Director of CMC

2 weeks ago

Jersey City, United States Clinical Dynamix Full time

Director of CMC (Hybrid)


Company is seeking an experienced Director of CMC, to be based in their Jersey City, NJ offices 1 - 2 days a week (flexible schedule for the ideal candidate). They are committed to positively impacting the lives of patients by developing innovative therapies, come join them and make a difference.

Position Summary:


Reporting into the Head of CMC, the selected individual will be responsible for oversight of CMC operational, technical activities and strategies for drug substance and drug product development including analytical development/validation with support and oversight from the Head of CMC.The Director will collaborate with supply chain for management of clinical trial supplies (labeling/packaging, manufacturing.). The individual will provide expertise and leadership in the development and manufacturing of Company’s products in a fast-paced, multi-disciplinary environment. All Company’s development and manufacturing work is currently outsourced to external contract laboratories (CRO) and development & manufacturing organizations (CDMO).


Responsibilities:

Collaborate with cross-functional team leaders, including development, CMC regulatory, supply chain and quality assurance to ensure seamless execution of CMC strategies and activities.

With Head of CMC, lead the CMC core team multidisciplinary cross-functional team(s) to develop, manufacture, and supply Company’s novel drug substances and drug products, ensuring adherence to timelines, quality standards, and cost targets. Direct scale-up of fermentation, downstream purification, and synthetic manufacturing processes for drug substance candidates.

Responsible for technology transfer of drug substance manufacturing process including fermentation and downstream purification to CDMO and external partners.

Responsible for process characterization and validation strategy and execution.

Support drug product process development, manufacturing, and analytical development at CDMO’s

Collaborate with Company supply chain in assuring availability of materials for clinical and non-clinical studies.

Collaborate with Company Quality and Regulatory in assuring the materials for clinical and non-clinical studies meet quality and regulatory framework and guidelines.

Support and provide input into CMC strategy in partnership with Head of CMC, author drug substance sections for global regulatory filings, as well as other supportive development protocols and reports. Support authoring drug product sections.

Maintain relationships with various CRO’s and CDMO’s on various activities, i.e., project management, budgeting/invoicing, and oversee CDMO development operations.

Ensure compliance with global GMP guidelines and regulatory requirements, defined by FDA, EMA, and other global health authorities, for CMC activities.

Provide CDMO oversight through batch record review, deviation assessment, batch disposition.

Author study development reports, process characterization reports, transfer documents, and regulatory documents.

Support and represent CMC in due diligence activities with Head of CMC.

Assist with yearly CMC budgets along with Head, CMC and supply chain.

Work with project teams and management to communicate status of drug substance and drug product programs.

Stay updated in industry trends, technological advancements, and regulatory changes related to pharmaceutical development and manufacturing.


Requirements and Preferred Skills:

MS and/or PhD (preferred) in a relevant scientific discipline

At least 8 years of experience in all stages of drug substance and drug product development, including early and late-stage clinical development and preparation for product registration.

Experience leading cross functional teams, external third parties, and consultants with proven leadership capabilities to align, motivate, and empower cross functional team members.

Experience authoring and reviewing documents in support of CMC development activities and regulatory submissions (IND/IMPD, information requests, amendments, NDA / MAA etc.)

Experience working in an environment that strives to ensure internal technical expertise in-house while driving CDMO capabilities to meet milestones for multiple projects

Demonstrated critical thinking, problem solving, and innovation capabilities

Effective communication, collaboration, and negotiation skills

Ability to travel domestic and international as needed (Approximately 15%-20%)

Employment is contingent upon satisfactory results of a pre-employment background check, drug screen, proof of full COVID-19 vaccination and proof of COVID-19 booster vaccination.

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