Sr. Sci/ Scientist III, Gene Therapy Formulation - Office or Remote
- Plan, design and execute univariate/multivariate studies to develop robust and manufacturable formulations and processes for gene therapy products.
- Develop and implement Client biochemical and biophysical methods suitable for cell and gene therapy product characterization.
- Lead and/or participate in CMC/project teams for functional representation as well as support teams objectives and project deliverables.
- Author and review guidance documents, SOPs, technical protocols, reports and regulatory sections in support of Investigational New Drug (IND), IND amendments, BLA, as well as global marketing application submissions.
- 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.
- Manage and coordinate resources across programs and teams to ensure timely and successful achievement of program/team goals.
- Excellent communication and interpersonal skills, and proven ability to work effectively in a matrix organization to meet team objectives
- Ph.D. biochemistry, pharmaceutical sciences, biochemical engineering, or related discipline and of 5+ years of product development experience in industry or BS/MS with 10 + years of experience.
- Experience with biologics formulation development, DP process design and manufacturing Fill/Finish is highly desirable
- Proficiency with applying chromatographic (HPLC, UPLC, column chromatography) methods, capillary electrophoresis and biophysical techniques (UV-vis, DLS, CD, FTIR, DSC, AUC, Fluorescence, particle analysis, etc.) for formulation characterization.
- Experience in QbD methodologies and statistical analysis using JMP or Minitab.
- Good knowledge of HA guidance as well as cGMP and ICH requirements.
For immediate consideration please email resume to Neha at firstname.lastname@example.org
Job Type: Direct Placement
Location: Brisbane, CA
Job ID: 21-07350
Date Updated: September 17, 2021