5 operations supervisor jobs found in Wilmington

Alkermes, Inc. Key Responsibilities Lead and supervise daily execution of tasks to support the published production plan, ensuring completion through Team Leads and Manufacturing Associates. Provide hands-on leadership, coaching, and feedback to production teams across all shifts. Ensure robust and timely communication of operational and planning activities. Support the Line Manager in fulfilling RACI responsibilities (Responsibility, Accountability, Consultation, Information). Drive, write, and approve new SOPs, batch records, and protocols for equipment and manufacturing processes. Interface with support groups (Maintenance, Engineering, Quality Assurance/Control, Planning, Warehousing, Process Development) to maintain operational status and support production schedules. Support quality investigations, continuous improvement, and engineering/maintenance/quality activities. Initiate and author investigations for process deviations, ensuring timely product release...

Alkermes, Inc. This position reports to a Supervisor, Manufacturing. Position Summary: This entry-level position involves working with a small team in a GMP environment to manufacture commercial and/or clinical-scale batches. Essential Functions: The essential functions of this position include: Production, bulk packaging, and inspection of pharmaceutical drug formulations Assisting with facility cleaning and operational maintenance Cleaning all manufacturing equipment and areas Assisting with facility and process validations as required Assisting with environmental and water system monitoring as required Assisting with RCRA and safety inspections as required Documenting all work as required by cGMPs and GDPs on a timely basis Reading and following all Company SOPs and guidelines Abiding by all safety requirements as defined by the company Completing other tasks as assigned by supervision Preferred Qualifications: Basic...

Alkermes, Inc. POSITION SUMMARY The QC Team Lead will join the microbiology group to provide technical supervision, coordinate and track projects, act as point person on CMC Teams and validation projects. Responsibilities will also include reviewing, reporting test results as related to validation protocols. Direct Support for Method development and optimization for all Microbiology methodology and testing such as Endotoxin, Sterility, Biological Indicators, Microbial Limits, Bioburden. Suggest and implement new technologies and equipment for Microbiological testing. QUALIFICATIONS A four year degree in science, preferably in Biology or Microbiology with minimum 8 years' experience in the pharmaceutical industry Experience with the execution of test methods for sterile and non-sterile drugs, raw materials, components and in-process testing. This includes the methods described in USP Chapters 61, 62, 71, 85, 788 and relevant informational chapters Critical thinker,...

Alkermes, Inc. The hours for this position would be 9:30 pm to 8:00 am, Monday through Thursday nights. Position Summary: This entry-level position involves working with a small team in a GMP environment to manufacture commercial and/or clinical-scale batches. Essential Functions: The essential functions of this position include: Production, bulk packaging, and inspection of pharmaceutical drug formulations Assisting with facility cleaning and operational maintenance Cleaning all manufacturing equipment and areas Assisting with facility and process validations as required Assisting with environmental and water system monitoring as required Assisting with RCRA and safety inspections as required Documenting all work as required by cGMPs and GDPs on a timely basis Reading and following all Company SOPs and guidelines Abiding by all safety requirements as defined by the company Completing other tasks as assigned by supervision...

Alkermes, Inc. Director, Validation Overview Provide leadership for all validation activities within Alkermes organization including clinical and commercial manufacturing support via facilities/equipment/filter/cleaning & manufacturing process validation, capital project support via commissioning and qualification, automation systems qualification, and oversite of entire validation program. Position includes management responsibilities for internal and contractual employees. This position description/summary reflects management's assignment of essential functions; it does not prescribe or restrict the tasks that may be assigned. Responsibilities Development and oversight of site validation program to ensure compliance with cGMPs, FDA and EU guidelines. This includes guideline and policy development and enforcement. Responsible for preparation and management of side validation budget which includes clinical & commercial operations support and capital...