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This position will be responsible for the development and maintenance of document management systems in terms of applicable regulations and industry practices. Responsible for developing and implementing procedures and practices for archiving completed batch records, and related controlled documentation. Responsible for establishing and implementing training program for all employees supporting GXP operations.
A successful Project Manager/Sr Project Manager candidate will be accountable to support all the programs within our company portfolio. This individual will successfully lead a team to execute the plans against the project timelines, finances, and commitments. This individual will be responsible to communicate the project plans and learnings across the organization to drive further program development within clinical and R&D.
The candidate will be responsible for directing and mentoring a dynamic team (dotted line), on a wide spectrum of activities to better navigate the multi-faceted product development / clinical process and product management lifecycle. We also encourage our project managers to continue to optimize programs while leading cross functional teams through innovation to commercialization.
Project Managers will manage different aspects of our projects: scope, schedule, finance, risk, quality and resources.
Maintaining and continually developing the Ocular Therapeutix quality management system to ensure all stages throughout the product lifecycle (development through discontinuation) are conducted in compliance with global GMPs applicable to the stage and to ensure the company is GMP inspection ready at all times.
Greet visitors at the reception area. Provide administrative support to management and assist in various departmental projects The successful candidate will be able to succeed in a fast paced environment, be flexible, and have multitasking skills to manage competing priorities. In addition, this role will also provide backup support to the Building Manager when they are out of the office.
will be responsible for ensuring GxP computerized systems, including Cloud/Server based applications, are validated and controlled in compliance with industry standards. The CSV Engineer will be primarily responsible for validating manufacturing, laboratory, and enterprise computerized systems. Other responsibilities include drafting system documentation, developing functional requirement specifications, and providing validation lifecycle management.
The position is set in a dynamic, fast-paced start-up environment and shall require the individual to work on a broad range of tasks.
Responsible for the physical and administrative tasks involved in the shipping, receiving, kitting, and distribution of materials, components, supplies and equipment. Performs inspection of all shipments received against purchase orders, and specifications. Maintains records of received goods and returns/rejects unsatisfactory items as necessary. Ability to lift heavy items. Prepares and maintains records of product shipped/received. Uses ERP/MRP system for all inventory transactions. Examines, stocks and distributes materials to inventory and manufacturing team. Prepare kitting for departments as requested.
As the Buyer/Planner, you will be responsible for production planning, purchasing, and fulfillment. Working cross-functionally with several departments, you will also support Sales, Operations, and Engineering, as well as interface with Finance/Accounting, to drive production.
This position will be a hands-on leadership role responsible for suporting the hiring and development of our facilities engineering team. Work with metrology and maintenance personnel as Ocular builds our Facilities Engineering team. The position requires hands-on engineering support for sustaining and expanding buildings, facilities, utilities and equipment in support of formulation, development and commercialization of innovative therapies at a GMP biopharmaceutical and medical device manufacturing plant.
Greet visitors at the reception area. Provide administrative support to management and assist in various departmental projects. The successful candidate will be able to succeed in a fast paced environment, be flexible, and have multitasking skills to manage competing priorities. In addition, this role will also provide backup support to the Building Manager when they are out of the office.
Responsible for managing early development and clinical manufacturing operations. Ensure process development operations are conducted in accordance with phase appropriate regulatory and cGLP or cGMP compliance.
Lead a team dedicated to bringing innovative products through clinical production as a mechanism to determine product proof of concept in clinical trials.
Instill a culture of continuous improvement within production operations, and foster team growth environment. Collaborate with Regulatory/Quality, Facilities, Research and MSAT on project plans and the successful production execution of feasibility builds, early and late phase clinical products, along with supporting commercial lifecycle as needed.
This individual will be upbeat and thrives in a team-oriented, fast-paced, and cross-disciplinary small biotech company environment. The manager of the pilot plant, will need to be technically savvy with the expertise to prioritize programs and activities based on the un-met medical need
and corporate strategy.
We are seeking an experienced and motivated Process Engineer to join the Manufacturing, Sciences & Technology (MSAT) team. The individual is responsible for providing technical support to Ocular Therapeutix’ novel hydrogel drug products in late stage clinical development and commercial manufacturing. This role includes all stages of process development and validation, including process design, process qualification and continued process verification. This individual will serve as Subject Matter Expert and will provide technical expertise and support to the Manufacturing Plant. Responsibilities include leading medium to large projects such as new product introductions, site transfers, manufacturing investigations, raw material qualifications, and implementation of automated productions systems. In this role you will work collaboratively with group and cross-functional project team members and oversee the execution of project tasks and activities when in a leadership role. The position is set in a dynamic and fast-paced environment.
Execute drug manufacturing project activities for hydrogel-based drug product candidates. The role includes but is not limited to formulation and manufacturing process improvements, product design and evaluation, and GMP manufacture of clinical trial material and commercial product. This individual will execute assigned project activities and work with project team members to develop and manufacture the drug products. The position is set in a dynamic and fast-paced environment.
Critical areas of focus will be execution of manufacturing to support early stage pre-clinical and clinical programs. Evaluation of process scale up for later phase and commercial manufacturing for efficient and consistent manufacturing process.
This role will execute on moderately complex research and development activities as assigned by management, including analysis of drug samples using various analytical techniques. Work with project team members to support development of drug delivery platform products. Participate in formulation support, method development and validation, the maintenance and troubleshooting of laboratory equipment, and where necessary, coordinate outsourcing of testing and method development with vendors.
We are seeking an experienced R&D Engineer/Scientist to execute drug development project activities for hydrogel-based drug product candidates. The role includes but is not limited to formulation and process development, product design, evaluation and pre-clinical program execution. This individual will execute assigned project activities and work with project team members to develop formulations for new drug products.
This experienced engineer is responsible for executing and overseeing drug development project activities for hydrogel-based drug product candidates. The role includes but is not limited to ownership of formulation and process development activities to support project team goals, cross-functional communication and coordination of activity execution with others on the CMC team, product design, evaluation, and GMP manufacture of clinical trial material. This individual will contribute to designing and execution of project activities and will require working closely with project team members to develop and manufacture the drug products/device. They will also oversee the execution of project tasks and monitor the activities and deliverables of project activities in a leadership role. The position is set in a dynamic and fast-paced environment.
Critical areas of focus will be technical transfers, scale up and new process development. Industrialization and implementation of robust commercial manufacturing processes will be key to this position. Incorporation of automation into a complex manual process will be the area of focus for this experienced engineer.
The Key Account Manager (KAM) is responsible for the successful promotion of approved products and helping define the Company as a leader within the ophthalmology community. This is done through development, cultivation and maintenance of long-term relationships with ophthalmic surgeons and all relevant personnel at ambulatory surgery center accounts. The KAM works on executing both clinical training of the product as well as understanding and assisting accounts with the reimbursement process to position products for rapid uptake. To accomplish this, successful performance will involve facilitating patient and provider access of product, and require the ability to help accounts understand and manage local payer reimbursement policies.
This role requires interaction with a variety of customers including; physicians (primarily surgeons), nurses, billing staff, administrators, financial personnel, i.e., any relevant stakeholder within ASCs and hospital outpatient departments. The KAM works with his/her assigned Area Sales Director and Reimbursement Manager to develop a local strategy and business plan that maximizes the opportunity across the assigned territory.
Work with other departments to ensure the quality of products and compliance to internal procedures and external standards. Review batch records from production and testing and records for product development. Review, develop, and improve quality system procedures, specifications, and test methods. Process and provide oversight for elements of the quality system such as change control, deviations, CAPAs, and product complaints. May support investigations of quality issues or perform quality audits.