Sr CMC Project Manager

About Sonoma Biotherapeutics:

Sonoma Biotherapeutics is a South San Francisco and Seattle-based clinical-stage biotechnology company developing engineered regulatory T cell (Treg) therapies to treat serious autoimmune and inflammatory diseases by restoring balance to the immune system. Founded by pioneers in Treg biology and cell therapy, the company brings together leading expertise and proprietary methodologies for the discovery and development of disease modifying and curative therapies. Sonoma Bio has initiated two Phase 1 studies to evaluate the safety and proof-of-mechanism of the company’s lead Treg cell therapy candidate, SBT-77-7101, in patients with rheumatoid arthritis and hidradenitis suppurativa. The company has a partnership with Regeneron to discover, develop and commercialize novel regulatory T cell therapies. More information at www.sonomabio.com.

The Senior CMC Project Management will lead Sonoma’s CMC PM activities across the portfolio, from pre-IND through all stages of development.

This person will be responsible for the direction, coordination, implementation, control and completion of projects, while remaining aligned with company goals, strategy and commitments. They will manage CMC teams of process development, manufacturing, regulatory and quality specialists to achieve CMC goals, while working in close partnership with the Technical CMC Project Leads, and maintaining close alignment with Program Team Leads and Program Managers.

This person will act as business lead for external CDMO vendors. They will work closely with both Technical CMC Project Leads and Finance to ensure efficient CDMO management.

The Senior CMC PM will be responsible for developing, implementing and using fit-for-purpose PM practices, tools and templates, informed by industry best practices. This position requires facilitation and enabling strong collaboration between the CMC team, other internal functions, and external CDMO vendors. Must have the ability to work in a highly matrixed and cross-functional organization, against tight deadlines, and with external partners, suppliers and business leaders alike.

This position will be based in Seattle, WA, however remote and hybrid candidates will be considered. The position will require travel on occasion to CDMOs and other CMC vendors as needed for project objectives and timelines.

Specific Job Responsibilities

• Work closely with CMC team, internal collaborators, and external CDMO vendors to ensure accurate tracking and timely completion of project deliverables in support of corporate goals.

• Facilitate planning and management of CMC activities across drug substance, drug product and clinical supply chain to align dependencies, schedules, and delivery commitments with overall program needs and vendor capabilities.

• Provide PM support for CMC and supply chain activities to support development, manufacturing tech transfer, manufacturing, disposition, and shipments of drug substance and drug product, analytical method development and transfer, stability, and supply chain related activities. This includes the identification of drivers for budgets, resources, project work plans, and timelines.

• Develop and execute integrated detailed project work plans and revise as appropriate to meet changing needs and requirements.

• Identify individual resource requirements and portfolio capacity needed. Work with departmental heads and external clients to identify and assign individual responsibilities.

• Create, manage, and facilitate meetings, including the development of agendas, issue written minutes, and drive action items to completion.

• Monitor and maintain project metrics on budget, schedule, resource allocations, issues, risks, and scope change to ensure project performance.

• Proactively communicate key issues and any other critical topics in a timely manner to the appropriate internal and external stakeholders, including executives, partner functions and other teams/team members.

• Develop and communicate clear performance expectations; monitor and observe performance of project team members; provide clear and timely feedback and escalate to resource managers when appropriate.

• Evaluate and recommend improvements to current processes and systems to enhance efficiency and effectiveness.

• Partner closely with Program Management function to establish and maintain integrated Pipeline Program Timelines across the portfolio. Champion best practices in Project Management, including the use of dashboards, templates, tools, and proceses to drive efficiency and alignment.

• Travel, as required, to CDMO’s and other CMC vendors.

Experience and Skills

Required

• A bachelor’s degree in Biological Sciences, Bioengineering, Chemistry or an associated discipline and 5+ years of biotechnology or drug development experience.
• Experience with cell therapy programs
• Proficiency in Project management and/or PMP certification
• Expert knowledge of Smartsheets and proficient in MS Office
• Track record of delivering in a fast-paced, innovative, dynamic environment while remaining flexible, proactive, resourceful, and efficient.
• Outstanding organizational skills.
• Excellent written and oral communication skills.
• Working knowledge of US and European regulatory requirements.
• Ability to work on site in Seattle, WA to interact with key team members.

Preferred

• Strong CDMO vendor management track record
• IND / BLA management/coordination experience.
• Strong technical understanding of inter-disciplinary nature of drug development, contract manufacturing, analytical development, document control, technology transfer, and CMC regulatory filings.
• Experience in a GMP environment; both drug substance and drug product manufacturing in prescription drug setting.