Manufacturing Supervisor

Technical Operations San Diego, CA


Description

 

 

Summary:

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:

The following statements are intended to describe the general nature and level of work being performed by an individual assigned to this job. Other duties may be assigned.

  • 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.\
  • (insert people management skills/requirements)

 

Supervisory Responsibilities:

Supervise several staff from entry operator to lead-level.

Interaction:

The incumbent will be required to Operations, Quality, Engineering, and Process Research and Development groups within Pacira.

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.

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill and/or ability required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

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.

 

Physical Demands:

While performing the duties of this job, the employee is regularly required to sit, talk, move between spaces, reach with hands and arms and stoop.  Close vision and the need to focus on computer screen, use of hands, fingers and wrist to type on keyboard and manipulate mouse.  Will need to lift and move items weighing up to 50 pounds.

Employee is required to work in a cleanroom environment, which requires gowning consisting of coverall, foot and head coverings, facemask, and gloves.  Noise level is moderate with consistent equipment operation.

 

Work Environment:

The work setting is consistent of a typical pharmaceutical manufacturing environment with production areas, offices, and cubicles.

 

EEO Statement:

Pacira is proud to be an Equal Opportunity Employer and does not discriminate against applicants because of race, color, religion, sex (including gender identity, sexual orientation, and pregnancy), national origin, age (40 or older), veteran status, disability or genetic information, or any other characteristic protected under applicable federal, state, or local law.

At Pacira we are committed to intentionally cultivating a culture of inclusion where all feel welcomed and valued for their background, perspectives, and experiences. We hold one another accountable to promote trust and transparency in support of our communities and collective purpose.