Sangamo Therapeutics, Inc. · 2 months ago
Senior Scientist, Formulation Fill/Finish
Brisbane, CA
Full-time
Onsite
Senior Level
$167K/yr - $178K/yr
6+ years expSangamo Therapeutics is a genomic medicine company focused on treating debilitating neurological diseases. The role involves leading formulation and drug product process development for clinical candidates, collaborating with various teams to ensure product and process excellence, and managing teams to support program deliverables.
BiotechnologyGeneticsHealth CarePharmaceuticalTherapeutics
Hiring Manager
Angela Barbary
Responsibilities
Lead formulation and Drug Product deliverables to support pre-clinical, clinical/pivotal studies leading to IND, BLA/MAA and commercial launch
Plan, design and execute univariate/multivariate formulation and DP process characterization/validation studies, and drive timely execution with quality oversight
Perform analytical testing with chromatographic and biophysical methods (e.g. SEC-MALS, DLS, spectroscopy etc.) to support product and process characterization
Devise the DP process technology transfer, qualification, and validation strategy, for clinical/commercial product site transfer
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 well as support teams’ objectives and project deliverables
Develop and implement novel biochemical and biophysical methods suitable for gene therapy molecular assessment and product characterization
Build, mentor, and supervise full-time employees, contractors, and consultants, to deliver organizational goals
Qualification
Required
Ph.D. in biochemistry, pharmaceutical sciences, biochemical engineering, or related discipline and 6+ years of product development experience in industry or BS/MS with 8+ years of experience
Experience with biologics formulation development, Drug Product process design, and manufacturing Fill/Finish
Sound understanding of analytical methods for formulation characterization (e.g. qPCR/ddPCR, UV-vis, H/UPLC, capillary electrophoresis and biophysical techniques (e.g. SEC-MALS, DLS, AUC, Fluorescence, particle analysis, etc.)
Experience in QbD methodologies and statistical analysis using JMP or Minitab
Good knowledge of HA guidance as well as cGMP and ICH requirements
Experience writing, proofing, contributing to regulatory submissions, through all phases of product development
Self-starter, solution oriented with collaborative mindset and strong executive presence with strategic and analytical abilities
Excellent communication, interpersonal skills, and proven ability to work effectively in a matrix organization to meet team objectives
Preferred
Experience with AAV gene therapy process/formulation/analytical development
Experience with BLA submissions
Company
Sangamo Therapeutics, Inc.
For Sangamo Therapeutics, science is a means to develop new medicines with the potential to transform the lives of patients living with serious genetic diseases.
201-500 employees
H1B Sponsorship
Sangamo Therapeutics, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (3)
2023 (7)
2022 (14)
2021 (14)
2020 (8)
Funding
Current Stage
Public CompanyTotal Funding
$569.1MKey Investors
California Institute for Regenerative MedicineNational Institutes of Health
2025-05-12Post Ipo Equity· $23M
2024-03-22Post Ipo Equity· $24M
2019-04-03Post Ipo Equity· $145.5M
Leadership Team
Sandy Macrae
Chief Executive Officer
Prathyusha Duraibabu
Chief Financial Officer
Recent News
2025-12-02
Sangamo Therapeutics, Inc.
2025-12-02
Company data provided by crunchbase