Senior Director, CMC Project Management

POSITION SUMMARY

We are looking for a Senior Director of CMC Project Management who is upbeat, organized, self-motivated, collaborative, detail-oriented, and has a strong technical background and knowledge base.  The person filling this player/coach role will partner with the Head of Tech Ops, Biologics to provide strategic and operational leadership to the brelovitug CMC program, overseeing the development and implementation of integrated CMC plans from PPQ campaigns through global regulatory submission, approval, commercial launch, and lifecycle management activities. This role requires being able to prioritize to meet both short-term and long-term goals. This is a fantastic opportunity to make an impact, wear many hats, and be a part of an exciting growing biotech company.  This position is located in Foster City.

JOB FUNCTIONS/RESPONSIBILITIES

• Manage program CMC budgets and related contracts, partnering with internal Finance and Contract functions.
• Serve as the primary business lead for external partners, ensuring technical transfers,  manufacturing campaigns, testing, and other externally sourced activities stay on schedule and within budget.
• Maintain dashboards and reporting mechanisms for program status, risks, decisions, and critical path updates for team and senior/executive leadership.
• Facilitate cross-functional communications to gather inputs, align priorities, resolve conflicts, and share project updates; ensure clarity of owners, deliverables, and deadlines.
• Maintain an integrated program timeline identifying critical decision points, governance reviews, team events, and key milestones.
• Partner with Program Project Management to ensure appropriate integration with overall product strategy, timelines, and reporting, including alignment between development activities and portfolio-level planning as needed.
• Support preparation for governance reviews and executive program presentations, ensuring materials are accurate, aligned, decision-oriented, and delivered on schedule.
• Drive disciplined change control and documentation of scope/timeline changes, ensuring impacts are understood and communicated to stakeholders.

QUALIFICATIONS

Education /Experience:

• Bachelor’s degree; advanced degree (M.S., Ph.D, or MBA) preferred.
• At least 15+ years of work experience in the pharmaceutical/biotech industry with a significant focus on CMC project management for biologics.
• Experience managing relationships with biologics CDMOs.
• Able to effectively communicate updates, issues, and strategic solutions to problems.
• PMP (Project Management Professional) or equivalent accreditation is desired.

KNOWLEDGE, SKILLS, AND ABILITIES

• Strong interpersonal skills and ability to collaborate across functions; proven ability to influence without authority.
• Strong PM fundamentals (meeting management, timeline/critical path management, risk and issue management, decision tracking, action management, governance preparation).
• Proactive, forward-thinking, and able to anticipate needs in dynamic environments with competing priorities.
• Exceptional facilitation and communication skills (including executive-ready written and presentation skills) with success influencing at all levels cross-functionally.
• Strategic, able to identify long term needs and risks and to incorporate these into a long-term plan. Proven ability to make smart business decisions while balancing scientific, technical, and risk-based factors.
• Highly collaborative with outstanding relationship-building skills; ability to lead teams, navigate ambiguity, and resolve conflict effectively.
• Experience with project/portfolio management tools and systems and strong working knowledge of common collaboration tools (e.g., MS Office, Smartsheet, SharePoint).
• Willing to travel and to participate in teleconferences during non-business hours.

The salary range for this position is $270,000 to $300,000 USD. Compensation will be determined based on several factors including, but not limited to; skill set, years of experience, and the employee’s geographic location. Please note that the required compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits unless otherwise provided.

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