Description:
Job Description Title: Scientist II Location Specific Information: Carlsbad-CA At Microbial Material Services (MMS), newly formed within Thermo Fisher Scientifics Pharma Services Group, we deliver, from process development through commercial supply, the expertise and resources critical 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 innovative 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. * Helps in design and conducts experiments for the development activities. * Generate and assists in analyzing data, prepare experiments/data for presentation, and prepare and modify documents (development plans, batch records, SOPs, protocols, summary reports), including deviation and/or investigational reports. * Maintain laboratories and production rooms according to the companies high compliance standards including review of completed records, equipment logbooks and maintenance records. * 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. * Supports technical investigations of production runs, resolve root cause and provide solutions to various issues in process development. Document investigation and solutions in investigation reports. * Helps to 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 Process Development production activities, to ensure that process and project objectives are achieved in a timely manner. * Participate in the development and/or optimization and implementation of new processes in the PD laboratory. Write and/or revise PDPRs, SOPs and RMS, as needed. * Maintain accurate record of materials used for experiments and bank productions. * Source cGMP compatible raw materials for processes. * Aid in the sourcing, purchase, installation, startup and calibration and maintenance of Process Development equipment. * 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 3+ years of proven industry experience * Masters with 1+ years industry experience; or Ph.D, with industry experience preferred EXPERIENCE * Upstream production (fermentation) or Downstream purification experience. * If Downstream, necessary experience includes: experience and knowledge of biological separation processes including filtration (such as UFDF, NF, VRF), chromatography (such as affinity, IEX, SEC, HIC), and ultracentrifugation. Preferred experience: purification process development of plasmids. * If Upstream, required experience includes: knowledge of aseptic procedures, maintaining production cultures, cell banking, media formulation, and harvest techniques. Preferred experience includes: transfection and production of plasmids.
Skills:
fermentation, aseptic technique, production cultures, cell banking, media formulation, harvest techniques, transfection, production of plasmids, mRNA
Additional Skills & Qualifications:
• Upstream production (fermentation) or Downstream purification experience. • If Downstream, necessary experience includes: experience and knowledge of biological separation processes including filtration (such as UFDF, NF, VRF), chromatography (such as affinity, IEX, SEC, HIC), and ultracentrifugation. Preferred experience: purification process development of plasmids. • If Upstream, required experience includes: knowledge of aseptic procedures, maintaining production cultures, cell banking, media formulation, and harvest techniques. Preferred experience includes: transfection and production of plasmids.
Experience Level:
Intermediate Level
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
Actalent is an equal opportunity employer.
About Actalent
Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.
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