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.