Analytical Sciences & Technology Scientist

About the role

This is a combination of laboratory and office-based work within the Analytical Science and Technology team. The role requires handling biohazardous materials, hazardous chemicals, powdered materials, and high-temperature liquids/solids. Appropriate personal protective equipment (PPE), including potential respirator use, is required. Frequent repeated motions (e.g., pipetting, lifting, bending, twisting) and unassisted lifting (up to 50 lbs.) may be necessary. The position is primarily laboratory and office-based with occasional work in a classified GMP manufacturing environment.

Responsibilities

• Support analytical method lifecycle activities, including method development, qualification, validation, and technical transfer for testing raw materials, excipients, biologics, and other modalities in-process, drug substance, and drug product samples.
• Execute non-GMP testing, non-GMP stability testing, reference standard qualification, and comparability studies to support clinical and/or commercial GMP manufacturing.
• Develop, author, and peer review standard operating procedures, analytical methods, protocols, reports, and other 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, perform data verification, and trending.
• Provide technical expertise and guidance to support investigations and 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 inspection readiness and addressing findings.
• Perform routine laboratory activities, including sample management, instrument maintenance and calibration, inventory and ordering of supplies, and general housekeeping.
• Work in a diverse group environment while focusing on inclusivity and safety to produce high-quality, compliant results.

Requirements

• B.Sc./B.Eng. or M.Sc./M.Eng. in Biology, Chemistry, Biotechnology, or an equivalent area of study with 0-5 years of industry experience in biologic/protein analytics.
• Experience across the analytical method lifecycle in protein biotherapeutics for methodologies and instrumentation used in testing and characterization (e.g., HPLC/UPLC, qPCR, ELISA, CE-SDS, iCIEF, SDS-PAGE, UV-VIS, western blotting, mass spectrometry, and cell-based assays).
• Experience in the biopharmaceutical development process, GMP, PAT, CMC, 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.
• Must have 2-3 years in a science background and the ability to articulate and communicate clearly.
• Protein therapeutic exposure is preferred.
• Dynamic, fast-paced, interactive, and entrepreneurial environment; may require occasional shift work, weekends, and holidays.

Skills

• Strong written, verbal, presentation, and interpersonal communication skills.
• Detail-oriented with good organizational skills.
• Ability to prioritize, independently manage, and complete deliverables within given timelines.
• Problem-solving skills and ability to apply risk-based critical thinking in a technical environment.
• Demonstrated history of continuous improvement.
• Must arrive at work at least 30 minutes before the 9 AM work huddle and work 8 hours a day, Monday through Friday.

Benefits

• Healthcare Insurance: Coverage through BlueCross BlueShield of Illinois for eligible employees and dependents, beginning on the 1st day of the calendar month following 60 days of continuous full-time employment. Premiums are subsidized by Synectics.
• Dental Insurance: Plan through MetLife for eligible employees and dependents, beginning on the 1st day of the calendar month following 60 days of continuous full-time employment.
• Vision Insurance: Coverage through VSP for eligible employees, beginning on the 1st day of the calendar month following 60 days of continuous full-time employment.
• 401(k) Plan: Opportunity to invest in the Synectics Inc. Investment Savings Retirement Plan on the first of the month following at least 1 calendar year of employment. Open to employees aged 21 or older.