Technical Manager (Biologics)
AbbVie Ballytivnan is a state-of-the-art Biologics aseptic fill finish facility.
We are looking for a Technical Manager to provide technical support and day-to-day program management to all new product introductions (NPIs) which will include biologics and ADCs. The position is based in Sligo and reports to the Technical Operations Manager. The successful candidate will provide team leadership to the NPI product team, process team, and ADC team. This is an exciting time to join the team as we continue to introduce new products and innovation.
Roles and Responsibilities
- 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 commercialisation.
- Complete all site fit assessments for all the products from AbbVie 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
- 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
- Masters in Chemistry, Biochemistry, Chemical Engineering, or related field
- 7+ years’ experience in a GMP biologics manufacturing environment.
- Experience of Technical Transfers/NPIs is essential.
- Proven leadership experience with the ability to inspire and motivate a diverse team.
- 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.
- ADC and/or Sterile fill finish experience an advantage but not essential
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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