CDG Conseil, an executive search firm specialised in Life Sciences, is looking – for its client, a biotech driven by the goal of developing therapeutics that stimulate the body’s natural immune mechanisms to cure diseases – for a:
Senior CMC Project Manager
We are seeking a CMC senior project manager with a strong technical drug product development background to support our client’s Chemistry, Manufacturing, and Controls (CMC) programs to coordinate outsourced activities related to the development, launch and commercial manufacturing of drug substances and drug products in its portfolio.
The successful candidate will:
- Work closely with CMC leads in the Vendors (Contract Development and Manufacturing Organization) companies to provide project management support for ongoing development programs as well as planning of launch and commercial activities, coordination of regulatory filing activities, management of documentation, tracking of agreements and contracts as well as relevant technical documents, support of meeting scheduling.
- Ensure that CMC project management works seamlessly with the project management group and closely with Quality, Regulatory Affairs, CMC leads and others on the project team, as well as key external parties.
This position reports to the VP, Process Development and Manufacturing.
Essential Duties & Responsibilities
- Facilitate development and oversee execution of CMC and Technical Operations plans, including planning and execution of launch and commercial manufacturing activities.
- Integrate detailed execution and long-term development plans across the various CMC and Technical Operations areas, including Analytical Development, Chemical Development, Drug Product Manufacturing, Supply Chain, Logistics for a portfolio of projects
- Anticipate issues (technical, business, regulatory) and recommends mitigation for emerging risks.
- Schedule and coordinate CMC/Tech Ops team meetings, agendas and minutes
- Prepare plans and timelines based on input from CMC and Tech Ops teams
- Update and creates gantt charts; Tracks tasks and completion status
- Ensure alignment with cross functional team project managers; Provide clear directions to meet expectations of all stakeholders
- Manage CMC-related activities related to regulatory filings, budget tracking, quarterly accruals, long range planning, purchase request, invoices, contracts, agreements, technical reports, meeting scheduling.
- Assist with writing of product development documentation, technical reports, protocols, specifications, summary of technical data, or other as needed.
• Engineering Degree, Master of Sciences or Ph.D (preferably in Organic Chemistry) with +8 years’ experience in Pharmaceutical R&D or Technical Operations environment. Strong working knowledge of regulatory requirements for phase II/III stage product, product registration and commercial manufacturing.
• Strong track record of success in drug development (preferably NCE) and in understanding cross-functional interdependencies.
• Outstanding interpersonal skills and excellent oral and written communication skills
• Outstanding organizational skills.
• Detail oriented.
• Proven ability to excel in a matrix environment.
• Strong track record of enjoying the details without losing sight of the larger goals.
• Ability to multi-task and handle multiple projects simultaneously.
• Proven ability to effectively participate on multi-disciplinary project teams.
• Organizationally savvy. Strong initiative and desire to work in a fast paced, team-oriented dynamic environment.
• Able to thrive independently in a fast moving environment and working with limited support is required.
• Team-oriented, pro-active, and able to reinforce Company Culture and drive change where needed.
• English (advanced level) is a minimum.