What You’ll Do
- Conducts lab and pilot plant experiments
- Generates and coordinates execution sampling protocols
- Serves as subject matter expert (SME) to lead and conduct troubleshooting, process impact assessments, and executes root cause analysis (RCA) and corrective and preventive action (CAPA) in response to deviations
- Executes and analyzes lab and pilot plant work aimed at solving complex manufacturing problems
- Leads and supports technology transfer (TT) across multiple unit operation
- Coordinates, plans, and executes manufacturing process validation runs
- Supports design and leads generation of sampling plans for process validation reports (PVRs) and investigations
- Writes and reviews master batch records (MBRs) and standard operating procedures (SOPs), as needed
- Generates and executes process training and consults on topics related to manufacturing and process
- Leads technical risk assessments for new manufacturing processes
- Contributes to the management of manufacturing data (i.e., databasing) and the statistical analysis aimed at both process monitoring and continued process verification
- Writes documentation for internal and external use, such as manufacturing campaigns summary reports, process performance qualification (PPQ) protocol and reports, impact assessments etc.
- Leads training of manufacturing staff and process sciences group on new processes, procedures, and use of equipment in the lab
- Interprets and utilizes new knowledge to promptly drive data-based decisions
- Collaborates with the manufacturing department to support commercial and clinical manufacturing campaigns, including on-floor support
- Leads continuous improvement projects within unit operations, in partnership with manufacturing when applicable, to improve manufacturability, reliability, yield and cost
- Supports supplier technical evaluations, risk assessments, and raw material evaluation and qualification
- Other duties, as assigned
Knowledge and Skills
- Proficient knowledge in Design of Experience (DOE)
- Proficient knowledge in Statistical Process Control
- Effective communication, both written and oral
- Ability to effective present information to others
- Proficient project management skills
- Advanced problem-solving skills
- Ability to provide feedback to others, including leaders
- Ability to develop effective working relationships internally and externally
- Ability to adapt communication style to differing audiences and advise others on difficult matters
Basic Requirements
- Associate degree in Engineering, Life Science or Chemical Engineering with 8 years related work experience (e.g., manufacturing); or
- Bachelor’s degree in in Engineering, Life Science or Chemical Engineering with 6 years of related work experience (e.g., manufacturing)
- Master’s degree with 3 years of related work experience; or
- PhD with no prior experience
- Large scale manufacturing support experience with chromatography for several types of chromatographic mediums operations, viral
filtration, ultrafiltration, and bulk filling, troubleshooting, and deviation support - Experience using quality systems (e.g., deviation management system, change control, CAPA, document management system)
- Experience using risk management and RCA tools
Preferred Requirements
- Experience in contract manufacturing or interacting with contract manufacturers
- Experience working in a Good Manufacturing Practices (GMP) environment
- Prior drug substance and manufacturing experience, including process development, validation, and transfer
WORKING CONDITIONS & PHYSICAL REQUIREMENTS
Will work in environment which may necessitate respiratory protection X No Yes
May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. X No Yes
Will work in environment operating a motor vehicle or Powered Industrial Truck. X No Yes
Ability to discern audible cues. No X Yes
Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. X No Yes
Ability to ascend or descend ladders, scaffolding, ramps, etc. X No Yes
Ability to stand for prolonged periods of time. X No Yes
Ability to sit for prolonged periods of time. X No Yes
Ability to conduct activities using repetitive motions that include writs, hands and/or fingers. X No Yes
Ability to operate machinery and/or power tools. X No Yes
Ability to conduct work that includes moving objects up to X pounds. X No Yes If yes, 10 lbs. 33 lbs.
Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions. X No Yes