Gene Therapy Method Development Group Leader

Company: Eurofins USA PSS Insourcing Solutions
Location: Framingham
Posted on: May 26, 2023

Job Description:

We have an exciting, essential role for Raw Material Team Lead to support GMP lab operation and logistics around raw material testing at a client site in the Framingham, MA area. The responsibilities of this team and team leader will include sample receipt, quarantining raw material as per the appropriate material specification, documenting and inventorying samples for confirmatory identification and retention, packing out in a compliant manner retains for shipment to an offsite storage location, raw material testing, shipment, data review, trending and analysis.-- - We are looking for client service oriented employees to represent Eurofins, the world leader in testing for life. Position requires working onsite between Framingham and Waltham and reliable, personal transportation to do so.
The Ideal Candidate would possess: Performing cGMP raw materials management, testing, and inventoryUtilizing analytical chemistry approaches, e.g. Raman Spectroscopy, HPLC, FTIR, etc.Viral and Non-Viral Gene Therapy method development/method qualificationRoutine compendial testing including potentially rapid microbiological testingReceiving, quarantining, documenting, and inventorying samplesReviewing and curating data packs associated with material specifications for submission to SQO for final review and releaseTrending and analyzing the resultant data from the testing of the raw material using statistical analysis software systemsCritical laboratory reagent management, testing, and inventoryStandard buffer preparationMock sample analysis for Pharmacy testing for Trispecifics Minimum Qualifications: B.S. degree in science related field with 3-4 years of related experience or M.S. degree in science related field with 1-2 years of related experienceMust have experience with-- -Gene Therapy method development/method qualificationAt least one year of experience working in a GMP laboratoryLeadership experienceExperience-- -Preparing stability reports and managing-- -stability programs is preferredAccess to a reliable automobile and the ability to drive a vehicle with appropriate licensureGood communication skills both oral and writtenGood organizational skills
Position is full-time, Monday - Friday 8:00am - 5:00pm.-- -Candidates currently living within a commutable distance of Framingham,-- -MA-- -are encouraged to apply.-- -Excellent full time benefits including comprehensive medical coverage, dental, and vision options.-- - Position requires working onsite between Framingham and Waltham and reliable, personal transportation to do so. -- -Life and disability insurance401(k) with company matchPaid vacation and holidays Eurofins is a-- -M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer. PandoLogic. Keywords: Method Development Supervisor, Location: Framingham, MA - 01704

Keywords: Eurofins USA PSS Insourcing Solutions, Framingham , Gene Therapy Method Development Group Leader, Healthcare , Framingham, Massachusetts