West Chester, PA
SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire, and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to match professionals rapidly and precisely to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.
- Title: Research Associate
- Location: West Chester, PA
- Industry: Pharmaceutical
- Hours: - Mon - Fri 8am - 5pm
- Salary: $26 hour paid weekly with benefits options
- Employment Type: Long Term Contract
We are seeking a highly motivated individual with experience in anti-drug antibody (ADA) assay development, validation, and sample analysis in support of immunogenicity assessment of biologics. You will be a member of Specialty Bioanalytics, which plays a critical role in development of biological therapeutics from early stage research, IND enabling GLP studies, clinical trials through BLA submission and post marketing support.
Essential Job Functions:
Provide flow cytometry application support for in vitro cell proliferation assay
Participate in ADA method development, in support of preclinical and clinical immunogenicity assessment
Conduct method validation and sample analysis in a regulated environment, including but not limited to planning assay runs in Watson LIMS, performing the assay, and data summary
Perform data analysis using Watson LIMS, data transfer, and assist in preparation of assay validation report, and sample analysis report
Maintain laboratory records for compliance/regulatory audits
Procure, inventory, and track assay reagents
Help sample inventory in collaboration with sample management team and maintain sample chain of custody records
Required Knowledge and Skills:
B.S. in Immunology, Biology, Biochemistry, or a related field, with 1-4 years of regulated bioanalytical assay (PK, ADA, or biomarker) experience in pharmaceutical, biotechnology, and/or CRO industry.
Proficiency in Immunostaining, flow Cytometry acquisition and analysis. Hands-on experience with multicolor flow cytometry is preferred.
Must have working knowledge of GLP, GCP, SOPs and regulatory requirements.
Experience with ligand binding assays, cell-based assays, PK and/or ADA method development and validation, and execution of immunoassays for immunogenicity assessment is highly preferred.
Must be proficient in Excel as well as a lab data management system, with strong preference for Watson LIMS.
SoftMax Pro for data analysis and data summary as well as data transfer and report writing is a plus.
The candidate must be able to work collaboratively in a diverse, fast-paced environment with ability to multi-task. Good communication and interpersonal skills are required.
Teva s Equal Employment Opportunity Commitment
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.