Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.

At Viral Vector Services (VVS) a division of Thermo Fisher Scientific we deliver, from process development through commercial supply, we offer the expertise and resources necessary to help clients deliver innovative gene therapies. Placed in the forefront of our leading and cutting edge Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases.

Viral Vector Services is an experienced viral vector CDMO supporting gene and cell therapies, and is focused on process and analytical development, and clinical and commercial supply. With more than a decade of experience, our 500-strong, highly skilled team has managed over 100 client projects delivering first-in-human clinical materials to accelerate our client's products from the laboratory to patients in need. We work in close collaboration with each client's team to deliver successful programs. Through this, we enable the delivery of novel medicines to improve patient health with the potential to cure diseases.

The Viral Vector Service business within the Pharma Services Group enables biopharma customers to deliver life-saving gene and cell therapies to patients. ​This exciting addition strengthens our value proposition for pharma and biotech customers in a very fast-growing market. ​

Together with the acquisition of approximately 600 new VVS colleagues based in Massachusetts and Florida, we'll enable breakthroughs in science that improve patients' lives and bring hope for a healthier world!

How will you make an impact?

This position will work in the GMP compliant QC Laboratories to develop, qualify or validate, and conduct cell-based, nucleic acid-based, protein-based, and chemistry-based assays that support quality control of biopharmaceutical products being developed and manufactured. Will perform routine assays and testing including PCR, real time PCR, agarose gel electrophoresis, SDS-PAGE, immuno blotting, ELISAs, immunocytochemistry, and infectivity and reporter gene based cell assays using insect or mammalian cell lines. This position will also troubleshoot and optimize assays under the supervision of the GMP QC Technical Manager. Functions also involve maintenance of cell lines used in the QC laboratories, maintenance (routine and preventive operation) of equipment, and preparation and purification of commonly used biological reagent and chemical supplies. The incumbent will be expected to technically interpret, write controlled documents and reports, and review data produced by self and participate in laboratory investigations. Will interact with other departments to ensure that sample flow, supply chain, and equipment disposition are correctly maintained. Mentor technicians/ scientists to conduct/ develop these assays; write/ review cGMP reports/ documents and test records.

What will you do?

• Independently develop, qualify and/or validate assays.
• Perform Release and Stability testing according to written procedures and in compliance with cGMP regulations.
• Function as a subject matter expert for Analytical Assays.
• Attend internal and client facing meetings to provide technical feedback and support planning activities.
• Draft SOPs, Test Records, Assay Qualification Protocols and Summary reports and any supporting documents (Reagent Preparations, Equipment SOPs etc).
• Review data generated by reports and solve issues.
• Will mentor Scientists and Lab Associates.
• Provide input for performance appraisals.
• Order laboratory supplies and maintain required inventory according to SOPs
• Perform laboratory and equipment cleaning and preventive maintenance and calibration
• Perform analytical assays and cell line maintenance
• Other assigned duties could include sample logging and assisting with shipment preparations

Analytical assays performed would support GMP manufacturing activities and release testing. This position is a M-F 8am-5pm role. Flexibility and overtime may be required on holidays and weekends to support project timelines.

How will you get here?

• A Bachelor’s degree in Life Sciences or Chemical/Biological Engineering.
• A minimum of five years’ work experience within the biological and/or pharmaceutical industry.
• A graduate degree and appropriate hands-on college coursework may substitute at an equivalent rate for required experience.
• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
• Ability to speak effectively before groups of customers or employees.
• Laboratory documentation, reports, and correspondence

Knowledge, Skills, Abilities

• Electronic organizational skills using Microsoft Excel or other planning tools
• Ability to communicate/work in a high pressure/high paced environment
• Ability to multi-task and function effectively as a member of a team

At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

Apply today! http://jobs.thermofisher.com

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 origi