*AbbVie Manufacturing Team Lead (Biologics)

Abbvie (Sligo, Ireland) 3 hours ago
About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at [...] Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Making a Global Impact?



Developing a Thriving Career?



At AbbVie We Offer That.



The complexities of our global organization provide unique opportunities for growth, job stability, and the pursuit of what matters most to us in our lives. Our passion for operational excellence helps us have a remarkable impact on lives around the world while maintaining a strong work/life balance that keeps us focused and fulfilled.



At AbbVie Ballytivnan in Sligo, we have developed an advanced Biologics Manufacturing facility that will bring groundbreaking scientific research to real-life solutions for our patients.



As part of our start-up phase, we are currently sourcing a Manufacturing Team Lead to join our highly skilled biologics fill-finish technician group. As our Manufacturing Team Lead, you will guide and support your new team across filling, lyophilization, equipment preparation, formulation, buffer preparation and processing activities in the biologics fill-finish facility to meet clearly stated operating objectives.



So are you ready to join AbbVie as our new Manufacturing Team Lead? Then read on…



Responsibilities:




  • Lead, motivate and develop the manufacturing team and provides technical expertise for investigation and resolution of process deviations, root cause investigation, CAPAs, process improvements, review, and approval of change controls

  • Promote a culture of contamination control and compliance with aseptic best practice

  • Provide daily reporting on the status of all operations and support activities

  • Take responsibility for verification and updating of manufacturing control system transactions accurately and in a timely fashion

  • Act as a key point of technical contact for aseptic fill-finish activities including communicating departmental goals to biologics technicians and providing cost-effective quality compliant products in a safe, effective manner

  • Liaise with program management, supply chain, technical operations quality and engineering groups to ensure effective planning, scheduling and execution of commercial and NPI clinical manufacturing

  • Resolves operations/project issues by working with team members, project customers, and others as appropriate

  • Promote operations excellences culture and Key operations targets including OEE where applicable

  • Provides direct interface as a subject matter expert with QA department to interaction with HPRA, FDA and applicable health authority and internal audits

  • Ensure the execution of fill-finish, lyophilization, equipment preparation, buffer preparation and formulation processing activities to meet clearly stated operating objectives

  • Successfully review, amend, and implement changes to SOPs

  • Promote a culture of Right First Time, Behavioral Based Safety, Always Audit Ready and Human Error Reduction within their team

  • Develop direct reports by securing appropriate training, assigning progressively challenging tasks, and managing mid-year and annual reviews

  • Schedules human and material resources within a department or section in conjunction with near-term plans to ensure their availability; carries out operations within an established budget

  • Provides required technical guidance and approval for manufacturing batch record

  • Compiles data from manufacturing, performing statistical analysis to trend and track process performance

  • Comply with the EHS policy and procedures and demonstrate EHS best practices in all work activities

Qualifications

Education and Technical Requirements:




  • Degree qualified (masters/PHD preferred) in Process, Biopharmaceutical, Chemical Engineering, or other relevant discipline required

  • A minimum of 5 years’ experience in batch processing, automation, commissioning, and validation in an FDA/HPRA regulated industry

  • Detailed knowledge of cGMP and regulatory requirements relating to the biopharmaceutical industry is required for this role

  • Comprehensive understanding of the principles of contamination control and regulatory expectations for aseptic processing

  • Technical knowledge of Biologics/Aseptic Fill-Finish manufacturing process

  • Experience of start-ups and/or new product introductions to biopharmaceutical/pharmaceutical facilities (Biologics Preferred). Must be able to lead & project manage these activities

  • Demonstrated project management skills, including the ability to deliver projects on schedule, within budget, and meeting the predefined quality and safety requirements.

  • A minimum of 1-year team direct supervisory experience essential

  • Possesses a strong technical knowledge and application of concepts, practices, and procedures. Works on problems of complex scope where analysis of situations or data involves multiple competing factors. Exercises judgment and advises management as to the appropriate actions.


Equal Employment Opportunity Employer:



At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer, we do not discriminate based on race, colour, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.


Travel
Yes, 5 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.

*AbbVie Manufacturing Team Lead (Biologics)

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