Lead Biotechnologist (Central Services)

Performs functions associated with cGMP manufacturing operations within the biologics production facility, including working with engineers in set-up and calibration tasks, as well as performing rework and quality testing related to the production of parts, components, and final materials.

Responsibilities

• Completes batch documentation accurately and thoroughly, while adhering to the required quality and safety standards, and in a productive, cost-effective manner.
• Supports and leads operations & troubleshooting efforts during course of shift work to ensure adherence to schedule and production plan.
• Stands in as Deputy for Manufacturing Supervisor in his/her absence.
• Operations and Technical Demonstrates ownership of central services stream-specific operation area including Buffer/ Media Preparation, Autoclave, Glasswash and cleaning processes, sampling of raw materials.
• Plans and executes manufacturing operations using validated programs (such as LIMS, SAP, DeltaV, POMSnet, automated control systems, etc.) Completes manufacturing tasks efficiently
• Demonstrates high degree of initiative to resolve issues

Makes recommendations for and implements new procedures

• Acts independently to determine methods and procedures on new assignments
• Drives projects and innovations to streamline processes and operation steps

Drives the resolution of anomalous processing events timely

• Initiates Demand Work Order Safety Ensured safe work environment in accordance with regulatory and global/local EHS policies
• Reinforces importance of safety during critical operations and ensure that Positive Interventions and recommendations are regularly highlighted and acted upon.
• Leads safety risks assessments or participates in process hazard analysis as an operations representative (PHA) Quality Responsible for the completeness and accuracy of all records
• Ensures that all batch related document errors are resolved in a timely manner to avoid batch review and release delays
• Communicates all events/issues effectively with relevant stakeholders
• Drive performance to ensure execution is carried out flawlessly to ensure

Human Error related events are prevented

• Responsible for overall plant upkeep during the shift and ensuring plant is always in audit ready mode
• Is involved in preparation for regulatory audits and inspections
• Initiates Quality Records (Non-conformance) Schedule Assists supervisor in planning to ensure adequate resources are available to support manufacturing demands per production schedule.
• Assigns tasks within the shift team to biotechnologists
• Provides inputs to supervisor and manufacturing planner in events of unplanned downtimes
• Represents the shift in cross-functional meetings
• People and Culture Sets a positive team environment and exemplifies the AbbVie Ways We Work behaviors
• Coaches and trains other biotechnologists (100% trainer competency)

Assists in developing training materials

• 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 US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html
• About AbbVie 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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.

Requirements

• Bachelors 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 Biologics / Pharmaceutical industry required.
• Experience should include 3+ years of area/central services stream specific experience, including Buffer/ Media Preparation, Autoclave, Glasswash and cleaning processes, sampling of raw materials.

Experience leading a shift team required

• Highly skilled specialist and strong problem solver who independently tackles complex assignments with initiative, contributing to the development of innovative concepts and techniques
• Demonstrated ability to multi-task and work in a fast-paced environment, takes full ownership of tasks assigned and acts with personal integrity
• Knowledge of complex technical issues and manufacturing experience in a biopharmaceutical / pharmaceutical or similar environment
• Good interpersonal and communication skills required
• Excellent team player, with experience in shift work required