Kelly Services Senior Scientist - Perm Opportunity in Cambridge, Massachusetts

Kelly Services is currently recruiting for a Senior / Lead Scientist with R&D pharmaceutical experience interested in a Direct Hire position in Cambridge, MA for one of our top clients.

The Sr. Scientist will work in the Analytical Test Management and Controls Biologics Group and will be empowered to work independently to interpret and communicate QC results and own the technical aspects of various projects.

A typical day will include:

  • Providing technical leadership and management of project implementation and coordination by independently planning and executing unit operations.

  • Prepare documentation and provide support/trouble shooting during Quality Control testing release and stability, Out Of Specifications /Atypical Investigations at vendor sites.

Primary Responsibilities of the Senior / Lead Scientist (Lead Quality Control Analyst / Manager) includes:

  • Ensuring QC requirements are met over life cycle of assigned clinical project including GMP release, stability, retest period extensions, reference standard re-qualifications, specification updates, method transfers, and method validations/verifications

  • Preparing protocols, reports to support GMP product development.

  • Participate in projects which include multiple projects within functional area.

  • Reviewing, interpreting and communicating data internally (e.g., to supervisor, project teams) and prepares technical reports.

  • Proposing and implementing resolutions to technical GMP problems/issues

  • Participates as team member on CMC project teams and communicates activities from designated functional area to project team

  • Assists with the development of project strategy and communicates complex data/decisions within department and cross functionally as necessary

  • Supporting initiatives as directed by supervisor and participates in global CMC or functional initiatives as appropriate.

  • Serves as a technical resource for junior staff and leverages expertise in GMPs as a functional resource/trainer.

  • Assisting more senior managers in project management activities such as data review and electronic data management.

Education and Experience Requirements of the Senior / Lead Scientist (Lead Quality Control Analyst / Manager) includes:

  • Associates degree in Chemistry, Biology or equivalent with +7 years relevant industry experience, Bachelor’s degree in Chemistry, Biology or equivalent with 5+ year’s relevant industry experience, or Master’s degree in Chemistry, Biology or equivalent with 3+ years relevant industry.

  • Scientist must have Biologics GMP drug development experience and a solid understanding of Quality Control CMC requirements for Biologics IND, BLA, and other global regulatory filings.

  • Proficiency with electronic documentation (e.g., LIMS and excursions management system) and stability data trending using statistical tools.

  • Laboratory skills required include: Cation-Exchange Chromatography (CEX), Capillary Isoelectric Focusing (iCEF), SDS-PAGE, Capillary electrophoresis- SDS (CE-SDS), Size Exclusion Chromatography (SEC), Binding Efficacy, cell-based bioassays, ELISA, Residual CHO DNA by qPCR, RP-HPLC, Gas Chromatography, Karl Fischer titration, UV Spectrophotometry, FTIR, Protein concentration by UV spectrometry, sub-visible particles testing by light obscuration/microscopy, Endotoxin LAL, Sterility, and Bioburden.

Additional Information:

  • Direct Hire position.

  • Work schedule: full-time.

  • Pay rate is based on education and experience, however range is $80,000 - $120,000/year.

  • Additional perks may include: 401(k) with company match and annual retirement contribution plan, tuition reimbursement, company match of charitable contributions, health & wellness programs including onsite flu shots and health screenings, generous time off for vacation and the option to purchase additional vacation days and community outreach programs.

Apply Now!

This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must submit your resumes. Due to the high volume of responses anticipated, only qualified candidates will be contacted. Thank you for your interest in the assignment.

Why Kelly ® ?

With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 11,000 scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.

AboutKelly Services ®

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2016 was $5.3 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm