Sr. Director - External Operations

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Job description

Role: Sr. Director, Head of External Operations

Location: Fully remote, with travel expected at 25-50% domestically as well as Europe and Japan

Role is remote with travel to HQ in San Rafael, California up to 6 times per year.

Type: Full-time/Permanent

Responsibilities:

The Sr. Director, Head of External Operations, GEO will provide leadership for all manufacturing and packaging operations which take place in Contract Manufacturing locations globally to support clinical pipeline and commercial product portfolio. The core focus of the role is to ensure timely delivery of quality commercial and clinical product to support patient supply from our CMO network. Our CMO operations span multiple sites (approx. 20) and multiple technology platforms, including Biologic Drug Substance, Synthetic Drug Substance, Oral Solid Dose, Sterile Drug Product, Combination Products, and Packaging.

Primary Activities:

Ensure delivery of quality product on time from our CMO network to support clinical and commercial supply plans, proactively resolving issues that escalate from Process Teams.

Partner with MSAT, External Quality, and Partner Management team to oversee & support product launch programs, tech transfers, technical changes, labeling updates, etc.

Manage the trade-offs & risks between longer-term strategic programs & day-to-day supply activities.

Develop the Operations model supporting the teams as they look to standardize work, eliminate waste, and focus on cross-functional working relationships to ensure product supply.

Recruit, onboard, & train operations professionals to ensure the team has the appropriate experience & capabilities to provide oversight across the E2E pharmaceutical value chain.

Manage career development & succession planning for external operations teams.

Manage CMO performance and develop the CMO relationship through routine cycles of Business Review Meetings (BRMs), Quality Review Meetings (QRM), and Joint Steering Committee (JSCs) Meetings as well as ad hoc visits as needed.

Lead our strategic roadmap to deliver against agreed targets (e.g., lead time reduction, cost reduction, metrics enhancements).

Partner with Quality, Site Supply Chain, MSAT, and others to develop cross-functional goals to drive continuous improvement (Quality, Cost, Delivery, Customer Service) in CMO Operations.

Represent CMO Operations in the Sales and Operations Planning process.

Lead development and management of CMO Operations budget and long-range plan (approx. $200m+ annual spend).

Support the CMO selection process by evaluating CMO capabilities against applicable manufacturing, quality, and compliance requirements and needs - both operational capabilities & strategic objectives.

Support development of strategic partnerships with CMOs.

Partner with Compliance, Legal, and Procurement teams to negotiate Master Supply Agreements with beneficial terms.

Proactively manage and communicate operational risks across the CMO network and develop mitigation plans in partnership with other functional leaders.

Develop risk-based strategies for the CMO operations oversight, considering the product life cycle, complexity, and CMO capabilities.

Develop CMO Operations team to ensure we continues to attract, retain, and engage key talent.

Qualifications/Experience:

Bachelor's degree in a Life Sciences, Chemistry, Chemical Engineering, or Pharmaceutical Engineering discipline required.

Minimum of 15 years of relevant biotechnology or pharmaceutical industry experience within operations, quality, or supply chain.

10+ years of direct experience in a GMP manufacturing environment and 7+ years of team leadership.

Direct and broad experience in GMP manufacturing across multiple platforms (biologics, synthetics, oral dose, parenteral manufacturing, packaging).

Experience overseeing multiple product launch / NPI / Tech Transfer programs.

Experience with regulatory agency inspections (e.g., FDA, TGA).

Previous experience leading global teams in multiple locations.

Strong leadership track record and experience in operations management with CMOs or internal operations.

Demonstrated ability to hire, coach, and grow leadership talent.

Experience in developing, implementing, and leading a cross-functional operations model.

Strong focus and passion for Operational Excellence and Continuous Improvement.

Track record of delivery on operational improvements across Quality, Cost, Delivery, and Customer Service.

Strong leadership track record especially in the areas of leading in a global and matrix environment, working cross-functionally, and developing talent.

Excellent written and verbal communication skills at all levels in the organization.

Experience managing department budget / spend.

Ability to travel to CMOs up to 25-50%, when required.

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