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 600+-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 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 manage development, qualification or validation work on cell-based, nucleic acid-based, protein-based, and chemistry-based assays that support quality control of biopharmaceutical products being developed and manufactured. The incumbent will be expected to drive the Assay Qualification/Validation work producing QC timelines and ensuring adherence to timelines to support client milestones. Additionally, 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?
- Manage and coordinate all Assay Qualification/Validation/Bridging work.
- Prepares/reviews/approves sampling plans, protocols, reports, data tables, test methods and writes SOPs. Writes URS for equipment commissioning
- Function as a subject matter expert for Analytical Assays.
- Attend internal and client facing meetings to provide technical feedback and support planning activities.
- Responsible for writing and reviewing investigations - invalids, minor and major events lab events and deviations, involved in investigations and troubleshooting
- Review data generated by reports and solve issues
- Will mentor Scientists and Lab Associates
- Collaborates with PM and technical leads from other cross functional areas to ensure clear expectations and successful deliverable
- Conducts resource modeling for team's projects, forecasting and resource and equipment allocation
- Acts as a functional group technical lead on multiple programs, with responsibility for running those programs within own functional group
- Regularly performs 1:1's with direct reports, coaching, mentoring and developing. Periodic 1:1's with indirect reports. Trains and mentors senior level scientists and supervisors.
- Coordinate tech transfer of methods and review all associated documents, including Tech Transfer protocols, SOPS, TRS, AQ/Val reports and protocols
- Drive functional, technical and operational excellence
- Responsible for continually improving the department via operational excellence initiatives, advances in technology, changes to regulatory landscape or other organizational changes
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.
- BS Degree in related field, 8+ years of experience or superior demonstration of skill sets or background.
Knowledge, Skills, Abilities
- MS Degree in related field, 5+ Years of experience or superior demonstration of skill set or background
PhD in related field, 4+ years of relevant experience or superior demonstration of skill sets or background.
- Experience in method development and validation under GMPs (ICH Q2R1)
- Experience in a QC GMP Laboratory, including documentation, reports, and exceptions
- Advanced skills in Electronic Sample management and quality systems
- 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
- Advanced knowledge on analytical, biochemical or cell based methods in Quality Control
- Excellent Leadership skills
- Ability to read, analyze, and interpret technical procedures, or governmental regulations
- 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
At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds have a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer.