What are the responsibilities and job description for the Temporary Scientist, Formulation Fill+Finish position at NWRPros?
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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 have 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:
Our Client is seeking a highly motivated individual with drug product formulation and/or 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, develop and implement novel biochemical and biophysical methods for product characterization. The successful candidate will also support process characterization/validation studies, and support technical process transfer to internal and external manufacturing sites. Managing these partnerships supports the clinical development and commercialization of both internal and partnered programs. This position will operate in a matrixed environment and collaborate with colleagues within Technical Operations and cross-functionally with clinical, external manufacturing, supply chain and commercial groups to drive product and process excellence. This is a temporary position, working onsite in our client’s San Francisco Bay Area facility.
Position Duties include:
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 have 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:
Our Client is seeking a highly motivated individual with drug product formulation and/or 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, develop and implement novel biochemical and biophysical methods for product characterization. The successful candidate will also support process characterization/validation studies, and support technical process transfer to internal and external manufacturing sites. Managing these partnerships supports the clinical development and commercialization of both internal and partnered programs. This position will operate in a matrixed environment and collaborate with colleagues within Technical Operations and cross-functionally with clinical, external manufacturing, supply chain and commercial groups to drive product and process excellence. This is a temporary position, working onsite in our client’s San Francisco Bay Area facility.
Position Duties include:
- Plan, design and execute univariate/multivariate studies to develop robust and manufacturable formulations and DP processes
- Process data, compile results, report and communicate study findings in the form of presentations, reports and external publications
- Develop and implement novel 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 technical protocols and reports to document study findings 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.
- Excellent communication and interpersonal skills, with proven ability to work effectively in cross-functional teams to meet project milestones and timelines.
- Scientific curiosity and creative problem-solving skills are highly desirable
- BS/MS/PhD degree in biochemistry, pharmaceutical sciences, biochemical engineering, or related discipline.
- 0 - 2 years (PhD) or 5 years (MS/BS) of laboratory experience in biotechnology or pharmaceutical industry.
- Experience with formulation development, DP process design and manufacturing Fill/Finish is highly desirable, however, academic experience related to cell culture, analytical chemistry, viral vectors, or gene therapy will be considered.
- 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
- AAV gene therapy, Cell Therapy & Gene Editing experience is desirable.
- Sound understanding of statistical methods and data analysis tools (e.g. JMP)