Biologics Manufacturing Team Lead

Job title:

Biologics Manufacturing Team Lead

Company

AbbVie

Job description

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 DescriptionIf you want to be a difference maker our people are waiting. See the difference you can make at AbbVie.Working at AbbVie is more than a job. It’s a career with meaning. A chance to make a difference, in the world and in your life.We make sure you have everything you need to reach higher ground in your career. From growing and learning together to fostering a supportive space for you to thrive-at AbbVie and beyond.Join our dynamic team at AbbVie Ballytivnan (Sligo) and be part of groundbreaking work in Antibody Drug Conjugation (ADC) Drug Substance Manufacture and Fill/Finish.As a Team Lead in our Biologics division you will assure the long-term effectiveness of the team: deliver high levels of customer service, ensure quality of product and services, comply with all regulatory requirements, and build an inclusive culture of high performance for the team.You will be responsible for oversight of room and equipment qualification, developing SOPs for new manufacturing processes, collaborating with vendors for equipment procurement, and training of operations technicians and managing the team to hit scheduled milestone.Other responsibilities will include:

• Lead and manage the operations team, ensuring adherence to safety, regulatory, and operational requirements.
• Foster a high-performance culture focused on customer service, quality, compliance, financial performance, and inclusion.
• Oversee and execute ADC Drug Substance manufacturing activities (Buffer Preparation, Conjugation, UFDF & filling. and support processing activities.
• Prioritize safety and compliance in all activities, conducting regular safety Gembas and promoting a culture of zero safety incidents.
• Review daily work activities to identify and address high-risk activities.
• Ensure compliance with EHS standards, procedures, and policies.
• Promote a culture of contamination control and adherence to aseptic best practices.
• Effectively deploy and manage team members to meet production schedules.
• Provide daily reporting on the status of operations and support activities.
• Lead, motivate, and direct the manufacturing team to maximize effectiveness.
• Foster team engagement through regular one-on-ones, clear expectations, feedback, performance reviews, and action plans.
• Develop direct reports through training, challenging tasks, and performance reviews.
• Promote a culture of Right First Time execution, Behavioral Based Safety, Always Audit Ready, and Human Error Reduction.
• Drive operational excellence and achieve key operations targets, including OEE.
• Ensure compliance with safety, environmental, and quality-related SOPs.
• Collaborate with other Technical Shift Leaders for interdepartmental planning and execution.
• Schedule human and material resources to meet production schedules.
• Utilize management infrastructure tools, trackers, visual management, tier meetings, and Gemba walks.
• Ensure smooth shift handover and communication of performance metrics.
• Identify and supervise critical process steps during your shift.
• Achieve financial targets by improving overhead spend, material usage, and labor efficiency.
• Manage cycle time and identify improvement opportunities.
• Collaborate with program management, supply chain, technical operations, quality, and engineering for effective planning, scheduling, and execution.
• Provide technical guidance and approval for manufacturing batch records.
• Verify and update manufacturing control system transactions accurately and timely.
• Serve as the key technical contact for aseptic fill-finish activities.
• Support the documentation and investigation of NCRs.
• Interface with QA department for interactions with HPRA, FDA, and other health authorities.
• Lead cross-functional risk assessments and continuous improvement projects.
• Compile and analyze data to track process performance.
• Provide technical expertise for investigations, root cause analysis, CAPAs, process improvements, and change control reviews and approvals.
• Manage compliance issues that may arise during shifts and ensure adherence to regulatory requirements.

QualificationsEssential Qualifications:·Degree, Masters or PhD in Life Sciences, Process Engineering, Biopharmaceutical Engineering or Chemical Engineering discipline· At least five (5) years in pharmaceutical Operations, Technical Operations or process engineering, with relevant experience of batch processing – experience in an FDA/HPRA regulated industry.· ADC Manufacturing or Large molecule downstream purification (UFDF, Chromatography, Buffer Prep. etc.) desirable.· Detailed knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry is required for this role.· Comprehensive understanding of the principles of contamination control and regulatory expectations for aseptic processing.· Has a technical background in pharmaceutical, biologics, or similar industries· Experience of start-ups and/or new product introductions to bio-pharmaceutical/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 in a team environment· 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. ·Additional InformationYou’re here to make a difference. We have the science to turn you into difference makers.So, does this all sound like the right role for you? Then come join AbbVie!AbbVie is an Equal Employment Opportunity Employer; we value bringing together individuals from diverse backgrounds to develop innovative solutions for patients and being part of an inclusive work environment.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.US & Puerto Rico only – to learn more, visitUS & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

Expected salary

Location

Sligo

Job date

Fri, 25 Oct 2024 22:04:24 GMT

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