Technical Manager (Biologics)

Company Description:

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.

Job Description:

Abb Vie Ballytivnan is a Centre of Excellence for Precision High Volume Moulding and Auto-Assembly, and 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) sitewide across 3 departments which will include ADC conjugation, BT1 and ADCBT2. The position is based in** Sligo** and report 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 commercialization.
• Complete all site fit assessments for all the products from Abb Vie 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
• 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.

Additional Information:

Abb Vie 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