Senior, Expert
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
AbbVie 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
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Lead and support NPI activities for product, processes and technology from early-stage development through to PPQ.
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Lead and manage cross functional teams across different skillsets and disciplines to perform activities required to deliver NPI's.
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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.
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Complete all site fit assessments for all the products from AbbVie pipeline and ECM opportunities
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Provide technical direction and oversight and coordinate support for NPI activities across the entire biological manufacturing area
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Work closely with internal and external program management to ensure alignment on NPI schedules
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Ensure resource availability for all NPI related activities
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Build and maintain a mindset of innovation and continuous improvement withing the function.
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Provide leadership and mentoring for operations personnel during NPI activities
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Collaborate with external parties to ensure engagement and alignment and open communication throughout NPI activities
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Engage with external and internal partners to influence the design and implementation of robust process control strategies on process risk assessments
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Generate product transfer documentation to attest the completion of product transfer deliverables in advance of the application product transfer stage gate review
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provide technical input, review\ approval for documentation associated with NPI activities
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Ensure ongoing compliance with CGMP and EHS practices
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Participate in NPI project gate reviews
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Interface with internal auditors and outside regulatory agencies\ auditors as the subject matter expert for new products and technology transfers
Qualifications
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Masters in Chemistry, Biochemistry, Chemical Engineering or related field
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Minimum 10 years experience in pharmaceutical or biotechnology industry
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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.
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Extensive and in-depth knowledge about clinical and commercial manufacturing, CMC process and analytical development. CMC technical lifecycle management
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In-depth understanding of regulatory and quality requirements in relevant area.
Additional Information
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
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