Associate Scientist, AS&T

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 manufacturing 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.

Requirements

• Education & Experience:
  • B.Sc./B.Eng. in Biology, Chemistry, Biotechnology, or equivalent area of related study with 3-5 years, or M.Sc./M.Eng. with 0-2 years, industry experience in biologic/protein analytics.
  • 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).
  • Working knowledge and experience in the biopharmaceutical development process, GMP, PAT, CMC and regulatory guidance, ICH guidelines, and compendial requirements.
  • Experience authoring, validating, and coordinating timely transfer of test methods with and to Quality Control laboratories.

Qualifications

• 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.

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.

Pay Range

$60,000 USD - $88,000 USD

Benefits

Not specified

Schedule

Not specified