Scientist, Analytical Sciences & Technology

Scientist, Analytical Sciences & Technology East Syracuse, NY Job Details Temporary | Contract $34.46 - $40.00 an hour 18 hours ago Benefits Health insurance Dental insurance 401(k) Vision insurance Qualifications Biology Regulatory inspections Stability testing Western blot CGMP Molecular Biology Electrophoresis ELISA Laboratory inventory control Immunoassays Laboratory equipment maintenance Routine maintenance for instrumentation and control systems Technical documentation Immunological laboratory techniques Bachelor of Science High-performance liquid chromatography High-performance liquid chromatographs Hazmat Compliance audits & assessments Biotechnology GMP Mid-level Technical report writing Laboratory equipment calibration Bachelor's degree in biology ICH guidelines Bachelor's degree Continuous improvement Doctor of Philosophy Task prioritization Scientific protocols Master of Science Pharmaceutical analysis Ultraviolet-visible (UV-Vis) spectroscopy Quality control Organizational skills Cleaning Mass spectrometers (MS) Chemistry, manufacturing & controls Chemistry Regulatory submissions Manufacturing Instrument maintenance Bachelor's degree in biotechnology Communication skills Bachelor's degree in chemistry Under 1 year PCR Full Job Description AllSTEM Connections is seeking a Scientist, Analytical Sciences & Technology to work onsite in East Syracuse, NY. This is a 6-month contract position. Possible extension/temp-to-hire. Hourly rate is up to $40/hour .

M-F, 8AM - 5PM. 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 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. 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.

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.

QUALIFICATIONS

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. 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

Job Types:

Contract, Temporary Pay:

$34.46 - $40.00 per hour

Benefits:

401(k) Dental insurance Health insurance Vision insurance

Education:

Bachelor's (Required)

Experience:

CGMP:

1 year (Required) Ability to

Commute:

East Syracuse, NY 13057 (Required)

Work Location:

In person