Senior Analyst I, Quality Control Chemistry Job at Tandym Group, Woburn, MA

S1puRHhCOEJBWTV3alN0bC80L05pZ2dvUGc9PQ==
  • Tandym Group
  • Woburn, MA

Job Description

A recognized pharma company is hiring a Senior Analyst I, Quality Control Chemistry on a one-year contract basis near Boston, MA. In this role, the Senior Analyst will specifically support the gene therapy program pipeline, including technical transfer, method qualification, validation, verification, assay trending and routine GMP testing of AAV vector analytical methods (HPLC, LCMS, AUC, UV, CE-SDS, compendia methods and other methods as needed) for lot release and stability.

Responsibilities:

  • Execute analytical test methods to support product release and stability of AAV products using different analytical techniques (e.g. HPLC, LCMS, AUC, UV, CE-SDS, compendia methods like Osmolality, pH, Sub visible particulates and Appearance)
  • Review and approval of cGMP analytical data for release and stability testing from chemistry analytical test methods
  • Supports and leads QC Chemistry laboratory operations (ex. Instrument qualification and maintenance. Housekeeping, qualify critical reagents, etc).
  • Author and support quality events; Change controls, Deviation, CAPA, OOS Investigation, as needed
  • Write, prepare, and present technical data, technical reports, and standard operating procedures (SOPs), Method transfer/ validation protocol, Method transfer/ validation report for internal and external methods
  • Perform other duties, as needed

Qualifications:

  • 5+ years of experience working in c GMP environment
  • Bachelor's and/or Master's Degree Analytical Chemistry, Biochemistry, Biophysics, or a related discipline
  • Experience working in the cGMP QC lab of the pharmaceutical or biopharmaceutical industry

Desired Skills:

  • Experience analyzing nucleic acids, virus capsids, antibodies, and/or other biologics materials using HPLC/UPLC, LCMS, AUC, UV- Vis, CE-SDS
  • Experience working with external contract labs (CMOs, CROs)

Job Tags

Contract work,

Similar Jobs

MLR.org

Acute Surgical Tech Job at MLR.org

Looking for a Surgical Tech to Join Our Close-Knit Team in Kearney, NENestled in the heart of Nebraska, Kearney offers a unique blend of small-town charm and modern amenities. With its rich history, vibrant community, and access to outdoor activities, it's an ideal place... 

State Farm

Baker City OR - Operate A State Farm Agency Job at State Farm

 ...Join Our Entrepreneurs In Baker City, OR With the brand recognition of a Fortune 500 company, State Farm agents offer products to help customers meet their insurance and financial service needs. Being a State Farm agent gives you a unique opportunity run your... 

University of Miami

Nurse Educator 1 Job at University of Miami

 ...Miami Health System, "UHealth", Department of Pediatrics- Endocrinology has an exciting opportunity for a Full-Time Classroom Nurse Educator 1 to work in Miami. The Nurse Educator 1 is a Registered Nurse responsible for unit(s)-specific professional development... 

GeorgiaTEK Systems Inc.

Data Entry Specialist Job at GeorgiaTEK Systems Inc.

 ...applications such as Microsoft Word and Excel. Please be specific on what Knowledge is needed for Work and Excel Education/Experience: High school diploma or GED required. Minimum 2 years of office / business experience. Personal Lines Insurance knowledge and plus.... 

BNP Associates, Inc.

Senior Designer - Apron Systems Job at BNP Associates, Inc.

 ...checked baggage security screening, aircraft apron systems, air cargo terminals, and construction administration. Our clients include airlines, airports, government agencies, and transportation infrastructure specialists worldwide. BNP serves as a key design partner for...