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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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The Manufacturing Engineering - Process Engineer will ensure that Quality Events (investigations, deviations, change controls, etc.) are completed in a timely manner by working with cross-functional teams to resolve issues for the Technical Operations organization. Will also participate in cross-functional teams on new processes including development, implementation, lifecycle management and continuous improvement activities including cost improvement initiatives and operational reliability
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Temporary member of Clinical Data Management team leading the activities associated with database rescue.
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Senior member of Clinical Data Management team leading the data management effort for multiple studies. Main responsibilities include protocol review, CRF design, generating data management documentation, conducting study specific data management training, and data quality checks on multiple studies.
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Member of Clinical data management team responsible for database development using multiple Clinical Data Management Systems on multiple studies. Primary tasks include development of CRF page layouts, database tables setup, edit check programming, database testing for release, edit check testing and data reports setup within targeted timelines. Support the on-going needs for data imports/loads and exports. Responsibilities also include post-production changes to the database as required.
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Validation is looking for a Computer System Validation (CSV) contractor for at least six months of full-time support to help us with CSV work. Specific projects/tasks identified as of now include the following:
- Write Configuration Specification/ Function specification for existing systems (Lyophilizer, Instron, Pico Jet, RO/DI, Continuous Process Improvement (CPV), Vaisala, etc.)
- Continue supporting validation activities for QAD and Verify Brand
- Perform Gap Assessment for the existing computerized systems
- Write test scripts for validating software functionality based on the gap assessment
- Develop the CSV program for Ocular Therapeutix
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Ocular Therapeutix is seeking a Senior Accountant who is primarily responsible for assisting in the month-end closing process, audit support and preparation, inventory management and any additional projects as assigned. Reporting to the Director, Accounting and External Reporting, there will be a myriad of l projects that this position will be an integral part.
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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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Provide strategic and tactical project management for CMC activities related to the Company’s early and late stage development programs. Work collaboratively with the involved functions and project teams to manage and integrate the CMC activities required at the various product development stages. The successful candidate will be a confident leader, with attention to detail and the ability to drive progress within the project team.
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Ocular Therapeutix is seeking an Information Technology Service Manager with experience in managing and delivering technical and logistical end user support to a diverse and growing environment. Success in this critical and forward-facing position means supporting all aspects of the IT Service Desk, including onsite, remote, and field-based support. The successful candidate must be able to create, scale, and streamline service processes, meet SLAs, and drive continuous improvement. In addition to having a solid technical background, this candidate must have strong communication and organizational skills, be able to work with an outsourced Helpdesk department, and have a passion for service.
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The Administrative Assistant/Marketing Specialist will be involved in all facets of the commercial team initiatives acting in a supportive and heavily administrative role. This role requires the successful management of multiple projects and should enjoy being part of and providing support to a dynamic team. In addition to the administrative nature of this position, the role also offers a great opportunity to obtain some hands-on marketing experience. Reporting to the Corporate and Marketing Communications Manager, there will be a myriad of special projects that this position will be an integral part of.
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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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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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The Calibration Maintenance Technician will be responsible for supporting the Manufacturing and Operations Department in various activities including, Facilities and Operations of the manufacturing areas. They will also be responsible for maintenance, testing, troubleshooting, calibration and repair of instrumentation for laboratory and manufacturing equipment.
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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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The Manager, Analytical Development will be responsible for the Management day-to-day activities of an Analytical Development team comprised of one or more analytical chemists. The team’s focus is the development and validation of analytical test methods suitable for analysis of clinical-stage drug product. The incumbent will be expected to oversee method development and validation activities to support small-molecule drug substance or drug product testing which meets phase-appropriate requirements. The incumbent is expected to maintain a laboratory presence and may represent Analytical Development in cross-functional project and CMC teams. Preference will be given to candidates with strong method validation and tech transfer experience.
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The Analytical Chemist II will be responsible for participating in the development and qualification of phase-appropriate analytical test methods to support clinical development of our drug product portfolio. The incumbent will develop and write methods, standard operating procedures, method qualification/validation protocols and reports, as well as engage in trouble-shooting and conducting continuous improvement on existing methods.
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Act as a senior team member of the Quality Control department to support technology transfer, deviation support, and investigations. Subject Matter Expert for more than one discipline. Technical writer of test methods, protocols, and reports as well as contributor to Annual Product Reviews and other Regulatory documents. Direct contact with customers and project teams. Acts as advisor to junior staff to meet schedules and/or resolve technical problems. Provides guidance to junior staff to achieve goals in accordance with established policies. Troubleshoot assay and instrumentation issues involving data mining, trending and analysis to identify problems.
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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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The Manager/Sr. Manager Clinical Supply Chain will be responsible for the planning, development, and execution of clinical supply chain activities, manage events of supply partners and is instrumental in timely planning, accurate forecasting and managing investigational supplies for all phases of clinical trials. They will be working closely and collaborate with Clinical Operations, Quality Assurance and Regulatory Affairs. They will be responsible for day-to-day activities related to managing the supply of Investigational Product (IP) through all stages of clinical development including packaging, labeling and distribution as well as, supporting and advising Clinical Operations, and clinical sites on all aspects of IP as applicable. The successful candidate needs to demonstrate end-to-end clinical supply chain knowledge and performance managing all aspects of clinical supplies in a global trial setting.
