Share with friends or Subscribe!

Process Lead - Chemistry, Manufacturing, and Controls (CMC)

Department: Development
Location: Durham, NC

Summary

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.

Qualifications

The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully.

Education/Experience

Work Environment

The work environment characteristics described here are representative of those an employee could potentially encounter while performing the essential functions of this job.

Physical Demands

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.

Travel Requirements

Precision BioSciences’ mission and vision is to translate the world’s 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. Precision’s 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.

Applicant Tracking System Powered by ClearCompany HRM Applicant Tracking System