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, LinkedIn and Tik Tok.
Job Description
Purpose:
- Responsible for providing leadership, support, management, guidance and supervision for the API operations team to ensure that all day-to-day activities of operations run smoothly and seamlessly.
- Responsible for ensuring 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.
Major Responsibilities:
Operational and Technical
- Responsible for the supervision of API manufacturing and overall plant operations during the 12-hour working shift.
- Manage human-error related non-conformance as required, ensuring appropriate communication within the team and with cross-functional teams. Provide input to investigations.
- Resolve complex technical issues surrounding on-going processes and process equipment during the 12-hour working shift.
- Closely monitors the process of critical steps and ensures flawless execution
- Authors or revises standard operating procedures and JSTM
- Host Tier 2 meetings and escalate any production related matters to other cross-functions in a timely manner.
- Drive operational and process related improvements to achieve site business targets and manufacturing excellence.
- Performs daily GEMBA walks with Manufacturing Manager/Lead/Supervisor to identify operational gaps or areas for improvements
- Assists Manufacturing Manager/Lead in planning and leading area activities.
- Assume the role of deputy in the absence of Manufacturing Manager/Lead
- Represent functional area during cross functional meeting where assigned by manager
Safety
- Assumes the role of lead of the Emergency Response Team and Site Incident Commander when on shift.
- Builds and promotes strong safety culture and oversees that ensures Positive Interventions and recommendations are regularly highlighted and acted upon.
- Maintain a safe work environment in accordance with regulatory and global/local EHS policies
- 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
- Provide inputs for investigation – impact assessment and appropriate CAPA
- Responsible for overall plant upkeep during the shift and ensuring plant is always in audit ready mode
Schedule
- Oversees deliverables ahead, anticipates complexities and prevents potential
- Ensures processes are running as per planned schedule with minimal delays. Highlights effectively to shift supervisor if delays are expected.
People and Culture
- Identify and develop talents; manage performance and oversees the overall development direct reports
- Involved the recruitment of Pharmatechnologists in the team
- Sets a positive team environment and amplifies the AbbVie Ways We Work behaviors and driving culture and engagement
- Coaches and trains Pharmatechnologists as a qualified / certified trainer
Qualifications
- Degree in Chemical Engineering/Chemistry or equivalent technical related degree is required
- At least 10 years of experience in working in a GMP manufacturing environment required
- At least 2 years of people management experience is preferred
- Able to work comfortably in 12-hour rotating shift (Day/Night)
- Leadership experience in training less experienced chemical technicians 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
