Would you like to join an award winning organization that is dedicated to saving lives?
In 2019, Xellia Pharmaceuticals was recognized by the Business Culture Awards as an organization that has impacted its culture through transformative initiatives. Focused on building a sustainable environment through company values and a leadership promise to its employees. Our people make us what we are. We aim to attract the most talented, passionate employees in our industry and to earn their loyalty and commitment.
We support our employees through comprehensive people resources processes ensuring that every employee is treated fairly and has a voice which is listened to and valued.
Is that you? If so, we want to learn more about you!
Under the direction of the Sr. Manager, Sterile Operations, the Sterile Operations supervisor responsible for performing all necessary tasks both in and outside of the classified manufacturing suites in support of manufacture of safe and effective sterile (injectable) pharmaceutical products at the Xellia Cleveland plant. This position is primarily the direct supervision of manufacturing Aseptic Operators; ensuring sterile injectable pharmaceuticals are manufactured in strict adherence to cGMPs ensuring safety, quality, and potency of the product produced. Sterile Operations Supervisor is also the first level of management that ensures adherence to the production plan and delivery of On Time In Full targets.
- Ensure all aspects of floor operations are running in a smooth and efficient manner through proper planning of personnel, materials, and equipment availability in order to support continuous manufacturing operations
- Manage Aseptic Operators training plans making sure they are up to date, relevant, and applicable to their job function.Ensure of and understand regulatory requirements such as 21CFR part 210 and 211, cGMP's, FDA, OSHA and other regulatory agencies
- Ensure that current requirements to environment, safety and health issues are met with in their operational areas
- Engage all relevant stakeholder to facilitate systematic problem solving happens on the shop floor
- Responsible for personnel development and coaching discussions to include but not limited to annual performance reviews as well as performance plans
- Primary author in writing the departmental documents (SOPs, OJTs, Work Instructions, etc)
- May participate as in regulatory audits and tours as required, i.e. FDA, EMA, and others
Physical Requirements of the Role
- HS Diploma/GED and 6+ years applicable experience required
- Bachelors of Science and 0-5 yrs applicable experience preferred
- Advanced computer skills proficiency
- Military service highly desirable
- Demonstrated acuity to mechanical troubleshooting
- Position is exposed to plant environment
- This role is occasionally sitting and typing
- Occasionally requiring lifting and carrying less than 50 lbs.
- Standing, walking, bending over, and repetitive use of legs is done occasionally
- Candidate must be capable of physical movement with frequent bending and lifting up to 40lbs
- Candidate must be capable of extended periods of standing
- Candidate must physically be capable to successfully gown qualify
- Candidate will be required to wear PPE (Personal Protective Equipment), to include but not limited to respirator fit testing
- 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, shallbe worn as necessary to protect drug products from contamination
- Candidate will not be permitted to wear (in the classified manufacturing areas) jewelry, makeup, hair extension, or any exterior adornment (religious articles will be evaluated on a case by case basis as to assess impact on controlled environment and drug product)
- All personnel shallbe required to disclose any health conditions that may have an adverse effect on drug products
- Candidate will be required to work off shifts as required
- Candidate must have demonstrated ability to organize and lead medium size interdepartmental or cross functional teams
- Candidate must have demonstrated instances of advanced understanding and utilizing various business, quality and maintenance systems (i.e. Trackwise, MMS, LIMs, etc)
- Candidate must have demonstrated a high level understanding/execution of cGMP and GDPs, and is recognized as a compliance standard setter
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job. This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management. All requirements are subject to possible modification to reasonably accommodate individuals with a disability.
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
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