Job Description
About the job Research Associate/Associate Scientist
About the Position We are hiring a Research Associate / Sr Research Associate / Associate Scientist in CMC to join our rapidly growing team. In this position, you will work on the development of analytical methods, protein characterization, and assist formulation development and stability programs for DS & DP. You will work with a team to support and expand analytical development, formulation development and stability to help advance novel cancer therapies into human clinical studies. This is a laboratory position and you should be hands-on and able to work independently. This position will report to an Analytical Scientist or Senior Director. The ideal candidate is also versed in GxP lab practices, including good documentation practices. The position will also be responsible for performing routine analytical testing in a quality regulated environment.
Summary of Key Responsibilities - Performs analytical sample analysis in support of process development using multiple techniques including ELISA, HPLC, CE, UV-Vis, etc.
- Familiar with Empower, Maurice, Waters/Thermo Fisher HPLCs, Softmax, Plate readers
- Aids in analytical testing for release & stability testing of drug substance, raw materials, intermediates, and drug product
- Help draft test methods for routine sample analysis
- Help identify analytical science capabilities and technology tools needed to enable research, manufacturing, process development, QC testing, and new drug candidate formulation development
- Helps maintain and organize the laboratory environment including samples, reagents, and instruments
- Assists analytical method transfer, qualification and validation to commercial QC and as needed for contract laboratories
- Assists development of scientifically sound and data driven specifications
- Helps prepare and delivers technical reports, documents, batch analyses, analytical methods, reference standard, etc. for regulatory submissions
- Knowledge of cGMP regulations
Required Qualifications - BS/MS in analytical chemistry, biochemistry, or protein chemistry with 1+ years biologic (prefer proteins) molecule analytical development experience in the biopharma/pharmaceutical industry
- Good scientific knowledge in analytical chemistry and protein chemistry
- Analytical development knowledge/experience for drug substance and drug product, a plus
Required Skills - Effective verbal and written communication skills
- Enjoys working in the laboratory
- Ability and track record of successfully working in cross-functional teams to progress projects as a representative of CMC team
- Ability to navigate and be successful in a fast-paced, matrixed work environment
- Desire to be a part of a highly innovative company aimed at helping patients with serious diseases
- A successful candidate must possess exceptional attention to detail, organizational, interpersonal, and communication skills, and demonstrate critical thinking and problem-solving ability.
- Must have the ability to multi-task to meet critical deadlines and the independent initiative to solve interdisciplinary problems.
- Candidate must be sharp, self-motivated, and able to thrive in a fast-paced dynamic biotech environment where flexibility, tolerability to rapid change, and drive to make a significant impact is essential.
- Must enjoy working in collaboration with others and small teams to achieve goals through effective building of relationships with co-workers.
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Job Tags
Contract work,