Lead Biotechnologist (Upstream)

Company Description

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.

Job Description

Purpose:

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.

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.

Major Responsibilities:

Operations and Technical

Demonstrates ownership of upstream-specific operation area, including Inoculation, Cell Culture and Recovery

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

Qualifications

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 / upstream specific experience, including Inoculation, Cell Culture and Recovery

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

Additional Information

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