Manager, Nuclear Manufacturing (Pharmaceutical Production)

What Nuclear Manufacturing contributes to Cardinal Health

Nuclear Manufacturing is responsible for the manufacturing of time sensitive radiopharmaceuticals in an integrity driven, highly regulated environment (i.e. FDA, NRC, DOT) to support patient treatment through disease diagnosis, staging, and monitoring.

What a Manager, Nuclear Manufacturing (Production) contributes to Cardinal Health

  • Reports to Sr. Director, Operations.
  • The manager will lead, organize, and manage personnel and activities in all manufacturing activities under cGMP regulations, to serve as the primary contact for manufacturing related communications, and to provide guidance to the manufacturing team to ensure consistent execution and improvement of the manufacturing process.
  • The Manufacturing Manager creates an environment where teamwork, productivity, safety, identity, strength, purity and quality (SISPQ) are reflected in the finished product.
  • Performs and leads 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) and maintains records as required. May monitor and verify quality in accordance with statistical process or other control procedures.
  • Effectively manage tasks associated with daily manufacturing activities and CAPA implementation.  Investigate deviations arising during the manufacturing processes and recommend appropriate CAPA, and ensure effectiveness of the action items associated with those CAPAs.
  • Foster a collaborative working environment within the various departments within Cardinal Health.  This includes ensuring that communication is maintained between department managers and giving support to other departments when needed.

Accountabilities

  • Takes personal responsibility to develop, deploy, and properly manage a culture of safety and working conditions.  Adheres to all environmental, health, and safety SOPs and policies.  Actions and decisions must reflect that our team member’s safety is always first on our minds.
  • Leads in such a manner that inspires the trust of his / her subordinates, peers, and superiors.  Must lead as a role model of respect and integrity.
  • Interviews, hires, coaches, and develops staff. Provides timely and accurate feedback recognizing good / poor performance.  Establishes clear direction and priorities for the manufacturing team, and empowers team members to obtain results that support strategic objectives.
  • Leads / partners with quality and technical services leaders to either author, review and / or approve deviations and drive timely closure to meet client delivery dates.
  • Approves SOP’s, validations, and protocols relating to production operations and ensures their implementation in a timely manner.
  • Partners with department leaders to manage client projects and host client audits. 
  • Provide technical expertise and resources, cooperating and coordinating with Quality, Engineering, Maintenance and Technical Services.
  • Interfaces with the other department’s operations management staff/customers to ensure our quality commitments are met.
  • Participates in the development of policies and procedures to achieve specific goals.
  • Ensures employees operate within guidelines using appropriate employee relations protocol when necessary.
  • Ensures that products are produced and stored according to the appropriate documentation in order to obtain the required quality.
  • Ensures that production records are evaluated and signed by an authorized person.
  • Partners with the Engineering Department and Validations Team to ensure the qualification and maintenance of the Production Department, premises, and equipment and that validations are completed.
  • Responsible for the overall monitoring and control of cleanliness and hygiene of the manufacturing environment.
  • Performs other job duties as assigned.
  • Models the characteristics outlined in the Cardinal Health Leadership Essentials-  Managers of People,
  • Process, or Projects.

  • Demonstrates a commitment to the organization’s mission, vision and values supporting organizational decisions and behaviors. Contributes to the development and implementation of systems and processes ensuring strategic goal attainment.
  • Works as part of a team with others and shows respect and values diversity toward others.
  • Demonstrates efforts to discovering, meeting and advocating for the customer’s needs.
  • Takes actions to continually improve quality and safety in daily work. Actively participates in improving work processes to meet and exceed expectations. Identifies opportunities for improvement based on process observations, outcome measures, and feedback.
  • Reports errors in a timely and appropriate manner. Takes initiative and is accountable for areas of responsibility meeting regulatory requirements including but not limited to maintaining required trainings as appropriate to position requirements.
  • Acts calmly and patiently when working under pressure and/conditions of stress. Maintains integrity, composure, communicates with honesty, transparency, clarity and promotes alternative perspectives.

Qualifications

  • Bachelors degree or equivalent experience in related field required. Chemical Engineering, Mechanical Engineering, Chemistry, or Business Management (with proven pharmaceutical manufacturing experience) strongly preferred
  • A minimum of 4+ years related work experience required, including 1+ year supervisory experience. Preferred: 7 -10 years of relevant work experience working with 21 CFR, parts 11, 210, 211 in the FDA regulated industry (Pharmaceutical or Medical Device).   
  • 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
  • Must work well with others and understand how to be successful in a Team environment. 
  • Must be detail oriented, organized, able to multi-task, a self-starter, and self-motivated.
  • Experience in batch record writing experience, SOPs, and deviation investigations strongly preferred.
  • Must be proficient in Microsoft Word and Microsoft Excel and possess strong technical writing skills.  
  • Demonstrated success in managing people and leading a team.
  • Strong communication skills.
  • Up to 10% travel

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 a short term 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 involves resolution of issues related to operations and/or projects
  • Gains consensus from various parties involved

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.