Associate Director, CAR-T Analytical Research & Development - Warren, NJ | Biospace
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Associate Director, CAR-T Analytical Research & Development

Celgene

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Location:
Warren, NJ
Posted Date:
9/22/2017
Position Type:
Full time
Job Code:
17001141
Salary:
Required Education:
Doctorate/PhD
Areas of Expertise Desired:

Job Description

Description

Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health.  We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

Summary:


Key leader for analytical development and assay validation functions within Cell Therapy Development & Operations (CTDO). Will design and lead cross-functional analytical development programs to drive the rapid advancement of cellular therapy candidates from pre-clinical through commercial manufacturing. Provide a strategic direction for analytical method lifecycle management for cell therapy product development. Provide scientific guidance to the CTDO QC function.

Responsibilities will include, but are not limited to, the following:

1. Direct activities of the CTDO Analytical R&D function, consisting of analytical scientists and bioengineers. Ensure the development and training of staff.

2. Lead analytical development programs in support of the development, characterization, validation, GMP implementation and scale-up of ex-vivo cell expansion processes.  

? Lead the selection, development and validation of analytical methods to assess cellular product identity, purity, safety, quality and potency.  

? Coordinate and lead various aspects of method transfer, characterization, trouble-shooting and assay validation while collaborating with QC, Process Development, Clinical and Commercial Manufacturing, and Quality Operations.

? Design, develop, oversee and implement validation protocols for methods relating to cellular product identity, purity, safety, quality and potency, including both in-house and external supplier testing.

? Interpret Quality Control guidance documents for processes and analytical methods and FDA, EMA and GMP requirements to design release testing panels and direct development efforts.

3. Provide scientific guidance to the QC team.

4. Maintain current awareness of GMP/GTP and other regulations, guidance documents, advisory committees, industry standards and trends that are applicable to current and future CTDO operations and products. Communicate this to other staff, as appropriate, and provide key strategic compliance and analytical development input to projects and cross-functional teams, including process development, manufacturing implementation, IMPD and IND preparation, discussions with regulators, etc

5. Interact extensively with Process Development, Quality Operations, Manufacturing, Translational Development and other personnel as dictated by project need.

6. Direct activities of technical group of ~5 research associates. Balance resource allocation to project priorities.

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Requirements

Qualifications

Skills/Knowledge Required:

• PhD in Biological Science, Biochemical Engineering, or related discipline with 5 yrs R&D / analytical development experience, or MS with 10+ yrs R&D / process development experience for biologics.

• Established track record of success, sound technical qualifications and knowledge in analytical method development. Cell therapy product characterization, comparability testing, flow cytometry and cell-based assay experience a plus.

• Solid understanding of the fundamentals of assay validation and tech transfer.

• Familiarity with and constant attention to the evolving landscape through literature, conferences, etc.

• Strategic thinker with excellent problem solving and conflict resolution skills.

• Ability to foster a strong team-first environment with the ability to lead multiple projects.

• Self-motivation, excellent time management, organizational, written and oral communication skills.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.