Manufacturing Supervisor

Pacira Pharmaceuticals   •  

San Diego, CA

Industry: Pharmaceuticals & Biotech

  •  

5 - 7 years

Posted 116 days ago

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.