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Seeking a highly motivated R&D Engineer I to execute development project activities for sustained drug delivery inserts entailing: both formulation and process development, product design and evaluation, preclinical prototype production, manufacturing of clinical test materials, and GMP documentation. This individual will execute program activities as assigned by management and work with project team members to design and implement sustained release drug product development studies. The position is set in a dynamic, fast-paced environment.
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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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Our growing Finance/Accounting team is seeking an Accountant who is primarily responsible for Payroll, Accounts Payable. Other duties may include; assisting in the month-end closing process, audit support and preparation, assisting with the annual budgeting and monthly forecasting, and any additional projects as assigned. Reporting to the Director, Accounting and External Reporting, there will be a myriad of projects that this position will be an integral part.
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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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Reporting to the Director, Commercial Operations and Analytics, this position will have the unique opportunity to manage and implement significant transformations of the Ocular Data Management Systems. This highly visible role will be responsible for working across the US Commercial Organization to develop an overarching Data Management strategy. This position will focus on creating processes for effective data management that will ensure adequacy, accuracy and legitimacy of data. This position will work closely with IT and other vendor partners that are responsible for the ongoing management of the Ocular Data Warehouse, to ensure that those processes are mapped and aligned accordingly.
In addition, this position will work closely with the Manager of CRM & Sales Analytics, the Manager of Forecasting and Customer Insights and other key stakeholders to support strategic and tactical decision-making through in-depth analytics.
The desired candidate for this role must have a track record of expert collaboration and will be a solutions-oriented, self-motivated individual. They will be a highly passionate, team player that will ultimately ensure a first in class data management team.
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We are seeking a skilled Quality Control Analyst III, Microbiologist to join our team. The candidate must be well-versed with general microbiological laboratory techniques, support activities such as Environmental Monitoring of manufacturing facility, present data for review on routine basis, create EM Trend reports, assist with EM Excursion Investigation, and perform sample receipt and sendouts.
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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.
