Aptask Global Workforce (AGW) is seeking a Scientist, Analytical Sciences & Technology for a contract position with a Global Biotechnology Company located in East Syracuse, NY. This is a 12+ month contract opportunity. 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 raw materials, excipients, biologics and other modalities in-process, 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.
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
- 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 equivalent area of related study with 0-5 years industry experience in biologic/protein analytics
- 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
Desired skills: - Experience across the analytical method lifecycle in protein biotherapeutics for a variety of methodologies and instrumentation including HPLC/UPLC, 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
- Demonstrated history of continuous improvement
Pay range: up to $40.00 per hour
Only candidates available and ready to work directly as Aptask Global Workforce (AGW) employees will be considered for this position. If you have the described qualifications and are interested in this exciting opportunity, apply today! Aptask Global Workforce (AGW) ApTask Global Workforce (AGW) is a certified Minority and Veteran workforce solutions company. AGW delivers operational, clinical, lab and professional talent with a strong focus on healthcare and life sciences. The company supports clients with reliable staffing, program expertise and a commitment to quality, speed and consistent delivery.
Benefits of working with ApTask Global Workforce include: - Medical
- Dental
- Vision
- Sick Pay (for applicable states/municipalities)
Our team stays close to the process and is here to guide you every step of the way. To learn more, please visit our website
ApTask Global Workforce is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability or status as a protected veteran.
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