be responsible to:
Build, mentor, supervise a talented team of full-time employees, contractors and consultants to deliver organizational goals.
Devise Phase appropriate formulation & fill/finish strategy aligned with clinical/commercial landscape and organizational goals.
Create and oversee functional budgets, develop long range plans, set annual goals and map resources aligned with product and portfolio strategy.
Lead formulation and Drug Product deliverables to support pre-clinical, clinical/pivotal studies leading to IND, BLA/MAA and commercial launch.
Manage and coordinate resources across programs and teams to ensure timely and successful achievement of program/team goals.
Provide guidance to the formulation team in devising and directing process characterization/validation studies, and drive timely execution with quality oversight.
Drive DP technology transfer, process qualification and validation for accelerated BLA filing and commercial launch.
Provide on-going fill-finish manufacturing support to Drug Product sites/CMOs: including technology transfers, and impact assessments, during quality investigations to ensure product and process consistency.
Partner with internal/external manufacturing and quality for process improvement, transfers, compilation and review of batch records, master production records and technical support to resolve investigations, deviations, corrective/preventative actions.
Author and review technical protocols and reports, to document study findings in support of Investigational New Drug (IND), IND amendments, BLA/MAA and other global regulatory filings.
Lead and/or participate in CMC/project teams for functional representation as needed to support teams’ objectives and project deliverables.
Drive stakeholder alignment and influence cross-functional leadership on program and portfolio deliverables and milestones.
Demonstrate excellent communication, interpersonal skills and the ability to work effectively in a matrix organization to meet team objectives.
EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:
Ph.D., BS/MS in biochemistry, pharmaceutical sciences, biochemical engineering, or related discipline and 15+ years of product development experience and 5+ years of direct management experience.
Experience with biologics formulation development, Drug Product process design, and manufacturing Fill/Finish operation.
Experience with AAV gene therapy process/formulation/process development with CMO/external manufacturing is a plus.
Good knowledge of HA guidance as well as cGMP and ICH requirements.
Self-starter, solution oriented with collaborative mindset and strong executive presence with strategic and analytical abilities.
Target Pay Range: $265,000 - $312,000 per year The anticipated salary range is for candidates who will work in the San Francisco Bay Area work locations. The final salary offered to a successful candidate will be dependent on several factors that may include, but are not limited to, the type and length of experience with the job, type and length of experience within the industry, education, etc. The salary range may not apply to remote positions that work in other states.