Technical Manager (Biologics) at AbbVie in Sligo, Connacht, Ireland

companyDescription
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
jobDescription
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
qualifications
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
additionalInformation
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.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html