Scientist, Analytical Sciences & Technology

ECLARO

East Syracuse, NY

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JOB DETAILS

SKILLS

Analysis Skills, Analytical Method Development, Assays, Biology, Biotech and Pharmaceutical, Calibration, Chemistry, Clinical Support, Communication Skills, Continuous Improvement, Delivery Management, Drug Products, Entrepreneurship, Establish Priorities, GMP (Good Manufacturing Practices), High Performance Liquid Chromatography (HPLC), Housekeeping/Cleaning, ICH Regulations, Identify Issues, Instrumentation, Interpersonal Skills, Laboratory Management, Manufacturing, Mass Spectrometry, Operational Audit, Order Supplies, Presentation/Verbal Skills, Problem Solving Skills, Procedure Development, Process Development, Process Improvement, Quality Assurance Methodology, Quality Control, Real-time PCR (qPCR), Regulations, Regulatory Submissions, Risk, Safety/Work Safety, Scientific Publications, Specimens/Samples, Standard Operating Procedures (SOP), Team Player, Technical Writing, Testing, Time Management, UV/VIS (Ultraviolet-Visible Spectroscopy), Writing Skills

LOCATION

East Syracuse, NY

POSTED

Today

Scientist, Analytical Sciences & Technology

This is a temporary position that will be filled for 8 months, however, may be extended based on employee performance and planned workload.

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

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.

About the Company

ECLARO

Eclaro is a Business and Technology Consulting Firm that connects top talent with opportunities nationwide. We have direct access to Hiring Managers from leading Fortune 1000 organizations in almost every industry segment, with particular expertise in:

• Technology and Business Consulting
• Financial Services and Insurance
• Pharmaceuticals and Life Sciences
• Consumer Products, Public Sector, and Utilities

Eclaro provides fully customizable, comprehensive talent acquisition and management of seasoned professionals through a number of business models, including:

• Consulting
• Professional Hiring
• Global Integrated Delivery™
• Managed Services

Eclaro recruits and manages a staff of highly skilled individuals in an array of specialized disciplines enabling our clients to leverage new opportunities, respond to increased and changing demands, and increase their profitability.

Eclaro’s Management Team averages over 25 years of experience in partnering with clients in technical, corporate operations and human capital solutions. We hold ISO 9001:2008 certification and have achieved SOC 2 Type 2 certification in Security, Availability and Confidentiality. Eclaro’s decades of expertise and collaborative practice have proven that The Right People are The Answer.

COMPANY SIZE

500 to 999 employees

INDUSTRY

Staffing/Employment Agencies

FOUNDED

1999

WEBSITE

http://www.eclaroit.com

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