Allergan plc (NYSE: AGN) is a bold, global pharmaceutical company and a leader in a new industry model - Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.
Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.
Allergan is a company that will inspire you to aim high with your ambition. Where you can build bridges all over the world. Where you can power ideas that drive change. And where you will act fast and drive results for customers and patients. Power your future & join our bold team.
Responsible for safe, regulatory compliant operation of manufacturing in a designated area. Ensures production quantity and quality, by managing formulation/compounding, production, functional testing, maintenance, and coordinating engineering for the manufacture and shipping of products in compliance with cGMP's, SOPs, and the site goals and company objectives.
Main Areas of Responsibilities
This position is responsible for:
Manage manufacturing operations and monitor production and quality, to anticipate and solve problems in a timely manner, and to identify opportunities for improvement.
Initiate and manage projects that improve quality, efficiency and/or reduce operating costs.
Maintain adequate records, on a daily, weekly, or monthly basis, of key production variables such as production volume, product cost yield, plant uptime, utility consumption, etc.
Communicate with other departments (e.g., maintenance, validation, quality laboratories) to ensure of proper plant operation, quality and compliance.
Properly ensure inter-department communication to meet the planned schedules.
Manage all engineering studies, trials and validation batches in conjunction with Product Development ensuring all necessary requirements and protocols are in place to ensure timely and successful execution.
Serves as a member of site Leadership and participates in objective setting, strategic plan development, and performance review of plant.
Communicate regularly with all personnel, both individually and as a group, to ensure consistent operation of the facility.
Maintain and revise Standard Operating Procedures and ensures appropriate staff is trained.
Identifies and manages performance targets for direct reports.
Ensure all production and supporting equipment and utilities are properly maintained to support plant operation.
Perform other duties as assigned.
Incumbent has full authority to make decisions and/or take actions required to carry out job duties. Allergan internal requirements include compliance with ethics, environmental health and safety, financial, human resources, cGMP procedures, general business policies, requirements, and objectives. The incumbent must be willing to take temporary assignments as required.
The following listed requirements need to be met at a minimum level to be considered for the job:
Two (2) years of experience in supervision.
Ten (10) years' experience in manufacturing pharmaceutical or medical devices
Intermediate user knowledge and understanding of Windows based computer systems such as Microsoft Office and SAP, with an ability to learn other computer-based systems.
Green Belt certification or ability to become certified.
Proficient in Microsoft Word, Excel, and SAP.
Experience working in a GMP regulated environment preferred.
Experience working in an Aseptic Production environment preferred.
Highly developed interpersonal, written, and oral communication skills.
Must be able to effectively communicate and express ideas and concepts in written and oral form.
Highly developed leadership skills.
Computer literacy and proficiency in standard company applications.
Must interact appropriately and effectively with clients and with employees at all levels.
Communicates effectively with clients in a manner that generates confidence and builds trust.
Proficiency in a wide range of scientific research processes.
Comprehensive understanding of cGMP's, including experience in a cGMP environment.
Maintains currency and visibility in particular scientific discipline.
Effective Technical writing and reporting skills.
Knowledge of, and adherence to, all corporate safety regulations and OSHA standards.
Organizational skills sufficient to effectively plan, and lead new business efforts.
Familiar with each related group within the corporation and their capabilities.
Must work well independently and as part of a team.
The below skills are attributes that may not be mandatory but, are definitely, desired in the ideal candidate.
Ten (10) years of regulatory experience preferably in medical devices, pharmaceuticals, or related industry.
Experience in a cGMP manufacturing environment preferred.