CMC Project Lead

Lead the process development and GMP of novel mRNA vaccines and therapeutics, integrating strong project management skills with an extensive background in mRNA bioprocessing, molecular biology, and biochemistry. Manage multiple projects from bench to pilot scale, ensuring quality, compliance, and efficiency throughout the product lifecycle. Successfully provide project management, liaison CDMO partners, and regulatory consultants and agencies to fulfill phase appropriate mRNA vaccine DS/DP release within planned timelines.
The mRNA CMC Project Lead will be responsible for:

• Leading quality and process related activities to ensure the successful launch of mRNA projects.
• Representing Centivax as Lead on mRNA CMC Project teams
• Ensuring effective and efficient input to CMC teams
• Providing leadership and direction for work activities of partner representatives in mRNA CMC functions, and direct oversight and input to manage issues.

The candidate will have extensive background in mRNA vaccine process development, extensive CMC experience, and able to independently manage and support interactions with CDMO partner lines. The candidate will ensure alignment with current regulatory requirements and company expectations and will directly influence & evolve the strategy for future mRNA technologies through interaction with Health Authorities and use of compliance competitive intelligence. In addition, he or she will act as a primary interface with regulatory authorities (e.g. FDA) and/or CMO-based organizations for late-phase manufacturing compliance topics, including support for transfer to an industrial setting for launch. Cross-functional tasks to ensure CMC quality and timelines met for major partnerships with CDMOs will also fall under their responsibility.
The incumbent will work in a cross-functional, team-oriented organization with individuals from multiple R&D functions and CDMOs in different geographies and countries in order to meet DS/DP timelines for mRNA projects.
Direct interaction with R&D external partners and CMO organizations is a major part of the role and requires interface with CDMOs, plus appreciation for relationship building to support and enable vaccine business needs.
In this role you will:

• Lead Project management for mRNA CMC and supply chain activities to support development, manufacturing, release and shipments of drug substance and drug product, analytical method development and transfer, stability, and supply chain related activities
• Facilitate planning of regulatory related CMC activities across drug substance, drug product and clinical supply chain to align dependencies, schedules, and delivery commitments
• Create, manage, and facilitate regular meetings, including the development of agendas, issue written minutes, and follow up on action items
• Proactively communicate key issues and any other critical topics in a timely manner to the appropriate management level and/or to any other relevant project team member(s)
• Develop project plans with minimal support from others and works closely with project leads and/or CDMO and internal leadership
• Support CMC project leads and CDMO leads with the optimization of CMC project deliverables (schedules, resources, budgets)
   

Competencies / Requirements for position:

• BS or MS in science, pharmaceutical sciences or related field
• Minimum 8 years of experience in biologics CMC, and recent direct experience with nonGMP and GMP mRNA manufacturing. Experience in GxP Quality supporting pharmaceutical development, manufacturing, and testing
• Strong Project Management Skills
• Proven track record of critical thinking, flexibility, innovation, including the ability to manage priorities, track progress of key projects, and provide updates to leadership as required.
• Preferred experience with outsourced manufacturing and testing operations
• Preferred experience in working in compliance with US, EU and ICH GMP requirements, experience reviewing submission documentation, responses to regulatory inquiries and inspections
• Preferred experience with mRNA vaccines, nucleic acid-based and/or gene therapies, strong molecular biology background.
• Demonstrated ability to work independently, handle multiple tasks simultaneously, prioritize, negotiate and meet critical timelines.
• Strong interpersonal skills to effectively communicate with teams, peers, management and external contacts.
• Proven organizational and leadership skills to mentor and develop team to achieve Company goals. Demonstrated ability to effectively lead professional staff with at least 3 years experience.
• Working knowledge of MS Office products including Word, Excel, Outlook, PowerPoint, and Project.
• Must possess excellent organizational and communication skills.
• Thorough knowledge of preclinical, clinical and commercial product development. Post-market experience a plus. Technical knowledge of analytical method qualification, process validation and establishing product specifications.
• Rapid prioritization and decision-making for timely resolution of issues identified with the manufacturing or testing of clinical batches is essential, and decisions the individual may make are based on multiple sources of technical information that will require sound investigation and effective interpretation.
• The ability to negotiate and communicate in a positive manner, to discuss and address quality issues, anticipate globally the impact of known risks, and develop effective, pragmatic solutions is a requirement of the position.