Associate Director/Director, CMC Technical Operations

Location
Durham, NC, United States
Posted
Jul 08, 2019
Ref
1072669
Hotbed
Bio NC
Required Education
Masters Degree/MBA
Position Type
Full time
The Associate Director/Director, CMC Technical Operations 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 in preparation for commercial launch. This position will start as an individual contributor with strong potential for future team growth and oversight.

The Associate Director/Director, CMC Technical Operations will work closely with Manufacturing, Process Development, Quality Control, and Regulatory Affairs to define and implement the manufacturing strategy for Precisions 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 Associate Director/Director, CMC Technical Operations will be involved in the definition and execution of process validation activities needed in the preparation of applications for licensure. The Associate Director/Director, CMC Technical Operations 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 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.

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

Qualifications

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

Education/Experience:
  • Master of Engineering degree in Chemical, Biological, Mechanical Engineering, or related field
  • 8+ years of biopharma process development and/or manufacturing experience of complex biologics
  • Excellent working knowledge of GMP and GLP requirements
  • Good understanding of Quality Systems and demonstrated 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 levels 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 SuperPr
  • Personal alignment with Precisions values, mission and vision

Travel Requirements
  • This position will require travel (up to 20%)

Location
  • This position is located at the main headquarters located in Durham, NC and is required to physically be and work in the office, in order to be most effective, and at managers discretion.

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.