Associate Director – Commercial Freeze Drying Support (Hybrid)

Job Description

The Global Animal Health Manufacturing (GAHM) Biotechnology Solutions (BTS) group is seeking a highly motivated individual to serve as a leading scientific expert providing guidance, recommendations and judgment for strategic technical issues and decisions pertaining to the following domains – commercial freeze drying (lyophilization) and fill-finish.

You will join our Bio-Technology Solutions (BTS), Large Molecule Technology Stewards group that supports scoping, planning of network manufacturing operations at a strategic-level within our Manufacturing Division. The Associate Director is expected to serve as a leading scientific expert providing strategic guidance, recommendations and judgment for technical issues and decisions pertaining to freeze drying equipment, technology-transfer of inline cycles and broader aseptic fill-finish technology with regards to Global Animal Health Manufacturing (GAHM) strategy. This position will not have employee management responsibilities.

Primary Responsibilities

• Ensure proper design, installation, qualification of commercial freeze dryers in line with current industry best practices.

• Ensure a robust first principles-based tech-transfer strategy for inline products across the GAHM manufacturing sites and identify opportunities and design optimal FD cycles aimed at productivity gains.

• Provide technical/scientific guidance and oversight to the Animal Health Large Molecule strategy team, regional operation team and engineering teams involved in capital investment, technology transfer, and operational readiness to ensure scientific rigor.

Additional Responsibilities

• Build and maintain strong and trusting relationships with our Manufacturing Division and Global Engineering leadership, and other stakeholders to ensure effective communication for scoping, planning and change management.

• Stay abreast of scientific developments and trends in fill-finish domain and participate in external industry/regulatory forums to maintain an industry-leading level of subject proficiency resulting in continuous improvement culture.

Minimum Education and Qualifications:

• Bachelor of Science or equivalent in a technical or scientific discipline such as Biology, Chemistry or Chemical Engineering

• Seven (7) years of relevant work experience in the pharmaceutical, biotech, or related industry in guiding equipment design, installation, and qualification of capital freeze dryers in a new sterile facility in a pharmaceutical, biotech, or related industry.

• Experience in analysis of commercial lyophilization processes for vaccines/large molecules/small molecules, either in development, operational or in technical support role.

• Strong scientific understanding of vaccine and/or biologic products and processes and their effective integration with relevant regulatory/GMP requirements.

Preferred:

• PhD or advanced degree with specialization in a subject pertinent to vaccine/large molecule manufacture

• Ability to collaborate effectively, across functional boundaries, to align stakeholders and sponsors on technical strategies.

• Demonstrated problem solving, effective verbal and written communication, and people management skills.

• Proficiency with pharmaceutical industry technical business processes:  change control, deviation management, technical protocols/reports, and regulatory license documents. 

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