Vice President, Chemistry, Manufacturing and Controls (CMC) - Fairway Consulting Group (Waltham)
Fairway Consulting Group
: $98,855.00 - $149,600.00 /year *
: Scientific Research
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Major tasks and responsibilities will include:
Designs and champions CMC roadmap for the company.
Establishes a drug substance and drug product strategy.
Collaborates with business development to negotiate contracts with CROs/CMOs.
Hires, retains, and leads all talent in the CMC function.
Designs and oversees relevant studies across the portfolio with regards to pharmaceutical development sciences.
Oversees, reviews, and authors, as appropriate, all relevant CMC sections for regulatory submissions to support product candidates.
Reviews study reports, manufacturing process documentation, investigator brochures, clinical study protocols, and clinical trial documentation for compliance with appropriate regulations and guidelines for CMC related issues.
Identifies execution risks and develops contingency plans as needed.
Partners with executive team in reaching timely, data-driven decisions with regard to CMC and drug manufacturing.
Establishes CMC operations for chemical development, formulation development, process development, analytical science, and supply chain.
Ensures robust planning and execution of product development efforts across the organizations portfolio of development stage product candidates.
Helps create and deliver to the overall R&D strategy and key priorities.
Encourages innovative, cross-functional thinking and engagement of outside expertise, as appropriate, to further help advance R&D goals.
Maintains a robust, longer-range CMC plan to support the broader organizational objectives and prepare the company for a potential product launch.
Ensures effective communication and alignment of efforts both within clinical operations and key internal and external partners.
Acts as liaison and provides support to team members that act as liaisons with the FDA and other regulatory agencies for CMC issues.
Works closely with organization partners and internal colleagues to ensure effective working relationships, and to proactively identify and mitigate risks to the conduct of work to advance products in a timely manner.
Develops and tracks CMC budget with finance.
Secures approval of changes arising throughout the year due to changing conditions and/or plans.
Performs on-site visits with key manufacturing providers as needed.
We seek candidates with the following qualifications:
PhD in pharmaceutical sciences, chemistry or engineering required.
Must have significant experience in the pharmaceutical industry.
Requires the demonstrated ability to be effective in an entrepreneurial, fast-paced environment.
Must have comprehensive understanding of all aspects of CMC including chemical development, formulation development, process development, analytical science, supply chain, regulatory, and quality for small molecule products.
Experience with injectable products is required.
Experience with oral products is highly preferred.
Requires experience with regulatory submissions and interactions with regulatory agencies regarding CMC issues at all stages of product development.
Must have a proven track record of successfully progressing drug candidates from IND through NDA submission.
Excellent analytical, communication, presentation, writing, and leadership skills is required.
Experience in writing CMC regulatory documents is highly preferred.
Associated topics: biochemistry, ceramic, chemistry, coating, formulation, glass, latex, material, polyurethane, rubber
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.