Sterile Operations Manager

Xellia Pharmaceuticals - Cleveland, OH3.6

Full-timeEstimated: $97,000 - $130,000 a year
EducationSkills
Production

Position Summary

This role will manage all unit operations (Components Preparation, Compounding, Filling, Lyophilization, Capping, Operations Support, and Production Maintenance). This manager will ensure manufacturing operations are executed in CGMP complaint manner and comply with all applicable regulations. This role will establish systems that support that procedures are continuously improved to heighten quality. Ensure adherence to the production plan and delivery of on time and in full targets by having stable processes with minimal variation. Develop direct reports competences and skills, manage, lead and motivate the sterile operations team in an empathetic and trusting manner.

Key Responsibilities

Ensure daily production is running optimally, both in terms of output and quality.
Proactively and continuously manage product risk and escalate risks through site management and the global organization as necessary.
Implement and conceive operational strategy to optimize process, production and maintenance systems for continuous performance improvement in safety, quality, cost, and schedule adherence.
Ensure that systematic problem solving happens on the shop floor where all relevant stakeholders are involved.
Share knowledge with other Xellia sites to ensure consistency of approach and sharing of best practices.
Develop, manage and control spending for the department. Support LTP Budget through scenario development and capacity utilization studies.
Have clearly defined roles and responsibility, so tasks, responsibilities and decision competencies are well understood by all department members.
Be present on shop floor to conduct coaching of leaders and exchange process knowledge.
Ensure all supervised personnel are adequately trained and perform routine inspections.
Do daily process confirmation of team leader tasks to ensure correct use of performance boards, systematic problem solving, and process confirmation of procedures related to operators, mechanics and others.
Ensure that all KPIs are visible, understandable and relevant for team and team leaders, and that the individual team member is aware of how to affect relevant KPIs.
Attract, retain and develop staff with the appropriate behaviours and commitment.
Conduct PMP, interviews, VoW and other activities according to the Xellia standard.
Work closely together with quality to solve quality issues as they occur and ensure timely release of products.
Ensure quick implementation of effective containments and countermeasures.
Provide Standard Operating Procedures and Work Instructions that are both comprehendible and simple to follow.
Ensure a fast and thorough follow-up on complaints and inspections.
Communicate challenges and successes honestly to all employees in the department and rest of organization.
Keep communication within and outside of department constructive.
Actively engage stakeholders, as stakeholder management is a critical component to succeeding.
Ensure that the work environment in the department lives up to the standing requirements.
Abide by the rules and regulations regarding environmental requirements.
Ensure processes and products are in compliance with all local, state, and federal rules and regulations. Oversee that processes are in CGMP compliance, and establish systems that identifies opportunities for improvement and makes constructive suggestions for change to improve process effectiveness to heighten quality. Develop knowledge of and understand regulatory requirements such as 21CFR Parts 210 and 211, cGMP’s, FDA, OSHA and other regulatory agencies.

Personnel engaged in the manufacture, processing, packing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform. Protective apparel, such as head, face, hand, and arm coverings, shall be worn as necessary to protect drug products from contamination.

Other duties as assigned.

Requirements

Bachelor’s degree required.
Master’s degree in Engineering, Natural Science or other relevant education is preferred.
10 years of experience in aseptic pharmaceutical production and a minimum of 5 years of experience in a managerial role leading teams required.
Prior experience must include managing production, including filling and lyophilisation experience.
Proven experience delegating, training, communicating and coaching teams. Also evaluating and disciplining others.
Capable of developing, creating, and implementing new practices, policies, and procedures.

Physical Requirements of the Role

Position is exposed to plant environment. This role is continuously sitting and typing. Frequently talking and using eye and hand coordination. Occasionally requiring lifting and carrying less than 10 lbs. Standing, walking, bending over, and repetitive use of legs are done occasionally. Any person shown at any time (either by medical examination or supervisory observation) to have an apparent illness or open lesions that may adversely affect the safety or quality of drug products shall be excluded from direct contact with components, drug product containers, closures, in-process materials, and drug products until the condition is corrected or determined by competent medical personnel not to jeopardize the safety or quality of drug products. All personnel shall be instructed to report to supervisory personnel any health conditions that may have an adverse effect on drug products.

Xellia Pharmaceuticals is owned by Novo Holding A/S and is a specialty pharmaceutical company leading in the development, manufacture and supply of anti-infective treatments. Headquartered in Copenhagen, Denmark, Xellia has global facilities in Europe, North America, and Asia, currently employing over 1700 people. With over 100 years of industry experience in developing last resort treatments for infectious diseases, Xellia is focused on the supply of products which not only save lives, but also improve and enhance patients’ quality of life. Together with us, you can help lead the fight against bacterial infections.
Read more about Xellia Pharmaceuticals here