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The Senior Manager Quality Engineering will collaborate with the Validation group, Research / Development, Analytical Method Development, Quality Control, and system/equipment owners to ensure the quality of products and compliance to internal procedures and external standards. Provides technical review and quality oversight of projects, cleaning validation strategy, equipment, utility, process qualification/validation documents to support clinical and commercial manufacturing. Review, develop, and improve quality system procedures, specifications, and test methods. May support other elements of the quality system such as change control or deviations. This position will report to the Senior Director, Quality Assurance.
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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.
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We are seeking an experienced and motivated R&D Engineer/Scientist to join our Drug Product Development Team. This individual is responsible for formulation, process development and scale-up of drug delivery candidates including the manufacture of preclinical and early phase clinical trial materials utilizing the company’s hydrogel-based drug delivery technology. In this role you will work collaboratively with group and cross-functional project team members and will oversee the execution of project tasks and activities when in a leadership role.
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Experienced engineer/scientist to execute drug product/process development project activities for hydrogel-based candidates. The role includes but is not limited to product design and evaluation, manufacturing process development, line layout and equipment procurement, and GMP manufacturing of clinical trial material. This individual will execute assigned project activities and work with project team members to develop and manufacture the drug products. They may oversee the execution of project tasks and monitor the activities and deliverables of project aspects 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 an area of focus for this experienced engineer/scientist.
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This position is responsible for overseeing the quality management system supporting production operations, ensuring regulatory compliance to applicable CFRs and international standards, and continued alignment with Ocular standards and strategic quality initiatives. The Director, Quality Assurance will provide leadership and guidance for personnel within quality assurance operations and serve as support and liaison for other departments.
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The Field Reimbursement Manager (FRM) is a regionally aligned, field-based position that provides reimbursement education and support for customers that utilize DEXTENZA®(and other future products) from Ocular Therapeutix. Customers may include Healthcare Providers (HCPs) within offices, ambulatory surgery centers (ASCs), hospital outpatient departments (HOPDs), and other appropriate site-of-care facilities as well as specialty pharmacies. The FRM will work closely with internal/external business partners including HCPs, billing and coding staff and other professionals involved in securing appropriate Access & Reimbursement for the use of DEXTENZA®.
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Responsible for maintaining quality standards for our pharmaceutical and device products by leading and managing day-to-day activities for the Microbiology group. This includes ownership of the Environmental Monitoring program as well as the in-process and release testing of raw materials and drug products.Provides QC microbiological guidance and support throughout the company.
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The Manager, Calibration & Planning/Scheduling will be responsible for the management of the Metrology/Calibration Program and the Computerized Maintenance Management System (CMMS) in support of formulation, development and commercialization of innovative therapies at a GMP biopharmaceutical manufacturing plant.
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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.
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The Field Reimbursement Manager (FRM) is a regionally aligned, field-based position that provides reimbursement education and support for customers that utilize DEXTENZA®(and other future products) from Ocular Therapeutix. Customers may include Healthcare Providers (HCPs) within offices, ambulatory surgery centers (ASCs), hospital outpatient departments (HOPDs), and other appropriate site-of-care facilities as well as specialty pharmacies. The FRM will work closely with internal/external business partners including HCPs, billing and coding staff and other professionals involved in securing appropriate Access & Reimbursement for the use of DEXTENZA®.
