CMC / Technical Operations Program Manager - Associate Director

Sobi • San Diego, CA

3d • Hybrid

About The Position

The CMC / Technical Operations Program Manager - Associate Director is responsible for leading an international cross-functional technical CMC team, associated functions like Quality and impacted CMO/CLOs to deliver all required technical documentation supporting an approvable NDA Module 3 and translate technical & regulatory strategies into execution. This role involves project managing all key CMC deliverables, including underlying reports, coordinating team interactions, ensuring structured and purposeful team meetings, documenting clear decisions/actions, and communicating them to team members and relevant stakeholders. The position also assures integrated program plans are in place, including cross-functional interdependencies, facilitates the setting and tracking of program objectives and priorities, monitors program progress against approved project plans, and coordinates the identification and mitigation of program issues and risks. Additionally, the role builds holistic, scientifically sound scenarios as decision proposals at all governance levels, coordinates the review process of technical documents, and prepares for governance and executive management program presentations. The individual is responsible for program budget and long-term projections, including budget planning and tracking, evaluating project resource requirements, highlighting resource gaps, and confirming invoice execution to the budget owner. Other job-related tasks may also be assigned.

Requirements

• 10+ years of pharmaceutical industry experience
• Significant hands-on experience in CMC Development and Program/ Project Management roles in complex environments
• Experience in working with cross-functional teams in the pharmaceutical industry, preferably in a global setting
• Excellent Project management skills: Decision- and action-oriented to facilitate quick decisions in alignment with all stakeholders, with ability to organize, prioritize and follow-up
• Experience in managing detailed program timelines to ensure timely delivery of key milestones and keeping oversight on complex projects budgets).
• Identify and evaluate risks associated with project activities and take appropriate actions to control or mitigate risks.
• Scientific and technical background of CMC development and manufacturing in drug substance small molecule, no-sterile products.
• Demonstrable experience of working in cross functional team with ability to multitask, prioritize and be an effective decision maker
• High level of flexibility and effectiveness in cross-functional, international, and cross-regional environments.
• Proven ability to adapt to an ever-changing business environment.
• Fluent in English
• Strategy and operational excellence minded with the ability to quickly define key program priorities, risks and issues, and lead teams in focusing on urgencies and solutions of greatest importance
• Outstanding relationship building and communication skills, including ability to navigate throughout the organization and with individuals at all levels both internally and with external partners
• Ability to lead, manage, develop, and motivate others in a matrix organization and in a changing environment
• Structured and analytical

Nice To Haves

• Intermediate to full proficiency in Chinese is a plus.

Responsibilities

• Lead an international cross-functional technical CMC team, associated functions like Quality and impacted CMO/CLOs to deliver all required technical documentation supporting an approvable NDA Module 3 and translate technical & regulatory strategies into execution.
• Project manage all key CMC deliverables, incl underlaying reports, coordinate team interactions ensuring team meetings have structure and purpose, documents clear decisions/actions and communicates them to team members and relevant stakeholders, holds team members accountable for functional delivery of plans
• Assure integrated program plans are in place including cross-functional interdependencies, in particular: Facilitates the setting and tracking of program objectives and priorities and monitors program progress against approved project plans (ensures we deliver on time and on budget)
• Coordinates the identification and mitigation of program issues and risks, assures risk mitigation plans
• Build holistic, scientifically sound and relevant scenarios as decision proposal at all governance levels
• Coordinate the review process of technical documents (ie, protocols, reports, master and executed batch records, change controls, deviations, etc.)
• Coordinates the preparation for governance and executive management program presentations in close collaboration with the leadership team
• Responsible for program budget and long-term projections – budget planning and tracking, and evaluates project resource requirements: highlights resource gaps and works to ensure they are addressed
• Follow the invoices and confirm the corresponding work execution to the budget owner
• Other job related tasks

Benefits

• Competitive compensation for your work
• Generous time off policy
• Opportunity to broaden your horizons by attending popular conferences
• Emphasis on work/life balance
• Collaborative and team-oriented environment
• Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments
• Eligible for both short-term and long-term bonuses
• Competitive benefits package

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: No Education Listed