What are the responsibilities and job description for the Director, Operations, Corneal Health position at Glaukos Corporation?
The Director, Pharmaceutical Operations, based in Burlington will be responsible to manage and coordinate manufacturing and supply chain activities of pharmaceutical products for clinical or commercial distribution. The position requires close coordination with external vendors as well as key internal functions such as R&D, CMC, Regulatory, QA, Business Development, Finance and Legal.
Responsibilities:
* Manage and coordinate manufacturing and supply chain activities in support of development, clinical and marketed products.
* Provide expertise in support of internal qualifications and process validations. Provide expertise in support of qualifications of CRO's, CMO's, CPO's, 3PL's and related vendors in support of product manufacturing and supply chain.
* Key contributor on pharma program teams interacting with Pilot Operations and CMC on Tech Transfers. Key Operations voice during Stage / Gate Reviews with R&D teams. Provide an Operations voice with respect to manufacturing strategies, manufacturing process design, equipment design, capability and scale up.
* Manage technology transfer activities, process optimization, formulation development, and other activities related to pharmaceutical manufacturing (internal or external).
* Capacity planning, including insourcing and outsourcing decisions, and make vs. buy decisions. Manage supply risk based on technical as well as business uncertainties.
* Manage work of CMO's, potentially on-site at CMO, promoting safe work practices and generally contributing to the education and training of other group members.
* Support internal QA/QC functions with analytical method transfer to CMO as needed.
* Collaborate with internal QA function to review 210/211 Quality System and make improvements as needed.
* Ensure adequate equipment, personnel and facilities are available. Ensure appropriate CGMP's are maintained.
* Review and approve batch records, raw material specifications, and process-related vendor change controls and deviations.
* Participate in all tech transfer and CMC project teams to ensure successful manufacture of product
* Ensure appropriate CGMP's are maintained (internal or CMO).
* With input from Development and Commercial team, support forecast to external vendors and ensure that the company's drug products are manufactured and packaged in compliance with the applicable cGMP and related (e.g., environmental) regulations. Ensure adequate inventories of raw materials are available as required. Develop and execute capacity planning model including justification for equipment and facilities as required
* Track budgets, proposals, purchase orders, invoices and payments to related Pharma Operations functions in timely manner. Provide support of project financial budget periodically and provide necessary information to project leads, Department management and/or accounting as required.
* Assist in the leading the manufacturing sections of CMC Section-related documentation by compiling/assembling appropriate data for submissions to FDA and other regulatory authorities .
* Support and interact closely with the R&D / Project Management groups to complete projects based on company timelines as well as the finance group to keep track of proposals, purchase orders, invoices and payments.
* Support/Manage shipment, packaging and distribution activities at CPO and 3PL. Track and manage inventory movement across vendors.
* Interact effectively with Project Team members, senior management, FDA, and other governmental agencies as appropriate.
* This role will require a mix of tactical and strategic decision making. This role will have influence in Organization Design and expanding the Pharma Operations Organization.
Required Skills:
* Must have strong technical understanding of upstream and downstream manufacturing processes and applicable unit operations in commercial manufacturing. Knowledge of aseptic fill is desired .
* Must have extensive technology transfer experience.
* Must have background knowledge of cGMPs, ICH guidelines and knowledge of CMC regulations for new drug submissions, both domestic and international.
* Experience with formulation and analytical method development is desired.
* Prior experience working with virtual CRO/CMO/CPO's is desired.
* Must be flexible, able to multitask across activities, a strong team player, he/she should have excellent interpersonal skills to harmoniously interact with other employees and development functions.
* Initiative and persistence to drive the completion of open items to meet timelines.
* Must be strongly committed to achieving a quality work product with an unwavering adherence to cGMPs, compliance and other quality requirements
* 8 to 10 years in pharmaceutical manufacturing and supply chain, injectable experience preferred.
* Must have a minimum of 3 years management experience and understanding of pharmaceutical manufacturing operations, QC, QA, RA and other functions involved in the manufacturing of API and Drug Product.
* This role requires periodic travel and availability to work evenings and weekends, as required.
Education:
* Bachelor's degree (MS preferred) preferably in Engineering or Health Sciences
Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.