Scientist III, Process Development

Location/Division Specific Information

• Carlsbad-CA
• At Microbial Material Services (MMS), a new area within Thermo Fisher Scientific’s Pharma Services, we deliver, from process development through commercial supply, the expertise and resources vital to help clients deliver innovative plasmid-based therapeutics as critical raw materials, drug substances, and drug products. Placed in the forefront of our leading- and ground breaking Cell and Gene Therapy businesses enabling clients to cure genetic, rare, and otherwise untreatable diseases as their CDMO of choice.

Discover Impactful Work!

Work will work alongside clients to design, develop and optimize processes that produce Plasmids for CGT and/or mRNA vaccines These Plasmids are used to treat or cure patients of life threating diseases.

What will you do?

You will drive Downstream Process Development (DSPD) activities to deliver a scalable manufacturing process to its clients for the purpose of producing Plasmid material for clinical or commercial use. This includes design and execution of the purification process and researching/sourcing reagents, equipment, and materials for specific activities related to the process. You will also technically review data, collaborate with customers on data and experimental design, prepare documents and experiments, participate in investigations, and optimize purification methods. Work closely with Manufacturing and MST personnel to ensure that the process developed in PD is optimally transitioned to clinical Manufacturing.

• Perform Downstream small- and large-scale process development activities.
• Identify and implement various efficiency improvements for processes and equipment. Provide expertise for equipment and processes within functional responsibility and assist in the equipment/process transfer to cGMP Manufacturing.
• Prepare status and development/production reports, participate in daily and/or weekly team meetings, and communicate issues and progress to site and PD leadership. Coordinate and report production outcomes for Downstream Process Development production activities, to ensuring that objectives are achieved in a timely manner.
• Participate in the development and/or optimization and implementation of new processes in the Downstream PD laboratory. Write and/or revise PDPRs, SOPs and RMS, as needed.
• Maintain accurate record of materials used for experiments.
• Be a part of sourcing, purchase, installation, startup and calibration and maintenance of DSPD equipment.
• Serve as project lead on multiple programs, regularly collaborating with customers, assisting in project planning and timeline development, and participating in technology/process transfer and/or development.
• Design and conduct experiments for the development or optimization of downstream purification processes, applying proven understanding in filtration technologies, column chromatography, ultracentrifugation, and scale-up principles.
• Mentor, lead, and enable others to deliver objectives efficiently and with high degree of quality.
• Make project level decision on process development items including critical investigations and process improvement/optimization.
• Assist in maintaining the process development laboratory, including general lab upkeep, material and equipment inventory, maintenance, and organization, etc.
• Lead OpEx initiatives to improve Downstream and Process Development efficiency.
• Remains current in the field by review of relevant scientific literature and attendance at appropriate scientific seminars and conferences.

Keys to Success.

EDUCATION/ EXPERIENCE

• B.S. in Chem Eng, Biochemistry, Biology or related field with 6 yrs of meaningful related experience or Masters with 2 yrs or Ph.D. with 1 years
• Have a confirmed understanding of modern laboratory procedures, GLP compliance, and aseptic technique.
• Experience in Technical writing, critical thinking/troubleshooting, GDP compliance, data compilation and interpretation experience.
• Have Hands-on experience and knowledge of biological separation processes including filtration (such as UFDF, NF, VRF), chromatography (such as affinity, IEX, SEC, HIC), and ultracentrifugation is required. Experience with purification process development of plasmids or viral vectors is helpful.
• Have Hands-on experience in operating AKTA chromatography purification, TFF/UFDF skids, ultracentrifuges, and filtration assemblies.

COMPENSATION AND BENEFITS:
The salary range estimated for this position is $82,400 - $125,900. This position will also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. Actual compensation will be confirmed in writing at the time of offer.

We offer a comprehensive Total Rewards package that our US colleagues and their families can count on, which generally includes:
• A choice of national medical and dental plans, and a national vision plan
• A wellness program, and valuable health incentive opportunities for company contributions to a Health Reimbursement Account (HRA) or
Health Savings Account (HSA)
• Tax-advantaged savings and spending accounts and commuter benefits
• Employee assistance program
• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver
leave), accident and life insurance, short- and long-term disability, and volunteer time off in accordance with company policy
• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.

Salary : $82,400 - $125,900