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Director, Analytical Development 

JOB ID:

POSTED: 05/07/2018

 

Job Detail

The Director, Analytical Development is a key leadership role within our Technical Operations team, responsible for establishing and leading the company’s analytical science capability.  The individual in this role  will work collaboratively with Manufacturing, Process Development, Process Sciences, Regulatory, Quality, and Clinical team members to develop next generation analytical tools, manufacturing processes, and T-cell based therapies. 

 

The ideal candidate is an experienced leader with expertise in developing, optimizing, transferring, and qualifying assays to characterize T-cell based products and manufacturing processes, a demonstrated capability to build and lead a team of analytical professionals, and a strong desire to join an exciting, early stage T-cell development company. 

  

Responsibilities

  • Lead a team of scientists responsible for the development, optimization, qualification, and transfer of analytical methods for raw material qualification, product & process characterization and quality control.

  • Establish strong relationships and collaborate closely with the University of Pennsylvania and other partner institutions & companies to transition development programs to Tmunity Labs and to conduct ongoing joint development activities.

  • Provide analytical support (both internally & externally) to process development, characterization, validation, and tech transfer programs.

  • Identify talent and recruit, develop, manage and mentor a highly skilled team of analytical scientists.

  • Support the company’s business development and licensing activities and the  IP development strategy.

  • Author and review technical and scientific documents including but not limited to study protocols and reports, validation documents, SOPs, and test methods.

  • Provide CMC regulatory documentation required to support submission of analytical methods, characterization data, and release specifications.

  • Work with integrated program team to support IND enabling activities and participate as a subject matter expert for analytical method development and product characterization.

  

Basic Qualifications

  • MS / Ph.D. in a relevant discipline (immunology, biochemistry, cell biology, or related field).

  • Minimum 10 years relevant life science experience with prior direct experience in cell and gene therapy required.

  • Demonstrated track record with the development and/or commercialization of biotherapeutics.

  • Subject matter expertise and hands-on proficiency  with product and process characterization methods relevant to T-cell based products including, but not limited to flow cytometry, T-cell phenotyping, cell function characterization assays, PCR / qPCR, ELISA, and western blot.

  • 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. 

  • Excellent oral and written communication skills.

Preferred Qualifications

  • Experience authoring CMC sections of regulatory documents

  • Working knowledge of Quality Systems requirements

  • Familiarity with statistical software applications (e.g. Minitab, JMP)

 

Location

  • Fulltime, based in East Norriton, PA

  • Will require travel to Tmunity offices in Philadelphia and the University of Pennsylvania

  • Will require 10% travel out of state as part of duties with partners and conference attendance

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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3020 Market Street, Suite 535
Philadelphia, PA 19104

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