Director/Sr. Director of Drug Product CMC
Company: EPM Scientific - Phaidon International
Location: New York
Posted on: March 8, 2025
Job Description:
Director/Sr. Director of Drug Product CMCLocation: New York
City, NYCompany Overview:We are partnered with a dynamic
clinical-stage biotechnology company focused on developing
innovative therapies to address unmet medical needs. They are
dedicated to advancing science and improving patient outcomes
across several treatments and therapies.Job Summary:The
Director/Sr. Director of Drug Product CMC will lead and oversees
drug product development, manufacturing, and regulatory activities
to ensure high-quality products are delivered from early
development through commercialization. This role involves
cross-functional collaboration to support product lifecycle
management, process optimization, and regulatory compliance for
drug products, ensuring all CMC strategies align with company goals
and regulatory standards. The Director/Sr. Director will provide
technical and strategic leadership, working closely with internal
teams and external partners to meet critical project milestones.Key
Responsibilities:
- Lead the development and implementation of CMC strategies for
drug product development and manufacturing.
- Oversee technology transfer to and from contract manufacturing
organizations (CMOs) and provide technical oversight of drug
product manufacturing.
- Ensure compliance with cGMP regulations and manage quality
assurance activities, including deviation management, batch record
reviews, and lot disposition.
- Develop and manage risk-based strategies for CMO oversight,
considering product lifecycle, technical complexity, and CMO
capabilities.
- Collaborate with cross-functional teams, including Quality
Assurance, Regulatory Affairs, Clinical Development, and Supply
Chain, to ensure timely delivery of drug products.
- Support regulatory submissions by providing CMC-related
documentation and expertise.
- Lead process optimization, validation, and continuous
improvement initiatives.
- Manage the drug product manufacturing budget and long-range
planning.
- Serve as a subject matter expert during regulatory inspections
and audits.Qualifications:
- Ph.D. or Master's degree in Pharmaceutical Sciences, Chemistry,
Chemical Engineering, or related field, with 10+ years of
experience in CMC and drug product development (or equivalent
industry experience for those with a Ph.D.).
- Strong knowledge of cGMP regulations, ICH guidelines, and CMC
content of regulatory submissions.
- Proven track record in CMC regulatory submissions (IND,
NDA)
- Experience managing CMOs and overseeing technology transfer
processes.
- Excellent problem-solving, project management, and
communication skills.
- Ability to work collaboratively in a fast-paced, dynamic
environment.
- Familiarity with quality-by-design (QbD) principles,
statistical analysis, and DOE.
- Willingness to travel as needed (up to 10%).What We Offer:
- Opportunity to lead in a dynamic, fast-growing company with a
strong pipeline of innovative therapies.
- Collaborative work environment with professional development
and career growth opportunities.
- Competitive compensation package, including comprehensive
benefits and stock options.
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Keywords: EPM Scientific - Phaidon International, New York , Director/Sr. Director of Drug Product CMC, Executive , New York, New York
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