Nature and Scope
This position is responsible for site operations for an aseptic pharmaceutical manufacturing facility engaged in commercial manufacturing, aseptic filling, compounding, inspection, and packaging, along with critical support departments such as Validation, Maintenance, Engineering, Facilities and Security. The incumbent will be responsible for hiring and developing talent within a unionized environment and will develop and maintain succession plans for all direct reports. The incumbent will interface in an inter-disciplinary environment that will include, but not limited to; Quality, Research and Development, Technical Services, Finance, EHS, Supply Chain Associates, Human Resources and Corporate Administration at all ARI locations. This position will also serve as point of contact for all applicable audits.
Essential Duties and Responsibilities
Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
General:
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Manage manufacturing, production and support operations including aseptic filling, compounding, inspection, packaging, validation, maintenance, engineering, facilities and security.
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Manage the manufacturing investigation team and process engineers to support manufacturing/ production as necessary.
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Maintain all aspects of cGMP compliance for production areas of responsibility.
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Ensures that facilities, equipment and processes meet design specifications and remain in a constant state of compliance.
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Maintains a satisfactory level of housekeeping.
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Monitors safety and takes positive steps to eliminate hazardous situations.
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Evaluates employees’ job performance and attendance as required.
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Works with subordinates to further their personal skill and development.
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Responsible for training and professional development of the employees.
Management:
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Manage operation in an efficient and compliant manner.
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Reviews equipment availability and preparedness in conjunction with the schedule.
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Provides guidance, direction, and training for staff.
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Works with subordinates to further develop skills.
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Will hold routine staff meetings with direct reports as well as with indirect reports.
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As requested, develop, prepare and manage operational plans and budgets, including expense, capital and manpower, as well as preparing routine operational metrics as required by management.
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Will develop and maintain operating standards, hours and yield, for commercial products.
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Ensures both equipment and systems supporting Manufacturing, Quality and R&D remain in a state of repair and that any repairs made are handled and documented, as appropriate, through proper Change Control procedure.
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Incumbent will challenge and improve upon existing operating standards to include a proactive, continuous improvement on metrics associated with throughput and efficiency.
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Ensure that appropriate Standard Operating Procedures are in place and that all staff has been adequately trained to perform their assigned tasks in a cGMP compliant manner.
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Manage and lead all capital expenditures for designated facilities.
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Ensure a clean and safe work environment exists for all site personnel. This is to include working with Environmental, Health and Safety (EHS) to ensure that all operational personnel have received EHS training.
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As required, work with R&D, to ensure scheduling and the efficient turnover of all technical and process related knowledge and functionality occurs. Will also work with R&D to correct process issues as they arise.
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Along with Regulatory Affairs and Quality is responsible for implementing operational strategies, policies and procedures that ensure compliance to cGMP’s and the appropriate product licenses.
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Perform any other tasks/duties as assigned by management.
Education Requirements and Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.
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Bachelor’s Degree required. Engineering degree preferred.
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12+ years of progressive pharmaceutical experience and responsibility in parenteral manufacturing, filling and packaging operations.
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Minimum of ten (10) years of managing/supervising pharmaceutical manufacturing operations.
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Experience managing a Unionized environment as well as contract negotiations.
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Strong knowledge and expertise across multiple areas which may include, but not limited to, in-depth knowledge of cGMP’s, validation principles, engineering & maintenance principles, lyophilization technology, conventional and aseptic barrier systems, budgeting, master scheduling and production planning. Experience with cytotoxic compounds a plus.
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Knowledge of and experience, preferred, in the processing of complex molecules, biologics and recombinant DNA technology products.
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Proven record of exceptional people and program management skills.
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Excellent organizational, interpersonal and communication skills (oral and written).
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Demonstrated ability to build diverse teams, lead and motivate diverse groups of people to meet established goals.
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Ability to work off hours and weekends.
Expected Salary Range :
$250,000-$300,000
The salary range, displayed is the minimum and maximum annual salary range of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate’s qualifications, education, knowledge, skills and experience.
American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide range of other benefits.
American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.
American Regent Inc. endeavors to make
https://americanregent.com/Careers
accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email
hrtalentacquisition@americanregent.com
.