Sr. Process Development Scientist

An employer is looking for a Sr. Process Development Scientist to join their team in Carlsbad, CA. The employer is an enterprise company in the biotech industry and the Sr. Process Development Scientist will be joining a pharmaceutical services group. The group delivers, from process development to commercial supply, the expertise, and resources necessary to help clients deliver innovative plasmid-based therapeutics as critical raw materials, drug substances, and drug products. They are a CDMO providing leading- and cutting-edge Cell and Gene Therapy resources that enables their clients to cure genetic, rare, and otherwise untreatable diseases.

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.

Responsibilities:

* 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 solid understanding in production using 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 compliant 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 necessary, 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

* Bachelors in Life Sciences, Engineering, Biochemistry, Biology, or related field

* 5+ years of Upstream production (fermentation) OR 3+ years Downstream purification 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

* Small- and large-scale fermentation process development, preferably in a CDMO

* Experimental design, and analyzing and presenting data

Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.