Alkermes, Inc.
Sr Manufacturing Associate I-Bulk 2nd Shift
Wilmington, OH
Sep 20, 2024
fulltime
Full Job Description

POSITION SUMMARY

High-level position for persons to manufacture commercial scale batches.

MAJOR RESPONSIBILITIES

  • Lead other operators and small groups as directed by the Supervisor.
  • Production, filling, and inspection of pharmaceutical formulations.
  • Assist with facility cleaning and operational maintenance.
  • Assist with facility and process validations as required.
  • Perform aseptic production operations and validations.
  • Assist with environment and water system monitoring as required.
  • Assist with clean room sanitization as required.
  • Assist with RCRA and safety inspections as required.
  • Document all work as required by CGMPs on a timely basis.
  • Read and follow all company SOPs and guidelines.
  • Abide by all safety requirements as defined by the company.
  • Train newly qualifying personnel.
  • Provide coaching and feedback for currently qualified personnel.
  • Other tasks as assigned by the Supervisor.

COMPETENCIES

  • General knowledge of the Scientific Method.
  • General math skills, including simple algebra.
  • Through knowledge of and adherence to Current Good Manufacturing Practices.
  • General knowledge of chemistry and biology.
  • General knowledge of steam/dry heat sterilization theories.
  • General knowledge of HAZCOM, RCRA, and other Safety requirements.
  • Good level of mechanical aptitude; ability to perform minor non-routine equipment adjustments and diagnose improperly operating equipment.
  • General computer word processing/spreadsheet skills.
  • General knowledge of and ability to participate in customer, internal and FDA audits.
  • Excellent documentation skills.
  • Ability to act in a leadership role as production situations demand.
  • Ability to mentor newly hired and progressively qualifying personnel.
  • Detail oriented.
  • Willing to learn new tasks and skills.
  • Works well in a team environment.
  • Respond quickly to assignments.
  • Readily adapts to changing job duties.
  • Manages time well; ability to multi-task.
  • Positive attitude.
  • Effective written and verbal communication skills.
  • Effective trainer (coach).
  • Displays understanding of and promotes company and customer objectives.

Physical Requirements:

  • Occasional periods of repetitive motion.
  • Ability to gown in an aseptic manner for clean room operations. 
  • Walking, lifting, pushing and pulling carts, reaching, climbing, and bending may all be required. 
  • Ability to operate all types of production equipment 
  • Ability to read, understand, and follow company SOP guidelines.
  • Ability to lift/move up to 50 lbs.  Ability to team lift up to 100 lbs.
  • Ability to stand in steel-toed shoes for a minimum of 7 hrs. 

EDUCATION AND EXPERIENCE

Basic Qualifications:

  • High school diploma or equivalent.
  • 4-5 years of experience in a pharmaceutical operation.

Preferred Qualifications:

  • Associate degree or higher in science/technical discipline
  • 4-5 years of experience in a sterile pharmaceutical operation
PDN-9d0d3014-6c66-4b30-b9e8-fd697c336020
Job Information
Job Category:
Facilities
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Sr Manufacturing Associate I-Bulk 2nd Shift
Alkermes, Inc.
Wilmington, OH
Sep 20, 2024
fulltime
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