Biologics Manufacturing Pipeline: Manufacturing Supervisor

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 and LinkedIn.

Job Description

Thank you for considering a near future opportunity with our company! We are not currently hiring for this specific role at present, but we would love to connect with talented individuals who are interested in potential future positions. By joining our talent pipeline, you will be the first to be notified when suitable opportunities arise.

We are keen to connect with exceptional Biomanufacturing Supervisors, who are passionate about their work and excited to contribute to our continued growth, as we enter our next phase of expansion.

Purpose:

• Provides leadership and guidance to the stream specific Biologics group to manufacture clinical and bulk drug substance per safety, regulatory and operational requirements.

• Responsible for assuring that all performance metrics and workload deliverables are completed in alignment with the site’s business model

• Builds and maintains collaborative relationships with other team members within the site and departments

• Responsible for supporting Cell Culture, Purification or Central Services areas

• Performs general to complex duties in assigned area within the Biologics Production facility

• Complies with safety requirements, current Good Manufacturing Practices, and Standard Operating Procedures

• Organizes daily and weekly shift activities and directs shift personnel in execution of daily and weekly tasks

Major Responsibilities:

Operational and Technical

• Coordinates stream and cross-stream initiatives to achieve department objectives

• Provides expertise in stream-specific manufacturing related topics and audits

• Drives process troubleshooting effort for issues, proactively anticipates issues

• Assists with the implementation of changes and CAPAs

• Resolves project hurdles by effectively utilizing available information and technical expertise

• Initiates or implement changes relevant to manufacturing process

• Operation of Computerised Systems (e.g. Manufacturing Enterprise Systems (MES), Human

• Machine Interface (HMI)/ Programmable Logic Controller (PLC), etc.)

• Demonstrates ownership of stream-specific operation area, with basic understanding of operations and constraints of all streams:

  • Upstream: Inoculation, Cell Culture and Recovery
  • Downstream: Chromatography, Filtration, Ultrafiltration, Final Filling
  • Central Service: Buffer/ Media Preparation, Autoclave, Glasswash and cleaning processes, sampling of raw materials.

Safety

• Ensures safe work environment in accordance with regulatory and global/local EHS policies

• Reinforces importance of safety during critical operations and ensures that Positive Interventions and recommendations are regularly highlighted and acted upon.

Quality

• Oversees the creation or revision of batch records or standard operating procedures and associated training material.

• Responsible for supervision of manufacturing of bulk drug substance within the scope of safety and compliance/ cGMP manner

• Drives performance to ensure execution is carried out flawlessly to ensure Human Error related events are prevented in the shift team

• Provides inputs for investigation – impact assessment and appropriate CAPA

• Responsible for overall plant upkeep during the shift and ensuring plant is always audit-ready

• Reviews records for completeness and accuracy

• Point of contact for audit

Schedule

• Oversees deliverables ahead, anticipates complexities and prevents potential plant disruption

• Ensures processes are running as per planned schedule with minimal delays.

People and Culture

• Recruits, retains, manages performance and develops manufacturing personnel

• Sets a positive team environment and amplifies the AbbVie Ways We Work behaviors

Qualifications

• Bachelors / Masters in Sciences (i.e. Biologicals, Biomedical, Chemistry, Life Sciences, Pharmaceutical), Pharmacy, or Engineering (i.e. Biomedical, Chemical, Pharmaceutical), or equivalent

• Min. 5+ years of relevant work experience in Biotechnology/Pharmaceutical industry is required

• Min. 2 years of Supervisory Experience in Biotechnology / Pharmaceutical manufacturing area

• Working knowledge of safety, quality systems, and cGMPs is required

• Strong problem solving and prioritization skills are required

• Knowledge of complex technical issues and manufacturing experience in a biopharmaceutical / pharmaceutical or similar environment

• Strong workload management and organizational skills. Must be able to work with minimal management direction.

• Computer proficiency and scheduling experience required; good writing skills

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.

Multiple times, we have been globally recognized as a "Great Place to Work" and we are proud to provide our employees with the flexibility to maintain a healthy work-life balance. We take our impact on the environment and our communities seriously and therefore focus on giving something back on a regular basis. We are committed to equality, equity, diversity and inclusion (EED&I) – a commitment that is fundamental to us. This includes appreciating different perspectives, creating an inclusive culture and treating all employees with dignity and respect.

At AbbVie, your individual contributions count – help us move mountains together. Be a part of our success, grow with us and accomplish more than you could have imagined. Sounds like the perfect career opportunity for you? We look forward to receiving your interest! All you need is a complete CV – we will discuss everything else with you.

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

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https://www.abbvie.com/join-us/reasonable-accommodations.html