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Associate Protein Scientist
Ref No.: 18-00682
Location: Devens, Massachusetts
Position Type:Contract
Start Date / End Date: 05/28/2018 to 11/27/2018
ASSOCIATE PROTEIN SCIENTIST
DEVENS, MA


Project Description:
The Analytical Sciences & Technology group is committed to supporting our global biologics analytical network with reliability, integrity, active engagement, and cross functional collaboration. The Analytical CMC Strategy Group in the Analytical Sciences and Technology department provides analytical oversight for the transition of programs entering the commercial space following clinical development, and throughout commercial lifecycle.
  • Provide technical oversight and ownership of analytical methods.
  • Provide technical oversight of method revisions and improvements.
  • Provide expert input during periodic review of method performance and work with team leader to design and execute remediation experiments and implement changes to existing commercial methods.
  • Author and review sections of regulatory filings.
  • Respond to Health Authority queries regarding analytical methods.
  • Work collaboratively across organization and sites for method readiness, transfer, performance and trouble shooting in commercial environment.
  • Work closely with all AS&T team members to understand their deliverables to achieve organization goals.

Required Skills:
  • Bio-therapeutic development & industry experience required: BS with 4+ years, or MS with 2+ years.
  • Demonstrated experience with one or more protein separation methods, including Electrophoresis, Chromatography, and UVIS spectroscopy based technologies (for example SDS-PAGE, CE-SDS, icIEF, ion exchange, size exclusion, and RP HPLC, different modes of LC).
  • Familiarity with one or more protein characterization methods such as mass spectrometry, peptide mapping, and carbohydrate analysis.
  • Practical knowledge of Empower CDS.
  • Knowledge and understanding of regulatory guidelines including all major international guidelines (USP/ICH, EP, JP etc.).
  • Understanding of method validation and transfer.
  • Experience of working with colleagues at remote sites.
  • Understanding of GMP principles is expected.
  • Ability to work independently.
  • Strong written and communication skills and experience working in a matrix organization.
  • Good hands-on knowledge and experience with Empower chromatography CDS is required.
  • Knowledge of compendia methods would be a plus.
  • The successful candidate will participate in defining new scientific approaches and data analysis in a commercial environment.
  • Critical thinking, expertise in trouble-shooting of analytical methods and equipment as well as attention to detail is a must.
  • This may be a part laboratory based and part office based role. Candidate will be required to plan & execute experiments as well as analyze data generated at other sites for method troubleshooting and improvements.
  • Ability to work collaboratively and across different functions in fast-paced environment is required.

Physical Demands:
  • This role requires office work, biochemical laboratory work, computer work, group meetings, and thus involves the Sitting, standing, walking, working with analytical instruments, repetitive motion including bending and lifting small containers/equipment's.
  • Due to safety concerns in a laboratory setting this role requires sufficient manual dexterity and sufficient vision.

Work Environment:
  • Working in an analytical laboratory handling chemical reagents that may be hazardous (corrosive, toxic, flammable etc.).
  • Office work, teleconferencing, computer work, participation in meetings requiring working in open office environment, working alone and working with/around others.

Travel:
  • This position may require occasional domestic and international travel.


This 6+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Larry: larry@alphaconsulting.com


ALPHA'S REQUIREMENT #18-00682
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE