Associate Director- Analytical Sciences Expansion Partnerships

Job Description

This position is an individual contributor role serving as the primary point-of-contact for analytical technical activities at a localized External Entity (EE). Incumbent is responsible for technical oversight over the analytical testing at the Contract manufacturing (CMO) and/or Contract testing lab (CTL)) This position will require effective collaboration with external contract providers as well as colleagues in our research laboratories, process, supply chain, and global Quality, as well as CMC-Regulatory.

Responsibilities include but are not limited to:

• Provides analytical technical oversight of an EE involving releasing of products for further processing and/or final product release and stability testing.
• Collaborate across the internal network, external partners, international governments and/or CMO/CTL in the area of large molecule analytics.
• Proactive relationship management with the external testing labs
• Interface with Global Analytical Working Groups and Global Method Owners/SMEs
• Lead/support complex investigations and drive resolution of analytical technical issues
• Collaborating with EE and to support project start-up activities and provide analytical/technical support at the CMO and/or the CTL.
• Coordinate with analytical and process development groups to prepare for and coordinate analytical troubleshooting, validation and technology transfers between our Company, external partners and CMO/CTLs.
• Coordinate with EE for analytical gap analysis and risk assessments as part of method transfer activities.
• Provides support to the EEs to facilitate analytical testing readiness, including authoring/review of method validation and transfer protocols or reports.
• Build and maintain strong relationship with External Entities, as well as internal operations, technology, analytical and procurement organizations. Closely collaborates with appropriate business and functional areas to conduct Tier meetings, and Joint Steering Committee meetings (as applicable) to achieve our objectives.
• Authoring and/or reviewing technical documents to support Process Performance Qualification (PPQ), licensure and regulatory technical questions.

Minimum Education Requirement and Experience:

• Bachelor’s Degree in a Science or Engineering field. Minimum of six (6) years of experience in the field of analytical testing, development, transfer, and/or validation; OR
• Master’s Degree in a Science or Engineering field. Minimum of 4 years of experience in the field of analytical testing, development, transfer, and/or validation; OR
• Ph.D degree in a Science or Engineering field. Minimum of 2 years of experience in the field of analytical testing, development, transfer, and/or validation.
• Experience with large molecule GMP testing including drug substance and drug product release and stability testing, analytical laboratory operations, equipment, and techniques.
• Must be competent in analyzing complex product, production and testing issues and have demonstrated scientific problem-solving capabilities.
• Communicates in English, both verbally and in writing. 
• Must have strong interpersonal, communication, negotiation, and persuasion skills to build and manage relationships with multiple partners and stakeholders.

Preferred Experience and Skills:

• Strong project management skills
• Experience with analytical transfers and method validations for large molecules.
• Moderate level of contractual and financial awareness.
• Experience with Quality Risk Management, EE Oversight, Quality Management System and SOP management as well as metrics reporting experience.
• Writing or review of regulatory filings (IND, MAA, BLA, PAS, CBE) and inspections with multiple agencies (FDA, EMA, JNDA).

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Relocation:

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