The CMC Technical Lead will be a key member of the Development team and will work in CMC Technical Operations to develop and implement operational excellence in the manufacturing and controls of our Cell and Gene Therapy products during clinical development phases and in preparation for commercial launch.
The CMC Technical Lead will work closely with Manufacturing, Process Development, Quality Control and Regulatory Affairs to define and implement the manufacturing strategy for non-viral and viral vectors (plasmid, mRNA and AAV 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 mRNA and AAV vectors (drug intermediates, drug substance or drug products) in keeping with project timelines and budget. The CMC Technical Lead will also be involved in the definition and execution of process validation activities needed in the preparation of applications for licensure. The CMC Technical Lead will also provide conceptual guidance and expertise to Precisions Development Team and contribute to continuous process optimization and characterization throughout the entire product development lifecycle.
The ideal candidate will have extensive experience and technical 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 vendors and CMOs for the procurement of key starting material (e.g. plasmids, MCB/WCBs) used in the production of mRNA and AAV vectors.
Manage and supervise Process Technology Transfer activities (incl. 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 technical 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 the Technical Operation SOPs (e.g. SOPs, protocols, reports) to meet global regulatory expectations, as required.
Perform other related duties as assigned
The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully.
MS or Engineering degree in Chemistry, Mechanical, Chemical or Biological Engineering, or equivalent
5+ years of biopharma process development or manufacturing experience of complex biologics (preference given to candidates with mRNA and/or AAV vector manufacturing experience)
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 Precisions values, mission and vision.
The work environment characteristics described here are representative of those an employee could potentially encounter while performing the essential functions of this job.
While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts; fumes or airborne particles; toxic or caustic chemicals and risk of electrical shock.
The noise level in the work environment is usually moderate.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
The employee must occasionally lift and/or move up to 25 pounds.
Specific vision abilities required by this job include close vision, color vision, peripheral vision and ability to adjust focus.
While performing the duties of this job, the employee is frequently required to stand; walk; sit; use hands to handle or feel, and talk or hear.
The employee is occasionally required to reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell.
Precision BioSciences mission and vision is to translate the worlds most powerful genome editing technology into greatly needed products throughout the life sciences, by being the conduit through which the greatest genome engineering challenges are solved. Precisions wholly proprietary ARCUS genome editing platform enables the production of highly specific nucleases that can insert, remove, and modify DNA at essentially any location in a complex genome. Through our ARCUS platform, we are developing genome editing-based products to address critical needs in oncology, genetic disease, agriculture, and beyond. For additional information, please visit www.precisionbiosciences.com
Precision BioSciences provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Precision BioSciences complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.