ADC Technical Manager

Sligo
Permanent
Full-time

16 days ago

Company DescriptionAbbVie'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 . Follow @abbvie on , , , , and .Job DescriptionAbbVie 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 an ADC 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 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 new
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

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.

Additional InformationAbbVie 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, visitUS & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

AbbVie

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