Associate Director, CDMO Alliance Management

🕒 6 days ago

🏖️ New Jersey – Remote

🏖️ New Jersey – Remote

💵 $169.2k - $253k / year

⏰ Full Time

🟠 Senior

👔 Director

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Otsuka Pharmaceutical Companies (U.S.)

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

💊 Pharmaceuticals

🏥 Healthcare

🧬 Biotechnology

Pharmaceuticals • Healthcare • Biotechnology

Otsuka Pharmaceutical Companies (U. S. ) is a prominent player in the pharmaceutical manufacturing industry, dedicated to creating innovative products for better health worldwide. The company comprises two main entities: Otsuka America Pharmaceutical, Inc. (OAPI), which is focused on commercializing Otsuka-discovered and in-licensed products in North America, and Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), which specializes in the clinical development and global registration of innovative healthcare solutions, particularly in the field of neuroscience.

📋 Description

• Serve as the central point of contact and business partner for CDMOs, ensuring alignment between partner actions and company goals • Contract Negotiation to structure agreements, manage terms, and collaborate with legal and internal stakeholders • Standardize Governance and Business Review structure with CDMO executive leadership to ensure long-term collaboration • Define, set, and monitor key performance indicators (KPIs) to hold CDMOs accountable for delivery and quality • Support comprehensive risk assessments focused on stable supply chains and quality assurance at partner sites • Facilitate discussions and drive the implementation of improvement measures based on KPI performance data and identified risks • Conduct business-side assessments during GMP audits led by the Quality Team to ensure commercial and operational viability • Support the internal decision-making process regarding new CDMO selections and major capital investments • Act as the lead for cross-departmental coordination when major incidents occur • Collaborate with internal departments to identify supply risks stemming from regulatory shifts, demand volatility, or manufacturing deviations, and lead the execution of countermeasures at the CDMO level

🎯 Requirements

• Bachelor’s degree in Science, Engineering, Business, or a related field (MBA or advanced degree preferred) • 8–12+ years of experience in alliance management, strategic sourcing, or external manufacturing within the pharmaceutical or biotech industry • Proven ability to influence and collaborate with cross-functional stakeholders in a complex, matrixed organization • Strong background in risk management, business continuity planning, and performance analytics (KPIs) • Exceptional negotiation and communication skills • Knowledge of CDMO landscape and manufacturing processes across one or multiple modalities (e.g., small molecule, biologics, sterile fill-finish, etc.) • Thorough knowledge of GMPs (CFR title 21, parts 210-211 and Part 600), along with EU, MHRA and other global health authority regulations • Strong, proven supplier relationship management skills • Negotiation and contract management skills a plus

🏖️ Benefits

• Comprehensive medical, dental, vision, prescription drug coverage • Company provided basic life, accidental death & dismemberment • Short-term and long-term disability insurance • Tuition reimbursement • Student loan assistance • A generous 401(k) match • Flexible time off • Paid holidays • Paid leave programs as well as other company provided benefits