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  • San Diego, CA

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Director of Manufacturing

Apex Life Sciences • San Diego, CA

Posted 1 day ago

Job Snapshot

Other Great Industries
Management, Manufacturing


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Job Description

Our client, a pharmaceutical company, is seeking a Director of Manufacturing.

Director of Manufacturing

Responsible for all aspects of product scale-up, validation and commercial manufacture of RX and OTC products.

These Responsibilities may include but are not limited to:

  1. Coordinating with all departments and leading team to complete scale -up, validation and launch of a series of new generic oral dosage forms. (May be expanded to include sterile products)
    1. Product and process validation protocol development, execution and reporting
    2. Cleaning validation protocol development, execution and reporting
    3. New equipment IQ/OQ/PQ (protocol development, execution, reporting)
  2. Oversight of the creation and maintenance of production schedules with the assistance of the Manufacturing Supervisor(s) and concurrence of the management group.
    1. Scheduling and Supervision of Manufacturing Supervisors
    2. Oversight of Manufacturing Supervisors in the final review of batch documentation
    3. In cooperation with Manufacturing Supervisor(s) and Manufacturing Associates, ensures proper maintenance of all manufacturing equipment
    4. Training of Manufacturing Supervisors and Manufacturing Associates
    5. Oversight of inventory control to the extent that the Director of Manufacturing will be responsible for the receiving process for raw materials and will interact with the Manufacturing Supervisors, Purchasing Group, Controller, and QC/QA to ensure that materials are available as needed
    6. Coordinates activities with outside suppliers and consultants to ensure the delivery of supplies or services needed to meet scheduled timelines
  3. Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per cGMP
  4. Ensures a safe manufacturing environment in cooperation with the Corporate Safety Officer.
  5.  Responsible for quoting and establishing feasibility for new business opportunities including new product cost analysis
  6. Oversee Facility Design and Construction
  7. Reports Progress and Trends to the Vice President, Chief Scientific and Technical Officer

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [Click Here to Email Your Resumé] or 844-463-6178.

Job ID: 825074
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