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.
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Job Description
We have an exciting new opportunity for an NPI Product Lead to join our Technical Operations team in Sligo. This position reports to the NPI Technical Manager. The successful candidate will provide technical support and day-to-day program management to all NPI across the site.
Roles and Responsibilities
Lead and support New Product Introduction activities for product, processes, and technologies from early-stage development through PPQ.Provide technical direction, oversight, and coordinate support for NPI activities within biological manufacturing area.Work closely with internal and external program management to ensure alignment on NPI schedules.Resource planning to ensure the required personnel are available to support manufacturing operations during NPI executions and ensure operations run safely and efficiently.Provide direct interface as a subject matter expert with QA department, HPRA, FDA and applicable health authority and internal audits.Drive innovation and continuous improvement.Provide leadership and mentoring for operations personnel during NPI activities.Collaborate closely with external partners to ensure engagement, alignment, and open communication during NPI activities.Collaborate with external and internal partners to influence the design and implementation.of robust process control strategies and process risk assessments.Generation of product transfer documentation to attest the completion of product transfer deliverables in advance of the applicable product transfer stage gate review.Ensure ongoing compliance with cGMP and EH&S 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.Provide technical input, review/approval for documentation associated with NPI activities.Qualifications
Bachelor’s degree in engineering, science or closely related subject area.5+ years experience in Pharmaceutical or Bio Industries with a minimum of 2 years experience in a similar role.Strong technical and operational knowledge of unit operation within an aseptic fill finish facility.Career history marked by a consistent series of technical contributions and accomplishments. Recognition given to significant contribution to product or process development or improvement through creative application of technical effort.Excellent critical thinking skills and the ability to influence cross-functional teams are essential.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
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