Title: Associate Director, CDMO Alliance Management (Princeton)
Location: Princeton, Nj, 08540, US
Company: Otsuka Pharmaceutical Co.
Position Summary:
The Associate Director, CDMO Alliance Management, GEM will serve as Otsuka’s representative and business partner toward our network of Contract Development and Manufacturing Organizations (CDMOs). This leader is responsible for the end-to-end lifecycle of partner management—from initial selection and complex contract negotiations to long-term strategic relationship building. The Associate Director ensures that the external manufacturing network is high-performing, risk-resilient, and fully aligned with Otsuka’s strategic business objectives.
Key Responsibilities:
Contract and Partner Management:
- Serve as the central point of contact and business partner for CDMOs, ensuring alignment between partner actions and company goals.
- Lead the identification and selection process for new CDMO partners and participate in all contract negotiations, including centrally managing the repository of all active agreements.
- Contribute to the Governance and Business Review meetings with CDMO executive leadership to ensure long-term collaboration.
Performance Monitoring and Improvement:
- 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.
Internal and External Coordination:
- 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, ensuring rapid resolution while daily operations remain with functional teams.
- 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.
Qualifications and Preferred Experience:
- Education: Bachelor’s degree in Science, Engineering, Business, or a related field (MBA or advanced degree preferred).
- Professional Experience: 8–12+ years of experience in alliance management, strategic sourcing, or external manufacturing within the pharmaceutical or biotech industry.
- Strategic Soft Skills: Proven ability to influence and collaborate with cross-functional stakeholders in a complex, matrixed organization.
- Operational Excellence: Strong background in risk management, business continuity planning, and performance analytics (KPIs).
- Communication: Exceptional negotiation and communication skills, with the ability to navigate sensitive partner relationships and internal executive reporting.
- Proven ability to work with international colleagues.
- 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