Associate Director/Director CMC Program Management

Santa Monica

Neogene Therapeutics is a pre-clinical stage biotechnology company aiming to change the treatment paradigm for solid cancers. Our mission is to provide cancer patients with T cell therapies targeting mutated proteins called neo-antigens, which are present on cancer cells as a consequence of DNA mutations. Neogene is developing novel technologies to enable the engineering of ‘designer T cells’ with neo-antigen specificities that display an optimized ability to seek and destroy cancer cells.

We are seeking a highly motivated and experienced Program Manager to join the CMC Technical Operations group. This position will ensure CMC Management and Operations for Neogene’s product portfolio and reports to the VP Technical Operations.

Responsibilities include, but are not limited to:

Drive development of CMC strategy in collaboration with CMC and program teams. Work with CMC and program team members to operationalize CMC strategy and integrate into the cross-functional program schedule.
Ensure operational plans are proactively tracked and highlight progress towards key milestones to ensure alignment of task dependencies associated with internal and external manufacturing activities. Responsible for efforts associated with process development, analytical development, manufacturing, quality, and supply chain
Contribute to program cross-functional working plans and timelines, help teams proactively identify and mitigate risks, and ensure sufficient resourcing to achieve program goals.
Responsible for the maintenance of requisite project documentation including detailed timelines, resource allocation and task prioritization to ensure delivery of the overall CMC plan and milestones
Utilize processes and tools including scenario planning, gap analysis, decision making and, risk management in collaboration with CMC team members, program teams and functional leads.
Provide CMC Project Management for both internal and external CMC development and manufacturing activities. Drive both internal and external timelines to ensure deliverables are achieved on time, within scope, and on budget.
Create, maintain, and articulate for various audiences detailed CMC project plans to ensure clarity of deliverables and timing including identifying drivers for each action item
Coordinate CMC development team, including scheduling and facilitating meetings, sending out agendas, writing and distributing meeting summaries, managing team documentation, and tracking goals and action items
Manage external CDMOs, including development of Statements of Work (SOW) contracts, oversee execution, track deliverables and timelines. Work with internal technical subject matter experts, supply chain, legal, finance as required.
Manage Tech Ops budget and headcount tracking. Work with Functional Leads and Finance to consolidate budget assumptions, estimates, and actuals.
Promote a culture of collaboration, cooperation, cross functional inclusion, execution excellence, effective communication and cross-functional problem-solving to become a high-performing team

Requirements:

10+ Years with BS/BA or 8+ Years with MS/MA or MBA in a relevant technical discipline such as chemistry, pharmaceutical sciences, biochemistry, molecular biology, chemical engineering or equivalent
A minimum of 5 years of experience in project management in pharmaceutical/biotechnology industry with first-hand understanding of drug development process, with prior experience in a CMC leadership role
Working knowledge of GXP, Quality Systems, and FDA regulations.
Excellent oral and written communication, interpersonal, analytical and computer skills, leadership and collaboration skills
Hands-on experience working in a CMC function
Working knowledge of Microsoft Project and other project management tools
Demonstrated strategic thinking capabilities with forward looking perspective
Leads without direct reporting responsibility by setting clear vision, respecting value of subject matter expertise, and empowering cross-functional team members to execute
Solid understanding of drug development, CMC, biologics manufacturing, and global operationsTranslates overall direction and strategy; communicates across organizational levels and functions.
Interprets and executes policies and procedures that typically affect subordinate organizational units. Recommends modifications to operating policies.
Serves as consultant to management and acts as a special external spokesperson for the organization on significant matters pertaining to its policies, plans, and objectives.
Develops solutions to a wide range of complex problems which require the regular use of ingenuity and innovation. Ensures solutions are consistent with organization objectives.

Additional Qualifications:

Pre-IND through clinical development experience is ideal
Relevant training (PMP or equivalent) is a plus

We offer the opportunity to join a highly dynamic growth-stage biotech company. You can expect a collaborative environment created by a team with deep scientific expertise and an industrial track-record in T cell therapies. We value pro-active team-players who pursue their goals with dedication, endurance and a daring mindset. If you share our commitment to make a difference to patients in need, we can provide a unique opportunity to be a major contributor to the success of a well-positioned, well-financed growth-stage biotechnology company. If you are interested, please submit your electronic application including cover letter and CV to careers@neogene.com

No recruiters. No phone calls.

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Associate Director/Director CMC Program Management

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