BE - CMC Project Manager - Drug Development

Johnson & Johnson Worksense (via Randstad Sourceright) is responsible for finding, engaging and contracting talent for the Johnson & Johnson contingent workforce.

Currently we are looking for a CMC Project Manager who will be responsible for a small portfolio of Janssen vaccines for a one year project.  

RESPONSIBILITIES:

The CMC Project Manager will:

• Provide CMC Team Support and represent “CMC PM” at the PMT Team.
• Translates the CMC strategy into realistic and executable CMC deliverables with clear assumptions based on CMC & Commercial input.
• Supports risk management process, specifically identification and development of mitigation strategies with CMC team & PMT.
• Works out scenarios to support decision making in line with CMC, JSC and CDT strategy.
• Manages the CMC end-to-end process from pre-NME through launch.
• Proactively plans and manages the cross-functional project deliverables that support the CMC development and Commercial Launch:
• Works in close collaboration with the CMC Leader, SI’s, JSC New Product Team(NPT) and Commercial Lead.
• Active follow-up on the progression of all CMC activities required to successfully launch product.
• Monitors CMC driven key milestones, decision points and critical path activities.
• Owns the CMC schedule in V6, including creation, monitoring and maintenance from pre-NME through launch.
• Resource (FTE & OOP) & Budget Management in close partnership with Functional Planning and Program Coordinators · Represent CMC and JSC at the PMT.
• Works in close collaboration with the CDT Program Management Leader (CDT-PML) to ensure alignment of the CMC strategy with the CDT strategy.
• Works in close collaboration with the PMT Program Managers to ensure alignment of functional strategies with the CMC strategy.
• Proactively identifies areas of need within the department and works to mitigate them.
• Identify, develop and implement best practices related to CMC, PMT and NPT Teams.
• Proactively outline new processes and supports the integratration of enabling technologies into the team setting to drive efficiency.
• Help ensure organizational readiness to support project execution (talent, training, etc.).
• Work with line management to address gaps in current cross-departmental processes and organizational structures.

PRIMARY DUTIES:

• Program and Strategic Planning.
• Operations Management and Leadership.
• Product development & Submission Management and Oversight aligned to customers.
• Program Information/Communication Management.
• Program Timeline, Resource, and Cost Management .
• Additional requirements may be identified.

EDUCATION REQUIREMENTS:

• Bachelor, Master, PharmD, or PhD degree in a pharmaceutical, life sciences, or business subject.
• Professional project management certification or degree is a plus.

EXPERIENCE REQUIREMENTS:

• 8 - 10 years of industry/business experience, including at least 4-6 years in the pharmaceutical industry.
• Experience with CMC development is a must.
• Experience required in areas such as manufacturing, active pharmaceutical ingredient, drug product development, CMC regulatory, analytical development, etc.
• A working knowledge of drug development is required.
• Experience in developing a health authority dossier is a plus.
• Experience with planning software and visualisation tools (MS Project) is a plus.

EXTRA INFORMATION:

• https://prezi.com/view/HuosOeuKPr8n5tcreZiJ/
• Flexible working hours.
• Because of COVID-19, you will work fulltime from home.
• This is a long term contracting position, with the possibility of an extension after the end date. You wil receive a contract via our partner Randstad Professionals. They can offer you a contract of indefinite duration, a project contract for the duration of the assignment at J&J or a freelance contract.