What are the responsibilities and job description for the Sr Scientist, Formulation – Fill/Finish position at NWRPros?
Apply at NWRPros Here
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.
ROLE SUMMARY:
Our Client is 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 Formulation and Drug Product process development of clinical candidates.
The successful candidate will support the design, and execution of process characterization/validation studies, as well as lead technical process transfer to internal and external manufacturing sites, in support of clinical development and commercialization of our Client’s internal and partnered programs.
This individual will manage, supervise teams, and support program deliverables. 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.
Key Responsibilities include
Apply at NWRPros Here
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.
ROLE SUMMARY:
Our Client is 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 Formulation and Drug Product process development of clinical candidates.
The successful candidate will support the design, and execution of process characterization/validation studies, as well as lead technical process transfer to internal and external manufacturing sites, in support of clinical development and commercialization of our Client’s internal and partnered programs.
This individual will manage, supervise teams, and support program deliverables. 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.
Key Responsibilities include
- Lead the design and execution of formulation development and drug product process strategies to support regulatory filings (e.g., IND, BLA, MAA) and future commercial launch
- Conduct structured process characterization studies and interpret data using statistical tools to inform risk assessments and define control strategies
- Apply biophysical and analytical techniques (e.g., SEC-MALS, DLS, UV-Vis, spectroscopy) to characterize formulations and support stability programs
- Drive technology transfer activities to manufacturing partners (internal and external), including fill-finish operations and scale-up
- Support investigations and batch record review, and contribute to the continuous improvement of clinical and commercial drug product operations
- Author and review technical reports and study protocols for regulatory documentation and knowledge sharing
- Collaborate in cross-functional development teams, including CMC, clinical supply, quality, and regulatory affairs
- Mentor, manage, and grow technical staff to meet evolving business and scientific goals
- Ph.D. in a life science or engineering discipline (e.g., Pharmaceutical Sciences, Biochemistry, Chemical/Bioprocess Engineering) with 6 years of industry experience, or BS/MS with 8 years
- Prior work in formulation and drug product development of biologics, including hands-on experience with fill/finish operations
- Familiarity with gene therapy vectors (e.g., viral vectors, nucleic acid-based products) is desirable
- Strong understanding of analytical techniques and product characterization tools; experience with qPCR/ddPCR, particle sizing, or capillary-based methods is beneficial
- Knowledge of cGMP, Quality by Design (QbD) principles, and global regulatory standards for pharmaceutical product development
- Demonstrated ability to lead technical workstreams and contribute effectively in cross-functional team settings
- Experience managing or mentoring junior scientists or contractors is a plus
- Excellent written and verbal communication skills; ability to adapt scientific communication to technical and non-technical stakeholders
Apply at NWRPros Here
Salary : $160,200 - $213,500