Research Associate II
Job Title: Research Associate II
Supervisor: Product Development Manager
The Product Development Group is seeking a highly motivated scientist with a B.S. or M.S. in cell biology, immunology, biomaterials, or a related field, and 1-2 years of relevant experience to contribute to our drug discovery/drug delivery programs. The individual should possess strong competency in primary and immortalized cell culture techniques as well as in the development of cell and microbial-based assays to determine API activity and biomaterial interaction. The individual should also demonstrate knowledge of experimental design, be able to competently and rigorously analyze and assess results, and generate Test Protocols and Reports. Industry experience and experience in drug delivery are strongly preferred.
Strategic Focus Areas:
- Perform a variety of molecular and cellular assays to advance drug discovery, target identification/validation, and drug delivery programs.
- Assist in the incorporation of proprietary technology to drug delivery systems and assess its effect on API activity and stability.
- Effectively collaborate with colleagues to meet corporate objectives and drive business results.
- Hold to Product Development timelines and budgets, and maintain cost discipline within assigned programs.
Specific Tactical Responsibilities:
- Maintain all cell line and cell culture-related inventory: Extensive experience in isolation, culture, and maintenance of primary cells, as well as maintenance of immortalized cell lines, is required.
- With guidance, design and develop molecular and cellular biology-based assays (e.g., ELISA, FACS, qPCR, Western Blotting, immunohistochemistry/immunocytochemistry, etc.) to screen activity and stability of established products and new product candidates.
- Collaborate internally as required to facilitate assay validation and transfer.
- Collaborate with external stakeholders to co-ordinate appropriate pre-clinical testing.
- Participate in diverse project teams throughout all stages of product development.
- Maintain up to date records of laboratory activities and test results.
- Maintain a familiarity with good laboratory practices and established and emerging techniques and technologies.
- Review literature, FDA guidance documents, ISO and ASTM standards, etc. to maintain design control documentation.
- Author, review, and revise testing protocols and reports and other technical documents.
- Participate in root cause analyses of technical issues in collaboration with other members of the Product Development group.
- Responsible for other duties and projects as assigned.
Assignments are defined by objective and required outcome. Exercises judgment within defined parameters and policies; expected to propose practice and policy improvements. Job requires maintenance of up to date knowledge of all applicable molecular and cellular biology techniques, and regulatory and industry standards.
- B.S. or M.S. in biochemistry, immunology, biomaterials, or a related field