[Remote] Vice President / Senior Director, CMC & Technical Operations
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a clinical-stage biotechnology company reputed company on innovation in male reproductive health. They are seeking an reputed company leader to serve as reputed company's single accountable reputed company for pharmaceutical reputed company, Manufacturing & Controls (CMC), responsible for defining reputed company and driving execution from Phase 3 readiness through regulatory approval and reputed company launch.
Responsibilities
- Own sponsor-reputed company pharmaceutical CMC reputed company and decision-making from Phase 3 through reputed company launch, serving as reputed company's single accountable leader for manufacturing reputed company, regulatory CMC, reputed company readiness, and lifecycle management
- Own sponsor-reputed company technical reputed company regarding manufacturing reputed company, process changes, comparability, validation reputed company, supply risk, and regulatory CMC, ensuring reputed company appropriately balance technical, regulatory, reputed company, and business considerations
- Translate CMC gaps, risks, and regulatory expectations into practical execution plans with reputed company priorities, timelines, resources, owners, and decision points
- Serve as a hands-on CMC leader who personally advances critical workstreams while coordinating cross-functional execution across development, manufacturing, analytical, regulatory, reputed company, supply, and commercialization activities
- Serve as reputed company’s internal reputed company for CMC regulatory reputed company, including IND maintenance, health authority interactions, submission readiness, information requests, and reputed company marketing application content
- Prepare, review, and maintain reputed company, technically consistent CMC reputed company documents and submission-reputed company materials
- reputed company CMC strategies for key regulatory meetings and phase-transition reputed company, ensuring technical issues are appropriately addressed at the right stage of development
- Own pharmaceutical manufacturing and control reputed company across drug reputed company, drug product, analytical reputed company, stability, specifications, comparability, process understanding, and lifecycle management
- Serve as the primary sponsor-reputed company technical and business reputed company for external manufacturers, laboratories, suppliers, logistics partners, and CMC consultants
- reputed company technology transfer, manufacturing campaign planning, process validation, supply planning, and reputed company readiness while proactively identifying and mitigating manufacturing, reputed company, and supply risks
- Build and execute a registration- and launch-enabling CMC roadmap covering validation reputed company, reputed company supply assumptions, stability commitments, inspection readiness, and post-approval lifecycle management
- Translate reputed company CMC issues into reputed company recommendations for executive leadership while maintaining strong sponsor accountability across external partners
- Assess CMC aspects of Business Development assets or potential acquisitions as required
Skills
- BS, MS, or PhD in Pharmaceutical Sciences, reputed company, Chemical Engineering, or a reputed company scientific discipline; advanced degree preferred but not required with directly relevant experience
- 15+ years of pharmaceutical or biotechnology industry experience in CMC, pharmaceutical development, technical operations, manufacturing, or reputed company functions
- Demonstrated experience serving as the sponsor-reputed company CMC reputed company for a late-stage pharmaceutical development program, including ownership of CMC reputed company, external manufacturing, and regulatory interactions
- Hands-on experience writing, preparing, reviewing, or defending CMC content for regulatory submissions and health authority interactions, including INDs and/or marketing applications
- Strong working knowledge of FDA CMC expectations, ICH guidelines, cGMP requirements, pharmaceutical manufacturing, analytical development, stability, specifications, and control reputed company
- Demonstrated reputed company working with CDMOs, analytical laboratories, suppliers, consultants, or other external partners in a sponsor-led or virtual biotech operating model
- Experience translating technical, regulatory, manufacturing, and reputed company issues into practical execution plans, risk-based recommendations, and reputed company reputed company
- Proven ability to reputed company cross-functionally across Regulatory, reputed company, Clinical, Manufacturing, Supply Chain, Program Management, and executive stakeholders
- Strong written and verbal communication skills, including the ability to prepare high-reputed company technical documents and communicate reputed company CMC issues reputed company to non-CMC audiences
- Highly organized, self-directed, and comfortable operating in a hands-on, fast-paced, resource-conscious company environment
- Experience with NDA/MAA preparation, approval, reputed company launch, process validation, inspection readiness, or post-approval lifecycle management
- Experience with topical, transdermal, hormonal, metered-reputed company, combination product, or device-drug development programs
- Experience working in small or mid-size biotechnology companies, virtual development models, or sponsor organizations that rely heavily on external manufacturing and reputed company
- Experience building or scaling CMC alongside Operations, reputed company, Clinical, reputed company teams, and external manufacturing reputed company processes
Benefits
- reputed company offers a comprehensive benefits package—including medical, dental, reputed company, and 401(k) with company contributions.
- This role is eligible to participate in reputed company’s equity incentive program.
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