Job: Process Lead - Chemistry, Manufacturing, and Controls (CMC), Precision BioSciences, Durham, NC
Process Lead - Chemistry, Manufacturing, and Controls (CMC)
Durham, NC 27701 United States
Manufacturing and Production
Research and Development
The Process Lead, CMC will be a key member of the Development team and will develop and implement operational excellence in the development, manufacturing and controls of our Cell and Gene Therapy products during clinical development phases and in preparation for commercial launch.
The Process Lead will work closely with Manufacturing, Process Development, Quality Control and Regulatory Affairs to define and implement the manufacturing strategy for Precision’s gene and cell therapy products The individual will be responsible for technical oversight of manufacturing units (CMOs and in-house manufacturing), leading process technology transfers and ensuring timely procurement of high quality starting materials (plasmids, cell banks) and cGMP grade drug intermediates, drug substance or drug products in keeping with project timelines and budget. The Process lead will also be involved in the definition and execution of process validation activities needed in the preparation of applications for licensure. The Process Lead will also provide conceptual guidance and expertise to Precision’s Development Team and contribute to continuous process optimization and characterization throughout the entire product development lifecycle.
The ideal candidate will have extensive experience and knowledge in development and manufacturing of clinical and commercial complex biologics. They will have a proven track record of successful technology transfers and GMP manufacturing of clinical trial material and will have been directly involved in late stage process validation programs in preparation for licensure. This role is highly complex and applies knowledge of CMC development and broad manufacturing expertise (upstream/downstream process steps, drug substance and drug product). The ideal candidate will have experience working in Process Developments teams, GMP Manufacturing operations/MSAT and in close interaction with Quality Assurance, Quality Control and Regulatory Affairs. The candidate must have a high level of independence to carry out their responsibilities with minimal supervision.
Essential Duties and Responsibilities
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. This list contains the major duties and requirements of the job and is not all-inclusive. Incumbent(s) may be expected to perform role-related duties other than those contained in this document. Manage programs at vendors and CMOs for the procurement of key starting material, drug substance and drug products.
Manage and supervise Process Technology Transfer activities (including personnel training) and technical oversight during of manufacturing unit(s) during manufacturing campaigns.
Work collaboratively with Manufacturing, Quality Assurance and Quality Control to ensure timely manufacturing and release of GMP compliant mRNA and AAV material.
Coordinate process trouble shooting, investigations, root cause analysis, CAPAs, impact assessment and change controls.
Author and/or review manufacturing documentation (e.g. Protocols, Process Description, Batch Records, SOPs, Change Controls, and manufacturing campaign summary reports).
Contribute to the writing and review of IND/IMPD filings.
Contribute to the definition and execution of process validation.
Provide engineering input and support to Process Development teams.
Conduct risk assessment (FMEA, critical Process Parameter identification) and COG analysis with to revise and optimize process control strategy and identify key areas of process optimization.
Contribute to the writing of SOPs (e.g. SOPs, protocols, reports) to meet global regulatory expectations, as required
Perform other related duties as assigned.
MS or Engineering degree in Chemistry, Mechanical, Chemical or Biological Engineering, or equivalent
5+ years of biopharma process development and/or manufacturing experience of complex biologics
Excellent working knowledge of GMP and GLP requirements.
Must have a good understanding of Quality Systems and demonstrates proficiency in application of QA principles, concepts, industry practices, and standards. Good conceptual, strategic, analytical, problem solving, and organizational skills.
Autonomous, take-charge, proven team player with a strong results orientation, positive “can do” attitude, and a sense of urgency to get things done.
High emotional intelligence, sound temperament and professional attitude.
Excellent communication skills, both verbal and written, and the ability to interface effectively with all level of the organization. Strong communication skills with outside contract organizations is required.
Fully versed with Microsoft Office software suite, DOE software such as JMP or Minitab, project management software such as Microsoft Project or Smartsheet, and process simulation software such as Aspen Batch or SuperPro.
Personal alignment with Precision’s values, mission and vision.
Do you know someone who would be interested in this job?