Sr. Sci/ Scientist III, Gene Therapy Formulation - Office or Remote


Ascent Life Sciences is hiring a Sr. Scientist.Seeking a highly motivated individual with drug product formulation and process development experience to contribute to the development of best-in-class viral vector and cell therapy products. The successful candidate will be responsible for the formulation and DP process development of clinical candidates, design and execute process characterization/validation studies, lead technical process transfer to internal and external manufacturing sites in support of clinical development and commercialization of Company's internal and partnered programs. The scientist will be responsible for authoring and reviewing technical reports and sections for regulatory submissions. They will operate in a matrixed environment and collaborate successfully with colleagues within Technical Operations and cross-functionally with clinical, external manufacturing, supply chain and commercial groups to drive product and process excellence. This individual will work independently, leading projects and self-managing work packages with appropriate communication and escalation.

Responsibilities:
  • 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
Qualifications:
  • 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 npotdar@ascentsg.com

Job Details

Job Type: Direct Placement
Location: Brisbane, CA
Job ID: 21-07350
Date Updated: September 17, 2021