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The Process Development Engineer I/II position within the Manufacturing Science and Technology (MSAT) group is responsible for the clinical development and process scale-up of new medical devices for the delivery of Ocular Therapeutix hydrogel drug products. This role is responsible for development of clinical phase manufacturing processes to support the production of both clinical stage medical devices and drug products. The role is also responsible for product specification, design changes, design verification and validation and management of process and product documentation. The position is set in a dynamic and fast-paced environment.
Critical areas of focus will include implementation of process automation in support of late-stage clinical development, scale-up and commercial launch. This role will lead their implementation in the manufacturing facility with support from senior team members. Additionally, the Process Development Engineer will lead projects in the areas of continuous improvement and process control. This role will have a meaningful impact on the success of the organization and will require qualified candidates to possess motivation to see their concepts and vision actualized through the Ocular Therapeutix new product development pipeline.
Ocular Therapeutix cleaning technicians are responsible to maintain our GXP facilities to the highest of regulatory compliance in accordance to 21 CFR 211.42. Our cleaning technicians will be required to perform at the highest level of control to prevent cross contamination or safety risks for our employees and patients. This position is responsible for cleaning and maintaining critical areas of manufacturing/research facilities at Ocular Therapeutix using FDA regulated cleaning, training and documentation processes. Our cleaning technicians will be working in clean room environments as well as research and development, and laboratories to ensure proper cleaning in all facility locations.
Position Summary:
Manage day-to-day activities of an Analytical Development team comprised of one or more analytical chemists. Represent Analytical Development in cross-functional project and CMC teams. Oversee the development of Scientifically sound, high-quality analytical methods to support drug substance or drug product testing which meet phase-appropriate requirements. Facilitate transfer of appropriate methods to Quality Control.
Position Summary:
The Training Coordinator supports all training activities within the Quality Systems team for the entire company. This includes administering the electronic Learning Management System (eLMS), managing training records, facilitating and conducting training whilst supporting the document revision process.
Position Summary:
Lead clinical and laboratory compliance quality assurance activities to ensure Ocular Therapeutix processes are compliant against the applicable regulations/directives (GCP, GLP), protocols, quality agreements and/or Standard Operating Procedures. Lead and provide oversite of Clinical Quality Assurance (CQA) approvals, Quality Data Integrity Reviews (DIR) and support internal/external auditing programs.
Support the GxP training and development of Ocular Therapeutix employees.
The Field Reimbursement Manager (FRM) is a regionally aligned, field-based position that provides access and reimbursement education and support for customers that utilize DEXTENZA® from Ocular Therapeutix. Customers will include Healthcare Providers (HCPs) and staff within offices, ambulatory surgery centers (ASCs), hospital outpatient departments (HOPDs), and other appropriate site-of-care facilities. The FRM will work closely with internal/external stakeholders including HCPs, billing and coding staff, revenue cycle managers and other professionals involved in securing appropriate Access & Reimbursement for the use of DEXTENZA®.
The FRM provides support through (1) product-specific provider reimbursement support, (2) coordination of HUB reimbursement services, and (3) managing payer/coverage pull-through initiatives. The FRM must have a solid working knowledge of buy-and-bill products with Medical (Part-B) reimbursement, as well as a clear understanding of all Public and Private insurance plans and benefit design. Additionally, the candidate should have a working knowledge of the “Medicare Pass-Through” program.
The FRM is expected to be a subject matter expert on access & reimbursement processes for a product with a permanent J Code and paid by the Medical benefit (i.e., pass-through, benefit verification, claim assistance, and appeals). In addition, the FRM needs to build and maintain strong relationships with provider practices and facilities, while implementing and managing field reimbursement responsibilities. The FRM role includes a high degree of communication, account coordination and cross-functional collaboration.
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.
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.
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.
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.
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.
Manage the planning and execution of R&D sustained release/drug delivery activities of the company’s hydrogel-based drug product candidates including new technology and initial concept evaluation, prototype development and testing, preclinical execution, technical reporting and documentation. Work with management and project team members to design and implement research or initial proof of concept program plans. Oversee the execution of project tasks relevant to R&D and monitor the activities and deliverables.
Position Summary:
The Document Control / Training Specialist supports all activities within the Document Control and Training team, including administering the electronic Document Management System (eDMS), supporting the document revision process, controlled document issuance, archival, customer support, establishment of training courses within the eDMS, and logbook and data collection form control.
Position Summary:
This highly visible role is responsible for the accounting, audit, financial reporting and compliance processes. The Controller is a key member of the Finance team and interfaces regularly with the Company senior leadership and audit partners. In this public company, you will direct the accounting team and ensure monthly and quarterly deadlines are met. The Controller must be able to effectively partner with other senior members of the finance team and possess superior people management skills to develop staff and encourage the team’s growth by providing regular performance feedback and including staff in planning, decision-making and establishing an expectation of continuous process improvement. This position reports to the CFO.
Position Summary:
The Document Control / Training Specialist supports all activities within the Document Control and Training team, including administering the electronic Document Management System (eDMS), supporting the document revision process, controlled document issuance, archival, customer support, establishment of training courses within the eDMS, and logbook and data collection form control.
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.
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.
The Manager, Validation shall provide strategic, technical leadership and accountability for validations within the organization including commissioning, qualification, and maintenance of the validated state for all direct impact manufacturing systems used to support the clinical development and commercialization of multiple therapeutic drug delivery platform. The position is responsible for coordination and execution of validation studies for manufacturing process, cleaning process, and GMP equipment including autoclaves, glove box, ovens, packaging equipment, incubators, lyophilizers, clean rooms, cold rooms, and other equipment/systems as assigned.
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 supervising clinical and commercial manufacturing operations. Ensure production operations are conducted in accordance with regulatory and cGMP compliance, while delivering to the production plan of record. Instill a culture of continuous improvement within production operations, and foster team growth environment. Collaborate with Regulatory/Quality, Facilities, and Development with regards to project plans and the successful production execution of late phase clinical, new product launch and sustainable commercial manufacturing activities.
Position Summary:
The Associate Director, Clinical Operations assists function leadership with day to day oversight of the teams executing clinical studies within a clinical program or multiple clinical programs. This position works closely clinical study leads to ensure studies are inspection ready throughout their lifecycle.