Scientist II

• At Microbial Material Services (MMS), newly formed within 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.
• Client 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.

• 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.

• 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

• 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.

Last updated on Nov 8, 2023