Job Title: Scientist III, Upstream

Location/Division Specific Information: Carlsbad-CA

At Microbial Material Services (MMS), a new Business Unit within Thermo Fisher Scientific’s Pharma Services Group, 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

In this role you 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.

A Day in the Life

• Perform Upstream small- and large-scale fermentation process development activities.
• Serve as project lead on multiple programs, regularly presenting with customers, assisting in project planning and timeline development, and participating in technology/process transfer.
• Design and conduct experiments for the development or optimization of upstream processes, applying proven understanding in production using mammalian and E. coli cells, with knowledge of DoE and statistics.
• 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.
• Communicate experiment and production schedule, as well as fermentation standard procedures and safety rules to trainees, if assigned, and other team members. Lead all aspects of, hands-on, critical production activities to ensure appropriate and compliance execution.
• Identify and implement various efficiency improvements for processes and equipment.
• Conduct technical investigations of production runs, resolve root cause and provide solutions to various issues in upstream process development. Document investigation and solutions in investigation reports.
• 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 Upstream Process Development production activities, to ensure that process and project objectives are achieved in a timely manner.
• Maintain various cell lines for process development purposes, process scale up and non-GMP toxicological lots.
• Participate in the development and/or optimization and implementation of new processes in the Upstream PD laboratory. Write and/or revise PDPRs, SOPs and RMS, as needed.
• Harmonize with FB Supply Chain Leader and when important, vendors (raw materials, equipment, and reagent supplies, validation, calibration and maintenance activities through the Facilities Department. or independently) on a regular basis to discuss needs and requirements including supply availability, delivery and installation timelines, etc.
• Work in collaboration with Quality Assurance, Quality Control, Manufacturing, MST, Supply Chain, Facilities and Project Management to achieve the departmental goals and objectives.

Keys to Success

EDUCATION

• Bachelors in Life Sciences, Engineering, Biochemistry, Biology or related field with 6+ years of industry experience
• Masters with 2+ industry years; or Ph.D - with industry experience preferred
  

EXPERIENCE

• Experience in large scale (> 100L) upstream production using bacterial cells, with knowledge of DoE and statistics.
• In-depth understanding of cell biology, including aseptic manipulations in a cleanroom environment is desirable.
• Validated understanding of modern laboratory procedures, virology is a plus.
• Small- and large-scale fermentation process development, preferably in a CDMO
• Experimental design, and analyzing and presenting data

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.

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. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. please visit www.thermofisher.com