Associate Director, Technology Transfer

Description

• The individual should collaborate internally with Quality, Supply Chain, Regulatory Affairs and externally with CDMO to ensure timely and successfully project delivery at all stages.

Manage drug product technology transfer

• Coordinate with internal and external parties to establish tech transfer plan and project timeline
• Lead the collaboration with all relevant functions to implement and complete technology transfer activities and process validation
• Provide leadership in the resolution of both technical and nontechnical issues
• Track team activities and timelines to ensure that the deliverables are met timely
• Prepare, distribute, and present project status to team, management, and other stakeholders

Support commercial drug product manufacturing

• Collaborate with supply chain and quality to establish technical management to routine commercial manufacturing and maintain a status of control
• Provide technical expertise in scale-up, line expansion and new material source evaluation/qualification
• Lead investigation of technical issues and continuous improvements
• Provide timely communications to stakeholders and management
• Establish and maintain positive relationships with internal and external partners.
• Provide leadership to generate options to resolve problems, prioritize, decide appropriate courses of actions, and implement decisions.

Qualifications

• PhD Pharmaceutical Science / Chemical engineering / Medicinal, Physical, Analytical Chemistry, with 4+ years of industry experience, or MS with 6+ years of industry experience is required.
• Past experience in tech transfer and/or technical support at DP manufacturing site and/or manufacturing science is highly preferred.
• A deep understanding of pharmaceutical manufacturing processes is necessary along with ability to guide the generation and interpretation of formulation/process development data as it relates to the overall technology transfer.
• Successfully demonstrated ability to manage and influence internal and external stakeholders and resources.
• Prior supervisory experience is a plus.
• Strong written and verbal communication skills.
• Travel to the manufacturing sites in domestic and international region is required.