Job Description
Beacon Hill Life Sciences is currently seeking a Director, CMC Lead (Consultant) .
Responsibilities :
- Lead a cross functional CMC team that drives all activities across process development, analytical, quality, regulatory, supply chain, manufacturing operations and clinical supplies
- Accountable for successful advancement of programs from a CMC perspective incl. meeting quantitative and qualitative program objectives and milestones
- Provide guidance and mentorship to the members of the CMC team. Maximize alignment, cooperation, input, decision making, commitment and synergy of CMC team members to ensure their technical contributions meet/exceed program objectives. Builds and motivates teams to become high performing, as well as works with functional leaders to identify and on-board team members as needed
- Ensures appropriate level of scientific and technical rigor, scale-up, and production strategies and timelines are in place to deliver successful clinical outcomes, meet clinical supply, and registration needs
- Represent the CMC function at the Core team level and act as the single point of contact to present high level CMC plans and strategies. Communicates effectively and transparently with functional representatives and stakeholders within Technical Operations, and other relevant stakeholders
- Ensure high quality and compliance of team deliverables and product supply through CMC deliverables.
- Align/collaborate with other relevant functions as e.g. external manufacturing, formulation and device development teams, to drive CMC strategy.
- Escalates/Informs functional leadership when additional assistance is needed
- Presents at governance committees and effectively communicate program-related updates to ensure alignment on proposed strategies to senior management and stakeholders.
- Provide committed and inspiring CMC leadership, stewardship, and advocacy, striving for knowledge development, continuous improvement, acceleration, risk assessment and mitigation, resource allocation and support, as appropriate.
- Collaborate with other CMC Leads and team members to enable alignment of key project strategies and tactics, establish best practices on CMC development and project leadership, and continuous learning
- Contribute to the management of overall program portfolio, including supporting capability build efforts across Technical Operations
Minimum Requirements:
- BS/MS with ≥15 years or PhD in a scientific field with ≥10 years of experience in product development; previous experience leading a cell therapy CMC team and interfacing regularly with CMC functions
- Demonstrated ability for critical thinking and innovation; highly motivated, willingness to acquire new skills and ability to work under ambiguous environment
- Ability to synthesize multiple inputs into key CMC deliverables
- Ability to engage and align other stakeholders outside the project team, and work effectively with cross-functional stakeholders in a complex / changing /global environment
- Excellent communication, writing, organization, and presentation skills
- Experience leading a group of individuals
- Strong technical qualifications and skills in current functional role
- Experience working in preparation of regulatory documents
- Interpersonal and leadership skills to work with teams consisting of different functions and organizations
- Ability to understand and communicate risks as well as developing and executing contingency plans for development programs
- Ability to manage ambiguity, and make sound scientific and business decisions with limited information (when necessary) to advance development efforts in a dynamic environment
- Ability to manage projects that have a potential combination of partnership/alliance or external effort
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