Director of CMC (Chemistry, Manufacturing, Control)

Job Reference: #78904 Add to saved jobs

  • Permanent
  • Sector Pharmaceuticals

Job Summary

About the job Job Description: Compugen is actively seeking a Director of CMC to lead our fast-growing proprietary programs in the clinical development stage, either directly (COM701 and COM902) or through partnerships, as well as new, original programs from our internal discovery engine. This position is part of the Preclinical Development Unit. The Director of CMC is responsible for establishing the CMC development plan, in accordance with Compugen’s defined global strategy, and ensuring its execution from pre-clinical through commercial development for all Compugen programs. Establish and lead the CMC development plans for drug substances and drug products from late research - preclinical stage through commercial development Maintain and enrich the existing portfolio of third-party contract manufacturers or vendors, including contract analytical laboratories, as required by the specificities of Compugen programs, and in close relationship with Quality and Regulatory functions Oversee contract parties related to all CMC functions, including USP and DSP manufacturing, technology transfer, process and analytical method development, optimization, characterization, qualification and validation testing, stability, release, comparability campaigns, regulatory filings, packaging and labeling operations. Guide associated operations, through or in association with a project manager when needed Contribute to internal cross-functional teams or with external partner(s) as a CMC functional representative Contribute to Compugen’s quality system documentation in the area of CMC, working with the Quality Assurance function Ensure that all internal and external CMC activities adhere to Compugen policies and relevant regulations Prepare international CMC regulatory filings and agency consultations, working with Regulatory and Quality functions Review CMC development and production plans that were prepared or adjusted by CMC project manager, to support preclinical, clinical, and commercial development Provide synthesis to management for any CMC questions in the form of reports or presentations as needed; ensure transparency to enable key strategic program decisions Maintain State-of-the-Art knowledge on CMC activities for biologics and propose implementation of new methods or technologies when emerging innovations may be beneficial for Compugen programs Job Requirements: Extensive scientific background (MS, PhD, Pharm.D or equivalent) in a discipline relevant to CMC, such as chemistry, biochemistry, protein engineering, molecular biology 5+ years of hands-on experience in contract manufacturing, biotechnology or the pharmaceutical industry Track-record of experience in direct management of key activities related to the CMC of biologics Exposure to Regulatory interactions, consultations or filings Ability and motivation to work and develop a team spirit with colleagues and external partners Experience and/or ability to work with external advisors Good understanding of GMP, FDA regulations and guidelines relevant to CMC of biologics. Exposure to other CMC regulations such as Europe would be an advantage Efficient analysis and synthesis of data Results-oriented; adept at facilitating problem solving This role requires some travel

Job Overview

About the job
Job Description:

Compugen is actively seeking a Director of CMC to lead our fast-growing proprietary programs in the clinical development stage, either directly (COM701 and COM902) or through partnerships, as well as new, original programs from our internal discovery engine. This position is part of the Preclinical Development Unit.

The Director of CMC is responsible for establishing the CMC development plan, in accordance with Compugen’s defined global strategy, and ensuring its execution from pre-clinical through commercial development for all Compugen programs.

Establish and lead the CMC development plans for drug substances and drug products from late research - preclinical stage through commercial development
Maintain and enrich the existing portfolio of third-party contract manufacturers or vendors, including contract analytical laboratories, as required by the specificities of Compugen programs, and in close relationship with Quality and Regulatory functions
Oversee contract parties related to all CMC functions, including USP and DSP manufacturing, technology transfer, process and analytical method development, optimization, characterization, qualification and validation testing, stability, release, comparability campaigns, regulatory filings, packaging and labeling operations. Guide associated operations, through or in association with a project manager when needed
Contribute to internal cross-functional teams or with external partner(s) as a CMC functional representative
Contribute to Compugen’s quality system documentation in the area of CMC, working with the Quality Assurance function
Ensure that all internal and external CMC activities adhere to Compugen policies and relevant regulations
Prepare international CMC regulatory filings and agency consultations, working with Regulatory and Quality functions
Review CMC development and production plans that were prepared or adjusted by CMC project manager, to support preclinical, clinical, and commercial development
Provide synthesis to management for any CMC questions in the form of reports or presentations as needed; ensure transparency to enable key strategic program decisions
Maintain State-of-the-Art knowledge on CMC activities for biologics and propose implementation of new methods or technologies when emerging innovations may be beneficial for Compugen programs

Job Requirements:

Extensive scientific background (MS, PhD, Pharm.D or equivalent) in a discipline relevant to CMC, such as chemistry, biochemistry, protein engineering, molecular biology
5+ years of hands-on experience in contract manufacturing, biotechnology or the pharmaceutical industry
Track-record of experience in direct management of key activities related to the CMC of biologics
Exposure to Regulatory interactions, consultations or filings
Ability and motivation to work and develop a team spirit with colleagues and external partners
Experience and/or ability to work with external advisors
Good understanding of GMP, FDA regulations and guidelines relevant to CMC of biologics. Exposure to other CMC regulations such as Europe would be an advantage
Efficient analysis and synthesis of data
Results-oriented; adept at facilitating problem solving
This role requires some travel

Skills Required

About the job
Job Description:

Compugen is actively seeking a Director of CMC to lead our fast-growing proprietary programs in the clinical development stage, either directly (COM701 and COM902) or through partnerships, as well as new, original programs from our internal discovery engine. This position is part of the Preclinical Development Unit.

The Director of CMC is responsible for establishing the CMC development plan, in accordance with Compugen’s defined global strategy, and ensuring its execution from pre-clinical through commercial development for all Compugen programs.

Establish and lead the CMC development plans for drug substances and drug products from late research - preclinical stage through commercial development
Maintain and enrich the existing portfolio of third-party contract manufacturers or vendors, including contract analytical laboratories, as required by the specificities of Compugen programs, and in close relationship with Quality and Regulatory functions
Oversee contract parties related to all CMC functions, including USP and DSP manufacturing, technology transfer, process and analytical method development, optimization, characterization, qualification and validation testing, stability, release, comparability campaigns, regulatory filings, packaging and labeling operations. Guide associated operations, through or in association with a project manager when needed
Contribute to internal cross-functional teams or with external partner(s) as a CMC functional representative
Contribute to Compugen’s quality system documentation in the area of CMC, working with the Quality Assurance function
Ensure that all internal and external CMC activities adhere to Compugen policies and relevant regulations
Prepare international CMC regulatory filings and agency consultations, working with Regulatory and Quality functions
Review CMC development and production plans that were prepared or adjusted by CMC project manager, to support preclinical, clinical, and commercial development
Provide synthesis to management for any CMC questions in the form of reports or presentations as needed; ensure transparency to enable key strategic program decisions
Maintain State-of-the-Art knowledge on CMC activities for biologics and propose implementation of new methods or technologies when emerging innovations may be beneficial for Compugen programs

Job Requirements:

Extensive scientific background (MS, PhD, Pharm.D or equivalent) in a discipline relevant to CMC, such as chemistry, biochemistry, protein engineering, molecular biology
5+ years of hands-on experience in contract manufacturing, biotechnology or the pharmaceutical industry
Track-record of experience in direct management of key activities related to the CMC of biologics
Exposure to Regulatory interactions, consultations or filings
Ability and motivation to work and develop a team spirit with colleagues and external partners
Experience and/or ability to work with external advisors
Good understanding of GMP, FDA regulations and guidelines relevant to CMC of biologics. Exposure to other CMC regulations such as Europe would be an advantage
Efficient analysis and synthesis of data
Results-oriented; adept at facilitating problem solving
This role requires some travel

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