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Responsible for providing administrative support to the Quality organization and other departments at the site and supporting the reception area, offices at the site and break room.
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The Manufacturing Engineer II/III shall be responsible for technology transfer of innovative ophthalmic drug products from Process Development (PD) to Plant Manufacturing (MFG). This position will work closely with PD to understand clinical manufacturing processes as a basis for developing and executing scale-up and transfer plans. The Manufacturing Engineer II/III is responsible for defining late stage clinical and commercial manufacturing processes and growing process knowledge through the execution of engineering studies and designed experiments. This position is responsible for specification, design review, acceptance testing, and other activities related to the procurement of capital equipment. The position is the technical lead within the manufacturing organization for process knowledge and understanding of process performance, including definition of Critical Process Parameters (CPPs) and implementation of process control strategy.
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. This position requires strong interpersonal and organizational skills, and the ability to actively collaborate with colleagues across functions.
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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.
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Ensure the quality of products and compliance to internal procedures and external standards. Provide quality oversight to GMP processes through walkthroughs, review of executed batch records and associated documentation, and review of analytical data. Continuously improve quality system procedures related to these tasks.
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This position is responsible for performing all processes related to manufacture of Ocular Therapeutix products, including early stage clinical trial builds as well as commercial production builds.
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This position reports to the Director of Clinical Quality Assurance and will be responsible for all Quality Assurance GLP activities and provide a supporting role in GCP activities. The primary responsibilities will be to ensure quality and compliance of Ocular Therapeutix-sponsored nonclinical and clinical studies with respect to Standard Operating Procedures, applicable regulatory requirements (FDA/EU/ICH/country-specific and current industry standards and practices).
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The Medical Science Liaison (MSL) will be responsible for providing scientific and clinical communication and research support for the Ocular portfolio of assets in his or her identified territory. The MSL will establish, develop and maintain scientific exchange with key opinion leaders and other external stakeholders in alignment with the medical affairs strategy. The MSL will support the relevant medical affairs strategy/ies through an in-depth knowledge of the ophthalmology space.
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The Medical Science Liaison (MSL) will be responsible for providing scientific and clinical communication and research support for the Ocular portfolio of assets in his or her identified territory. The MSL will establish, develop and maintain scientific exchange with key opinion leaders and other external stakeholders in alignment with the medical affairs strategy. The MSL will support the relevant medical affairs strategy/ies through an in-depth knowledge of the ophthalmology space.
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The QA Validation Specialist III/Manager will collaborate with the Validation group 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 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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We are seeking a skilled Senior Quality Control Microbiologist to join our team. The candidate must be an SME in microbiological laboratory techniques and have extensive experience supporting an Environmental Monitoring program including the writing of EM Trend reports and assisting with EM Excursion Investigations.
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Provide leadership and guidance as the lead statistician and be accountable for all statistical aspects of clinical studies and submissions, including quality, relevance to regulatory perspective, and scientific validity. Act as key statistical consultant within company. Responsible for oversight of outsourced statistical activities.
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Direct the planning, implementation and execution of Analytical Development activities by providing creative analytical expertise and leadership. This position is responsible for analytical chemistry method development, qualifications and validations, routine testing, and method transfer; as well as similar activities related to other physical testing. To accomplish this, oversight of both in-house and outsourced testing resources is required. This role also has overall accountability for meeting product development teams’ testing needs, supporting associated regulatory filings, as well as managing the testing of clinical product.
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Executes coordination of activities associated with the set-up and management of clinical trials. Responsible for retrieval and management of regulatory documentation for site activation, maintenance, and close-out.
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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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Ensure the quality of products and compliance to internal procedures and external standards in collaboration with cross-functional teams. Review, develop, and improve quality system procedures, specifications, and test methods. Primary responsibility is to oversee change control and related activities including but not limited to deviations, CAPAs, validation. May support investigations of quality issues and perform quality audits as necessary.
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Reporting to the Vice President of Quality Assurance, 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 Senior Director, Quality Assurance will provide leadership and guidance for personnel within quality assurance operations and serve as support and liaison for other departments.
