Kelly Services Lead Scientist, Quality Control in Cambridge, Massachusetts

Lead Scientist, Quality Control—Cambridge, MA

Direct Hire

Job Description :

As a Lead Scientist / Quality Control Manager working on the Analytical Test Management and Controls Biologics, you will be empowered to work independently to interpret and communicate QC results and owns the technical aspects of a project. 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.

The accountabilities for this position include, but not limited, to the following:

  • 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.

REQUIRED QUALIFICATIONS:

  • 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

  • Masters degree in Chemistry, Biology or equivalent with 3+ years relevant industry experience

  • Minimum of 3 years experience in Quality Control and/or Analytical Development.

Technical skills:

  • 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.

PREFERRED QUALIFICATIONS:

  • Biologics GMP drug development experience

  • Biologics IND, BLA, and other global regulatory filings experience.

  • Proficiency with electronic documentation (e.g., LIMS and excursions management system).

  • Proficiency in stability data trending using statistical tools

WHAT WE CAN OFFER YOU:

  • 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

  • Community Outreach Programs

Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, please apply. If you have questions, you may contact the recruiter at adora.parker@kellyscientific.com

We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide: www.kellyservices.com at http://www.kellyservices.com/ .

Kelly Services® is a U.S.-based Fortune 500 company. With our global network of branch locations, we are uniquely positioned to provide our customers with international staffing support and our employees with diverse assignments around the world.

Kelly Services is an Equal Opportunity Employer

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