Manufacturing Supervisor

Pacira Pharmaceuticals   •  

San Diego, CA

Industry: Pharmaceuticals & Biotech

  •  

5 - 7 years

Posted 163 days ago

This job is no longer available.

The purpose of this position is to lead and provide supervisory oversight to production areas for the sterile production of liquid injectable, sustained- release pharmaceutical products under cGMP regulations.

The selected candidate will be an established, technically competent professional who will supervise pharmaceutical production operations at our state-of-the art San Diego facilities.

Essential Duties & Responsibilities:

 

  • Supervise the production process. Monitor adherence to policies and procedures.
  • Lead and coach a team of operators to meet production schedules, quality standards, and to resolve production issues,
  • Coordinate with manufacturing leads, Manufacturing management, and with support groups to assure production activities occur on schedule and to specifications.
  • Audit internal systems and procedures for compliance to GMP and EH&S. Look for opportunities for continued improvement.
  • Assist area management with developing capital and resource requirements plans.
  • Facilitate, manage, and execute manufacturing activities required for validation studies, process characterization,  technology transfer, and commercial or clinical operations
  • Assisting in regulatory inspection preparation and inspections.
  • Create cooperative processes and systems with support departments to schedule activities and/or resolve issues.
  • Participate in all departmental media qualification requirements; become fully qualified and proficient in all aspects of manufacturing.
  • Review GMP documentation such as batch records, forms, charts, logs. Review and approve incident reports and investigations in Track Wise.
  • Form and support internal and/or cross functional teams for continuous improvement.
  • Interacting with outside vendors.
  • Serving as the central point of contact for operational issues.
  • Develop, oversee and administer training for new employees, maintain skills of current employees, and advance skills of current employees as part of career development.
  • Work with department management to develop area metrics and goals.
  • Provide area oversight for EH&S policies and procedures. Liaise with the departmental safety committee member to coordinate audits and committee initiatives.
  • Maintain proficiency in cleanroom gowning and procedures
  • 12 hour shift schedule

 

Education and Experience:

  • 3 years of leadership experience and a bachelor’s degree in a technical discipline from an accredited college or university is required  OR:
  •  7 years leadership experience in a regulated environment.
  • A minimum of 5 years of industry experience in a supervisory role is also required.

 

Knowledge, Skills, and Abilities:

The selected candidate shall possess the following fundamental skills:

  • Demonstrated experience in a GMP manufacturing environment, understanding of GMP, and quality leadership on the manufacturing floor.
  • Performance as a “hands on” supervisor with a strong pharmaceutical/biopharmaceutical manufacturing background.
  • A good team player; able to develop and coach teams; experienced with conflict resolution;  possess good interpersonal skills.
  • Ability to grasp complex concepts and systems and the documentation that accompanies them.
  • Self directed, logical, organized and able to work with little direct supervision in a team environment in order to meet the production schedule.
  • Must have relevant industry experience in a supervisory capacity.
  • Flexible, decisive, and able to manage changing and multiple priorities. 
  • Must possess strong written and verbal English communication skills: able to effectively communicate to the rest of the team; author memos, reports, SOP’s.
  • Experienced in training operators.
  • Good time management skills are a must.