Gene Therapy Method Development Group Leader

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.

Qualifications

The Ideal Candidate would possess:

• Performing cGMP raw materials management, testing, and inventory
• Utilizing analytical chemistry approaches, e.g. Raman Spectroscopy, HPLC, FTIR, etc.
• Viral and Non-Viral Gene Therapy method development/method qualification
• Routine compendial testing including potentially rapid microbiological testing
• Receiving, quarantining, documenting, and inventorying samples
• Reviewing and curating data packs associated with material specifications for submission to SQO for final review and release
• Trending and analyzing the resultant data from the testing of the raw material using statistical analysis software systems
• Critical laboratory reagent management, testing, and inventory
• Standard buffer preparation
• Mock 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 experience
• Must have experience with Gene Therapy method development/method qualification
• At least one year of experience working in a GMP laboratory
• Leadership experience
• Experience Preparing stability reports and managing stability programs is preferred
• Access to a reliable automobile and the ability to drive a vehicle with appropriate licensure
• Good communication skills both oral and written
• Good organizational skills

Additional Information

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 insurance
• 401(k) with company match
• Paid vacation and holidays

Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.