Protein Scientist

POSITION SUMMARY

The Contractor Scientist within the Analytical Science and Technology team is responsible for supporting analytical method lifecycle activities including method development, qualification, validation, and technical transfer of methods for the testing of biologics drug substance and drug product samples. The candidate will execute non-GMP testing, non-GMP stability testing, reference standard qualification, and comparability studies to support clinical and/or commercial GMP manufacturing.

Duties/Responsibilities:

• Develop, author, and peer review standard operating procedures, analytical methods, protocols, reports, and other associated scientific technical documents.

• Perform testing of study samples to support upstream and downstream process development, characterization, and process improvements.

• Document and evaluate experimental results and perform data verification and trending.

• Provide technical expertise and guidance to support investigations and help troubleshoot analytical operational issues.

• Identify new analytical technologies and opportunities for technical advancements.

• Support the preparation and review of regulatory submissions related to analytical procedures, method development and validation, specifications, reference standards, extended characterization, and product stability/shelf-life.

• Support regulatory inspections, third-party audits, and customer audits through participating in inspection readiness and addressing inspectional findings.

• Perform routine laboratory activities including sample management, instrument maintenance and calibration, inventory and ordering of supplies, general housekeeping, and other related activities.

• Work in a diverse group environment while focusing on inclusivity and safety to produce high quality, compliant results.

Quals--

Education/Experience/Licenses/Certifications:

• B.S in Biology, Chemistry, Biotechnology, or equivalent area of related study, with 2–5 yrs. industry experience in biologic/protein analytics or M.S./Ph.D. with 0–5 yrs. experience.

• Experience across the analytical method lifecycle in protein biotherapeutics for a variety of methodologies and instrumentation used in the testing and characterization of raw materials, excipients, in-process, drug substance, and drug product samples including HPLC/UPLC methods and various other analytical techniques (i.e., qPCR, ELISA, CE-SDS, iCIEF, SDS-PAGE, UV-VIS, western blotting, mass spectrometry, and cell-based assays) is preferred.

• Working knowledge and experience in the biopharmaceutical development process, GMP, PAT, CMC and regulatory guidance, ICH guidelines, and compendial requirements is desired.

• Experience authoring, validating, and coordinating timely transfer of test methods with and to Quality Control laboratories is desired.

QUALIFICATIONS

Specific Knowledge, Skills, Abilities, etc:

• Strong written, verbal, presentation, and interpersonal communication skills.

• Detail oriented with good organization skills.

• Ability to prioritize, independently manage and complete deliverables within given timelines.

• Ability to problem solve and apply risk-based critical thinking in a technical environment.

• Demonstrated history of continuous improvement is desired

Physical Demands:

• The role is a combination of laboratory and office-based work.

• The laboratory work requires appropriate levels of personal protective equipment (PPE). The role may require contact with biohazardous materials such as live cell cultures and other hazardous chemicals including methotrexate, acids, and caustics. Powdered materials and high temperature liquids and solids may also be handled. Use of a respirator may be required.

• Frequent repeated motions such as pipetting, lifting, bending, twisting, squatting, crouching, sitting, kneeling, climbing on stepstools, and reaching may be required. Repetitive use of arms/hands/wrists and grasping may be required.

• The role may require unassisted lifting (not to exceed 50 lbs.).

Work Environment:

• Position is primarily laboratory and office based with occasional work in a classified GMP manufacturing environment.

• Dynamic, fast-paced, interactive, and entrepreneurial environment.

• Position is a team and project-based position that may require occasional shift work, weekends, and holidays.