NPI Product Lead
NPI Product Lead
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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 daytoday program management to all NPI across the site.
Roles and Responsibilities
- Lead and support New Product Introduction activities for product processes and technologies from earlystage 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 :
- Bachelors 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 crossfunctional 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 AbbVies 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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Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
