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What a Manager, Chem/Pharma Ops (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.
Travel is required 10%.
What is expected of you and others at this level
Manages professional employees and/or supervisors; may manage business support, technical or production staff. Applies expertise to improve effectiveness and provide guidance to employees in own area.
Ensures that continual training, growth, and development of team are adapted based on need.
Has accountability for managing financial resources. Manages budget for own area and allocates resources accordingly, applying knowledge of profit drivers within own area/job family.
Develops processes and procedures to implement functional strategies.
Makes decisions, often difficult and/or unpopular, that impact the work of subordinates within job family; influences subordinates to support decision by presenting rationale/business case.
Role models Cardinal Health's high ethical standards and code of conduct.
Recognizes development needs and capability gaps in own area and arranges specific projects/assignments to address needs.
Proactively identifies talent internally and externally, including participation in succession planning process for job family.
Cascades organizational goals to the individual level ensuring that individuals understand how they can contribute by establishing goals and achieving results within own job family, holding self and others accountable for results.
Builds confidence and respect of others through a positive and energizing style.
Interprets internal/external business issues and adapts work priorities in own area.
Works with customers to anticipate and interpret customer needs and business challenges by identifying quality and service-oriented customer solutions and shares key learnings with others.
Encourages subordinates to strive for operational excellence by continually challenging old methods or ways of thinking and taking responsible risks to maximize results; serves as a role model in innovative thinking and in focusing on quality within work.
Effectively solicits and explains difficult concepts and persuades others to adopt a point of view; states own point of view.
Responsible for being a culture champion by participating in the development, monitoring and sustainment of the culture that is an integral part of the Indy manufacturing site philosophy and vision. The incumbent is responsible for embracing and demonstrating the culture of energy, passion and positive atmosphere while delivering superb customer service.
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.
The ability to act calmly and patiently when working under pressure and/conditions of stress. Maintains integrity, composure, communicates with honesty, transparency, clarity and promotes alternative perspectives.
Required B.S. Chemical Engineering, Mechanical Engineering, Chemistry, or Business Management (with proven pharmaceutical manufacturing experience).
At least 7 -10 years of relevant work experience working with 21 CFR, parts 11, 210, 211 in the FDA regulated industry (Pharmaceutical or Medical Device).
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.
Have experience in batch record writing experience, SOPs, and deviation investigations.
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.
Physical/ Mental Requirements
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms; stoop, kneel, crouch or crawl; and talk or hear. The employee must occasionally lift or move up to 50 pounds. Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, depth perception and the ability to adjust focus.
The primary work environment consists of a professional office and production environment within a radiopharmaceutical manufacturing facility. 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 groups. 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.
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I enjoy playing an integral role in ensuring that our customers are receiving the right product in a timely and orderly fashion.
I also like the friendly atmosphere at our facility and I appreciate the balance between work and personal time that Cardinal Health gives its employees.
Mo, Senior Associate, Shipping Control Coordinator