ADC Technical Manager

• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
• There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
• Our client is developing the capability to produce all its medicines, helping to ensure continuity of supply of our medicines as they expand internationally.

• Lead and support NPI activities for product, processes and technology from early-stage development through to PPQ.
• Lead and manage cross functional teams across different skillsets and disciplines to perform activities required to deliver NPI's.
• Collaborate with cross functional teams including Process Development, Science & Technology (PDS&T), Quality, Manufacturing, Supply Chain and ECM to facilitate the smooth transition of new products from development to commercialization.
• Complete all site fit assessments for all the products from pipeline and ECM opportunities
• Provide technical direction and oversight and coordinate support for NPI activities across the entire biological manufacturing area
• Work closely with internal and external program management to ensure alignment on NPI schedules
• Ensure resource availability for all NPI related activities
• Build and maintain a mindset of innovation and continuous improvement withing the function.
• Provide leadership and mentoring for operations personnel during NPI activities
• Collaborate with external parties to ensure engagement and alignment and open communication throughout NPI activities
• Engage with external and internal partners to influence the design and implementation of robust process control strategies on process risk assessments
• Generate product transfer documentation to attest the completion of product transfer deliverables in advance of the application product transfer stage gate review

• Participate in NPI project gate reviews Interface with internal auditors and outside regulatory agencies\ auditors as the subject matter expert for new products and technology transfers

• Ph.D in Chemistry, Biochemistry, Chemical Engineering or related field Minimum 10 years experience in pharmaceutical or biotechnology industry
• Proven strategic leadership experience with the ability to inspire and motivate a diverse and global team.
• Extensive experience from working in an international organisation and across borders.
• Extensive and in-depth knowledge about clinical and commercial manufacturing, CMC process and analytical development.
• CMC technical lifecycle management In-depth understanding of regulatory and quality requirements in relevant area

Team Horizon