Manager, Chemical/ Pharmaceutical Operations (PET)
Cardinal Health PET Manufacturing Services is responsible for manufacturing PET (Positron Emission Tomography) isotopes to enhance patient treatment through improved disease diagnosis, staging, and monitoring.
Leveraging our fully integrated network of domestic nuclear pharmacies, Cardinal Health PET Manufacturing Services compounds, dispenses and distributes patient-specific, unit-dose PET products in pharmacy markets today.
What Chemical/ Pharmaceutical Ops contributes to Cardinal Health
Operates automatic and manual manufacturing and chemical process equipment of varying complexity in various production processes in accordance with operating procedures. Performs a variety of tasks related to the processing of ingredients and/or pharmaceutical products. Handles raw materials and intermediate or finished products. Performs standard operating procedures to meet current good manufacturing practices (GMP). Maintains records as required. May monitor and verify quality in accordance with statistical process or other control procedures.
What is expected of you and others at this level
- Manages department operations and supervises professional employees, frontline supervisors and/or business support staff
- Participates in the development of policies and procedures to achieve specific goals
- Ensures employees operate within guidelines
- Decisions have an immediate impact on work processes, outcomes, and customers
- Interacts with subordinates, peer customers and suppliers at various management levels. May interact with senior management
- Interactions normally involve resolution of issues related to operations and/or projects
- Gains consensus from various parties involved
- Oversees and directs designated PET Sites in the production of radiopharmaceuticals in accordance to quality and regulatory policies, operating procedures and company policies. Responsible for complying with the Quality Management System (QMS), including the following programs: CAPA, Change Control, Investigations, Complaints and Annual Product Reviews.
- Directs and co-ordinates the activities of subordinate Management through the development of valid performance plans to ensure timely manufacture and packaging of products consistent with objectives. Establish performance goals, development plans, and monitor results. Develops, trains, and motivates employees including supervisory team members to maximize job performance. Interviews, hires, disciplines, recommends termination, and evaluates all employees under his/her direct supervision.
- Oversees and ensures area policies are consistent with company policies and philosophy. Manages the application and administration of such policies in conformity with cGMPs.
- Establishes and maintains safety environments and processes in compliance with regulatory, radiation safety procedures, EHS, cGMP and company policies. Conducts and participates in safety programs with subordinates. Maintains an effective audit program to assure safe and sanitary conditions throughout the facility.
- Responsible to ensure Management provides employee training and that requirements are successfully completed and training documentation is current. Provides direction for teambuilding and employee motivation and development. Applies knowledge and skills to effectively enhance the smooth functioning and productivity of the team.
- Recommend changes to Technical Operations group that will improve performance, quality of product or services, and increase efficiency.
- Ensures that the sites have all the components and raw materials in stock and maintain the inventory management system through computerized systems.
- Oversees routine internal audits of quality management systems. Ensures that investigation on deviations and OOS from both operations and QC laboratory are conducted in a timely and complete fashion. Works on a mechanism for reducing the trend of such to manageable and negligible levels.
- Oversees site Management to ensure production capability of the facility and makes recommendations accordingly for service and repair of critical components including the cyclotron, chemistry systems, analytical equipment, and environmental controls (facility systems).
- Ensures production efficiency by securing the transfer of the proper amount of produced material to the pharmacies. Provides customer satisfaction and addresses customer concerns accordingly, including internal and external stakeholders.
- Develops and implements annual budget and ensures attainment of budget objectives. Evaluates monthly progress on business performance. Responsibility and accountability for P&L.
- Direct the overall integration of newly acquired sites and build out of new sites.
- Perform other assignments/duties as required or directed to ensure the business objectives are met. Implement special project work as required and build applicable teams to meet project goals.
- Models the Leadership Essentials to create a culture that brings out the best in all…driving higher levels of performance and creating a competitive advantage. Refer to the Leadership Essentials that apply to this role – “Managers of People, Processes, or Projects”.
- Location: Manage facilities in Hartford, CT and Woburn, MA - candidate must live within these areas
- Facility hours: 9pm - 11am (8 hour shift). Must be flexible as this is subject to change
- Bachelors degree or equivalent experience in related field required
- Minimum of 5 years experience of cGMP in the pharmaceutical or medical device industry
- 3+ years of supervisory experience
- Demonstrated success in managing people and leading multiples teams and/or departments.
- Strong communication skills.
- Demonstrated success in achieving results along with strong financial acumen and project management.
- Ability to see fine particulate and differentiate colors.
- Ability to hear, write, and speak clearly in order to communicate with customers and health care professionals.
- Manual dexterity required for occasional reach and lifting of small objects.
- Demonstrated manual dexterity in order to draw doses and manipulate remote arms and Quality Control equipment.
- Ability to lift containers weighing up to 50 lbs.
- Travel when required to meet business needs.
Site- based position. The primary work environment consists of a cyclotron and associated manufacturing facility for the production of PET radiopharmaceuticals, which must be kept clean, orderly, properly lighted and maintained in optimum operating condition. Employees handle radioactive materials and are exposed to very low amounts of radiation that are deemed safe by current standards. The facility is operated under well-controlled and closely monitored conditions that are regulated by both State and Federal agencies, and that are enforced by the corporate internal quality and regulatory group. Each staff member will receive specific training in keeping radiation exposures within regulatory guidelines and he/she will be routinely monitored for their exposure to radiation. Noise levels are considered low to moderate.
Cardinal Health is an Equal Opportunity/Affirmative Action employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex,
sexual orientation, gender identity, national origin, disability, or protected veteran status.