GMP Operations Manager

Overview: Position Summary:
The GMP Operations Manager is responsible for providing direct and detailed GMP manufacturing support through commercial and all phases of the clinical production campaigns. The GMP Operations Manager will build a continuous learning environment within manufacturing and with department colleagues in development and technical transfer and support, sharing of best practices and learning opportunities and building robust readiness and execution processes to drive sustainable right-first-time performance all processes related to the manufacture of Ocular Therapeutix products.
Responsibilities: Principal Duties and Responsibilities include the following:

• 
  Management of GxP training for Operations including but not limited to manufacturing processes, procedures and GxP systems.
• Scheduling of training opportunities for manufacturing and process to enhance team capabilities to ensure consistent execution of manufacturing.
• Monitor cGMP and cGDP compliance and adhere to guidelines for all production activities.
• Supervise overall manufacturing activities by ensuring that clinical and commercial manufacturing processes are appropriately scheduled.
• Develop quality metrics and perform cleaning and sanitization audits.
• Provide leadership, guidance, and direction to staff to create a GxP-centric organization.
• Drive continuous improvement and operational excellence culture thru self-detecting and self-correcting processes and systems and instilling strong ownership and accountability.
• Identify areas and procedures in need of improvement and implement corrective actions and processes to achieve sustaining results.
• Support manufacturing teams by following good training and mentoring practices.
• Ensure the successful technical transfer of projects from the Tech transfer group to the GMP production group.
• Maintain a safe workplace that complies with company policies and standards.
• Provide periodic reports to evaluate performance in the areas of process improvements, cost savings and cost avoidances.
• Establish and maintain key performance indicators in alignment with department and product supply goals, maintain and report applicable area or organizational metrics.
• Maintain manufacturing department training curricula and metrics requirements.
• May create, revise, and edit SOP, batch records, and specs as needed.
• Complete documentation (batch records, process routers, forms, etc.) and review executed documentation as required throughout the manufacturing process.
• Troubleshoot issues as they arise related to equipment and/or manufacturing processes.
• Manage Quality Events and associated documentation to ensure completion in a timely manner. Properly identify deviations and accurately document the events, establishing and executing appropriate CAPAs to address any issues. Work cross functionally to arrive at corrective actions and implement the identified action.
• Perform other duties as required.

Supervisory Responsibilities:

• Oversight of all training related activities for Operations.
• Overall supervision of employees performing GxP processes.

Qualifications: Qualification Requirements:

• Bachelor’s Degree in a Science field or equivalent preferred
• 5 – 7 years’ prior experience in the pharmaceutical industry
• Clean room experience required
• Chemical handling and solution preparation experience preferred
• Basic computer knowledge, such as using Microsoft Word, Outlook and Excel
• Must have very good written and oral communication skills as well as willingness to learn
• Working knowledge of GxP Documentation, cGDPs, ISO Standards, FDA regulations and corrective action procedures
• Ability to interact with all manufacturing management team, manufacturing engineers, QC, MSAT, Product Development and other personnel
• Excellent organizational skills and attention to detail with the ability to multitask
• Proven ability to work independently, in a fast-paced, start-up environment.

• Provide leadership to manufacturing team while addressing concerns and individuality of team members.
• Ability to ensure GxP compliance to procedures and regulations.
• Ability to evaluate manufacturing schedule and appropriately assign operators and roles.