Supervisor, Manufacturing-Bulk-Nights at Alkermes, Inc. in Wilmington, Ohio

Posted in Other 9 days ago.





Job Description:

Manufacturing Supervisor-Bulk-Nights (6PM-6AM)


Company Overview:


Alkermes plcis a fully integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology. The company has a portfolio of proprietary commercial products focused on addiction and schizophrenia, and a pipeline of product candidates in development for schizophrenia, bipolar I disorder, neurodegenerative disorders and cancer. Headquartered inDublin, Ireland,Alkermes plchas an R&D center inWaltham, Massachusetts; a research and manufacturing facility in Athlone,Ireland; and a manufacturing facility inWilmington, Ohio. For more information, please visit Alkermes'website atwww.alkermes.com.


GENERAL DESCRIPTION:


This position will provide direct leadership on the assigned shift in the manufacture of commercial product. Manages multi-disciplined teams in a pharmaceutical production area to ensure all manufacturing systems, production processes, equipment and final pharmaceutical product meets or exceeds Alkermes manufacturing standards, regulatory requirements and business objectives.


KEY DUTIES:




  • Acts functionally as the operational leader on the floor during the assigned shift with direct responsibility for Manufacturing Associates and operations executed by that shift




  • Provides effective, 'hands-on' leadership to the production team as a whole




  • Accountable for "in the room" operations and personnel for their assigned shift (safety, reliability, operability)




  • Plans and supervises daily execution of tasks to support published production plan and supervises completion of work




  • Communicates plan and leads shift effectively




  • Supports the Manufacturing Manager by complying with identified responsibilities and expectations (RACI - Responsibility, Accountability, Consultation and Information)




  • Ensures robust and timely communication of defined operational/planning activities associated with the execution of daily production




  • Readily adapts to and supports change to meet plan




  • Provides Manufacturing Manager with operational detail and planning as required to comply with production planning and to support Manager's initiatives




  • Drives/Writes/Approves new SOPs, batch records, and/or protocols in support of equipment and manufacturing processes associated with the assigned manufacturing area




  • The direct interface with support groups, including Facility and Process Maintenance, Engineering, Quality Assurance, Quality Control, Planning, Warehousing and Process Development, to ensure the operational status of the manufacturing area in support of published production schedule




  • Supports quality investigations, continuous improvement efforts and Engineering, Maintenance, Quality Control, Quality Operations activities as they directly impact the functionality of the manufacturing area




  • Initiates appropriate action when process deviations occur, authoring investigations when required, to ensure the timely release of product and/or continuity of operation of the manufacturing line




  • Ensures compliance with cGMP in the manufacture of products




  • Ensures maintenance and upkeep of the facility and process employed within the area of responsibility




  • Develops and evaluates employees




  • In conjunction with Manufacturing training support, ensures opportunities for training for new and current operators




  • Ensures qualification of operators, consistent with SOPs, to support cGMP manufacturing of pharmaceutical product




  • Participates in establishing expectations and goals for individuals and for team; Provides regular feedback and ensures accountability




  • Ensures all direct reports have clear goals, and meets with them regularly to review the goals and redirect work as needed




  • Conducts performance review process for direct reports




  • Fosters team environment through regular communication and conflict resolution




  • Responsible for safety compliance for assigned shift




  • Technical writing skills in support of daily operations and personnel management processes




SKILLS/ABILITIES:




  • Demonstrated experience leading/supervising employees in a pharmaceutical manufacturing environment comparable to the proposed manufacturing area




  • Demonstrates advanced skills particularly in operational planning, product/process impact, personnel management, multi-tasking, delegation and interpersonal relationship building




  • Thorough knowledge of and experience in a manufacturing environment operating under cGMP




  • Advanced knowledge of the Scientific Method




  • Advanced knowledge of and adherence to current GMPs




  • Basic knowledge of chemistry , biology, math, steam/dry heat sterilization theories




  • Basic knowledge of HAZCOM, RCRA and other Safety requirements




  • Demonstrated mechanical aptitude




  • Ability to operate all types of production equipment (i.e. various manual valves, automation panels, parts washer, glovebox, etc.)




  • Able to comply with procedures for gowning in controlled or aseptic areas




  • Ability to lift/move 50 lbs. overhead (team lift 100 lbs.)




  • Excellent verbal and written communication skills; detailed-oriented




  • Excellent documentation skills




  • General knowledge pharmaceutical finished product manufacture standards




  • Ability to read, understand and accurately follow company SOPs and guidelines




  • Ability to interview, hire and develop personnel




  • Must be able to accomplish assignments on time




PERSONAL ATTRIBUTES:




  • Leadership-oriented




  • Team Player committed to quality and working effectively with others




  • Motivated self-starter




  • Detail and results oriented




  • Dependable




  • Well organized




  • Efficient worker with good communication skills




  • Willing to learn new tasks, skills




  • Readily adapts to changing job duties




  • Positive attitude




  • Displays understanding of and promotes company and customer objectives




EDUCATION AND EXPERIENCE:




  • 5 years experience in regulated industry, preferably in cGMP pharmaceutical manufacturing or development environment




  • Minimum of 3-5 years of supervisory experience




  • AS/BS degree in Engineering, Scientific Discipline or Business preferred




Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.


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Experience Level:
Mid-Senior Level

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