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Technical Operations - CMC Project Leader (Director) 

JOB ID: 2018 CMC Project Leader 

 

Job Detail
 

Reporting to the Chief Technology Officer / Head of Technical Operations, the Technical Operations - CMC Project Leader will lead cross-functional technical teams and key initiatives as we build-out the company’s clinical development and manufacturing capability.  The individual will help shape the company’s manufacturing & supply strategy and will be responsible for operational execution of strategic projects and programs. 

 

The ideal candidate brings a passion for leading diverse technical teams to drive breakthrough innovation and possesses expertise managing technical projects in multiple areas including: IND / BLA CMC development, manufacturing and analytical method transfers, process optimization, CMO & supplier management, and manufacturing facility start-up.

 

Responsibilities
 

  • Lead cross-functional technical teams to deliver CMC Development, Manufacturing, Quality, and Supply Chain projects supporting clinical development, product launch & commercialization and be accountable for:  project planning & execution, project governance, team management, and project budgeting & financial reporting.

  • Support and / or lead Technical Operations long-term planning and decision analysis, for example: technology, manufacturing, and supply chain development plans; make vs. buy analysis, cost analysis; and facility / capacity planning.

  • Ensure Technical Operations milestones are integrated within program timelines and be accountable to the program team for delivery of Technical Operations commitments. 

  • Identify, assess, communicate, and escalate technical project risks throughout the product lifecyle.  

  • Effectively communicate project status within project & program teams, to executive management, and to key internal and external  stakeholders.
     

 Basic Qualifications
 

  • Bachelor’s degree in a related life sciences or engineering field is required; an advanced degree in a scientific, engineering, or business field is desirable.

  • Minimum of 10 years of life sciences experience with 3-5 years of prior experience as a project manager leading cross-functional CMC / Technical Operations teams.

  • Prior experience leading technical transfer teams.

  • Prior experience with biological drug development; cell & gene therapy product development experience strongly preferred.

  • Comfortable in a fast-paced, collaborative small company environment, working with minimal direction and able to adjust workload based upon changing priorities.

  • Demonstrated leadership skills and the ability to collaborate with and effectively influence others. 

  • Strong attention to detail, excellent oral and written communication skills, and able to communicate effectively throughout all levels of the organization and with external partners.

  • Demonstrated experience with project management tools, techniques, and IT applications.

  • Preferred Qualifications

  • Project management certification.

  • Operational Excellence/Lean Six Sigma training & experience.

  • Subject matter expertise in a related functional discipline such as Manufacturing, Quality, Supply Chain, Engineering, or Process / Analytical Development.

  • Experience managing direct reports.

 

Department
 

  • Technical Operations

 

Location
 

  • Fulltime, based in East Norriton, PA

  • Will require travel to Tmunity offices in Philadelphia (~25%)

Tmunity is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

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Tmunity Therapeutics Inc.
3020 Market Street, Suite 535
Philadelphia, PA 19104

+1 215 966 1600

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