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About
Find out exactly what skills, experience, and qualifications you will need to succeed in this role before applying below.
Why you should apply:
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.
What you will be doing:
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
provide technical input, review\ approval for documentation associated with NPI activities
Ensure ongoing compliance with CGMP and EHS practices new
Participate in NPI project gate reviewsInterface with internal auditors and outside regulatory agencies\ auditors as the subject matter expert for new products and technology transfers
What you need to apply:
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. xcfaprz
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
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Languages
- English
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