When you’re part of the team at Thermo Fisher Scientific, you’ll do important work. Surrounded by collaborative colleagues, you’ll have the support and opportunities that only a global leader can give you. Our respected, growing organization has an outstanding strategy for the near term and beyond. Take your place on our strong team, and help us make meaningful contributions to the world.

Location/Division Specific Information

The Purification and Pharma Analytics (PPA) business develops and produces products for the purification of biotherapeutics including antibody therapies and vaccines such as those for the treatment of COVID-19. This position supports the quality control HPLC team for our BioProduction group at Bedford, MA.

How will you make an impact?

HPLC, QC Supervisor primary responsible to assure the quality products delivered to our customers from Bedford BPG MFG location. Duties include setting up work schedule, staff engagement, helping to resolve laboratory issues associated with HPLC test method and instruments, investigating OOS and motivating technical staff for constant improvement and involvement.

What will you do?

As a HPLC Group Leader, you will work onsite supporting the Manufacturing and MSE (Manufacturing Sciences and Engineering) Group. Serve as working leader to support daily QC activities of the HPLC group to ensure appropriate quality output and maintenance of product release schedules, assist in troubleshooting, support lab investigations, perform data verification and Batch records Review.

Being responsible for developing and empowering staff; building effective team that apply their diverse skills and perspectives to achieve common goals; work with cross functional team to support QC operation, Onboard, train, and mentor new staff. More specific details on job responsibilities are as follows:

• Support POROS product lines and new product development activities for downstream processing
• Serve as technical support for purification resins HPLC testing, troubleshoot testing issues and lead investigations for out-of-specification results.
• Communicate results to collaborators and management leaders in daily Tier meetings.
• Provide support with internal/external Audits, Risk assessment, SOP improvement and drive site Safety initiatives.

How will you get here?

Education

• A Bachelor's in a life sciences field (e.g. Biology, Chemistry, Biochemistry) is required. Master's Degree in Chemistry or Biochemistry will be preferred. Experience in Biopharma industry may be considered in lieu of a degree.

Experience

• Minimum of 3+ years in a downstream setting where chromatography-based purification methods were used.
• Experience with a range of organic analytical chemistry techniques with particular emphasis on chromatographic methods (HPLC, GC, Ion Chromatography, LC-MS).
• Experience with process scale column packing.
• Knowledge of ISO:13485 regulations, GMPs, and Quality Systems relevant to the manufacture of pharmaceuticals.
• At least 1 year supervisory/ team lead experience within the pharmaceutical industry at management level.
• Familiarity with software for inventory and document control i.e., Agile, Trackwise, SAP, Kneat is a plus.

Knowledge, Skills, Abilities

• Ability to operate and interpret data from AKTA or alternative process development LC chromatography workstations
• Knowledge of small scale, pilot scale and large scale chromatography and column packing.
• Demonstrate experience to lead technical team, analyze data, troubleshoot, technical writing, SOP reviews and speak in a public setting
• Good problem solving skills and logical approach to solving scientific problems.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, address complex scientific challenges, drive technological innovation and support patients in need.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.