Waltham, MA, United States
This is an outstanding opportunity to join a well-funded startup company early in its trajectory. The successful candidate will be a vital part of helping to achieve the **MEMBERS ONLY**SIGN UP NOW***., Inc. vision of transforming cancer therapies by attacking the tumor microenvironment through multiple pathways. We are seeking candidates who are passionate about improving human health through executing on efficient and effective operational goals, and who will participate in shaping the culture of a forward-thinking start-up company.
The Director, Chemistry, Manufacturing and Control (CMC) is responsible for the development and implementation of CMC manufacturing and regulatory strategies for DNA/RNA or small molecule drug substance and drug product. The position reports in to the Chief Development Officer.
Duties and Responsibilities
Oversee Contract Manufacturing Organizations (CMOs), including timeline, budget, quality and scope of CMC deliverables. Ensure technical solutions suggested by CMO are the best plan for each compound.
Accountable for the submission of high quality regulatory CMC documents to the FDA and health authorities in compliance with GMP and local authorities requirements.
Author regulatory CMC documents for IND submissions.
Manage and ensure compliance with all reporting requirements, including annual and periodic reports.
Assess and communicate CMC regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines.
Serve as CMC lead at internal meetings as well as at meetings with business partners and regulatory agencies for all CMC related issues.
Collaborate with contract staff and vendors as needed to support regulatory activities.
Partner with team to provide responses to and may interact with regulatory agencies/health authorities as needed
Provide creative and innovative solutions while being an advocate for compliance.
Proactive management of issues and information sharing with key internal/external stakeholders
May be asked to support drug supply chain planning.
Other responsibilities may be assigned to support program level activities as requested
Places a priority on getting results with an emphasis on high quality outcome
Participates in making timely, data-driven decisions
Develops and maintains effective working relationships with people across cultures
Actively seeks and receives coaching/mentoring; may provide guidance to junior members of team
Encourages collaboration across study teams, vendors, and geographies
Addresses conflicts in positive, solutions-oriented style
Displays a willingness to challenge the status quo and take risks
Responds resourcefully to changing business demands and opportunities
Other responsibilities may evolve over time and may not be limited responsibilities described here in.
Candidate must have 8 to 10 years of experience in CMC projects. Must have at least drug substance or drug product experience. Biologics, Protein Synthesis and Small Molecule experience preferred. Preferred experience in both drug substance and drug product.
Advanced degree (e.g., MSc, MD, MPH, PharmD or PhD) or equivalent education/degree in Chemistry, Biochemistry, or related pharmaceutical science is required
Strong knowledge of eCTD elements and structure and regulatory writing skills .
Experience in biotech/pharmaceutical industry with a demonstrated understanding of the interdependencies of research, technical development, GMP Manufacturing, Quality, Supply Chain, Preclinical, Clinical, Regulatory and Product Strategy functions.
Experience in overseeing CMOs (including project management and technical solutions)
Demonstrated ability to translate strategy into action;
Experience managing other people
Strong presentation skills
Proficient in MS Office and other computer applications
Strong communicator and good written/verbal skills in English; Speaking Chinese would be advantageous
Must be a highly motivated, thoughtful, independent, results-driven individual capable of functioning in a fast-paced collaborative environment
This is an office-based position that will require travel up to 15% time
Waltham, Massachusetts, 02451, United States
August 12, 2019
Director/Senior Director of CMC
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Other / Not Listed
Over 10 Years