Project Manager, CMC Technical Operations

Location
Durham, NC, United States
Posted
Sep 27, 2019
Ref
1145797
Hotbed
Bio NC
Required Education
Bachelors Degree
Position Type
Full time
Job Summary

The CMC Technical Operations Project Manager will be a key member of our Cell Therapy CMC team and will work with the CMC Technical Operations Leader to develop and implement operational excellence in the manufacturing processes of clinical and commercial products.

The CMC Technical Operations Project Manager will ensure that project goals and milestones are achieved by ensuring on-time procurement of IDPs/IMDPs to support non-clinical and clinical development studies in keeping with financial, regulatory and quality requirements. The Project Manager will manage several projects and multiple internal and external interfaces (e.g. contract manufacturing organizations and analytical contract laboratories) at the same time and ensure continuous and efficient interfaces during key development steps (technology transfer, conduct of development studies and manufacturing campaigns). The Project Manager may also be involved in the preparation of CMC documentation (SOPs, protocols and reports).

This role is highly complex and applies project management and knowledge of CMC development for complex biologics to ongoing partnerships. The ideal candidate will have experience working with Quality Assurance and Quality Management operations and 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.
  • Coordinate all cell therapy manufacturing, QC testing and stability studies for all Precision Biosciences cell therapy products to support non-clinical and clinical studies
  • Manage the supply chain, inventory and distribution of key material (e.g. banks, critical starting materials, drug products, samples) to ensure smooth project execution
  • Establish strong relationships with Precisions manufacturing and testing partners and ensure continuous and efficient interfaces by scheduling and coordinating meetings and communications
  • Deliver detailed status and performance tracking updates and communication of events in support of effective decision-making by management
  • Assist in the implementation of the CMC development strategy by developing detailed CMC development and manufacturing plans and timelines based on input from CMC and Tech Ops teams (this includes preparing Gantt charts for tracking process, formulation and analytical development as well as GMP manufacturing and QC testing)
  • Monitor changes in execution schedule and project requirements to anticipate and limit delays
  • Help to identify issues (technical, business and regulatory) and emerging risks and discuss work collaboratively with management and project team to devise appropriate mitigation plans
  • Maintain CMC Technical Operations project budgets (detailed budget forecast, purchase orders and invoices tracking) and update management on a regular basis
  • Provides document management and tracking support for all CMC-related documents supplied into the Precision Biosciences repository system
  • Contribute to the development the timely and thorough preparation of high-quality CMC documentation (e.g. SOPs, protocols, reports) to meet global regulatory expectations, as required
  • Performs 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:

Required:
  • Bachelor's degree in engineering, chemical, or biochemical sciences and 5+ years of related CMC project management experience or equivalent combination of education and experience.
  • 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
  • Proficiency with Microsoft Office software suite and project management software

Preferred:
  • Advanced degree and/or PMP certification
  • Lean manufacturing experience
  • Experience in development and manufacturing of biologic medical products (e.g. recombinant proteins, vaccines, cell therapy and/or gene therapy products)
  • Good understanding of Quality Assurance and Quality Management Systems to ensure adherence to cGMP and GLP requirement and SOPs
  • Good conceptual, strategic, analytical, problem solving, and organizational skills
  • Assertive, take-charge, proven manager, 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; good common sense and judgment
  • Outstanding project management and coordination capabilities
  • Personal alignment with Precisions values, mission and vision

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.
  • 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.

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.
  • 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.

Travel Requirements
  • This position may require travel (15%).

Location
  • This is an office-based position located at the main headquarters in downtown Durham, NC.


Precision BioSciences is dedicated to improving life through its proprietary genome editing platform, ARCUS. Precision BioSciences leverages ARCUS in the development of its product candidates which are designed to treat human diseases and create healthy and sustainable food and agriculture solutions. Precision BioSciences is actively developing product candidates in three innovative areas: allogeneic CAR T immunotherapy, in vivo gene correction, and food.

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.