EyePoint Pharmaceuticals, Inc. Director, Quality Control in Watertown, Massachusetts
We are an ophthalmology focused company committed to developing and commercializing innovative ophthalmic products in indications with high unmet medical need to improve the lives of patients with serious eye disorders
EyePoint Company Values include:
Success begins with our People – our employees are valued, relied upon and key to our company’s success
Patient First – above all, we dedicate our skills, actions & resources to achieve quality outcomes for our patients
Integrity– we are always honest, open, ethical and fair
Results-Driven– we are decisive and act with a sense of urgency against clear and aggressive goals
Innovation – we strive for continuous improvement through thoughtful risk-taking
Team Focus– we work and communicate in a collaborative, respectful and inclusive fashion
Diversity & Inclusion - We commit to diversity in our staff and embrace inclusion and acceptance of others without bias
Reporting directly to the VP, Quality, the Director, Quality will be responsible for managing the GMP QC laboratory to ensure that all products are tested for both analytical and microbiological assays, and test results are reviewed and approved for release in accordance with company’s procedures and applicable GMP regulations and guidelines (e.g. 21CFR Parts 11, 210/211, 820, (USP/EP/JP), ICH Guidelines, etc.).
This person will manage QC’s day-to-day activities which include all aspects of quality control to support release of clinical trial materials and commercial products, as required. This position will interact with cross-functional colleagues from Development, Operations, QA/QC, and Regulatory Affairs departments.
Develop QC personnel training plans,
Provide Good Laboratory Practices (GLP) and/or technical training to QC staff when required.
Ensure current good manufacturing practice (cGMP) including good documentation practice (GDP) are followed throughout laboratory operations.
Adhere to GMP Quality Management System (QMS) currently in place to ensure compliance with documented policies and procedures.
Manage the incoming inspection for raw materials and parts.
Manage the GMP laboratory to ensure the following tasks are performed by QC staff:
testing of raw materials and final products by following analytical methods.
performing sample management and incoming quality assurance (IQA) verification of raw materials, as required.
operating instruments for all analytical assays,
ensuring that the equipment are properly calibrated and maintained.
performing routine laboratory housekeeping to assure the maintenance and compliance of laboratory’s operational areas.
tracking and testing products according to Stability Program’s schedule and protocols.
managing the stability program.
generating CoAs for product release.
performing routine laboratory testing as needed.
Conduct investigations regarding out-of-trend (OOT)/out-of-specification (OOS) results, or Environmental Alert/Action Report (EAR).
addressing and managing deviations related to analytical/microbiological procedures.
providing update of OOT/OOS/EAR/Deviation to management.
applying SOPs, WIs, Specifications, Trends, and technical expertise to troubleshoot and resolve laboratory issues.
Draft, revise and review SOPs, Specifications, Qualification/Validation protocols and reports, as appropriate.
Work with internal and external resources to maintain laboratory in an optimal and compliant state, (e.g. coordinate with internal stakeholders to support operational activities, or coordinate with external vendors to support calibration/preventive maintenance activities, etc.)
Plan and perform workload to meet schedules, timelines, deadlines as per procedure’s and/or department requirements.
Lead or participate in project team for project and process improvement initiatives including method transfer and test lab selection.
Monitor and trend data, complete routine record review of test data and related documents for incoming, in-process testing, drug substance and drug product release as well as environmental monitoring.
Identify gaps in systems and procedures. Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate.
Assist in the preparation of regulatory submissions and QC data packages for interactions between EyePoint Pharma and Regulatory agencies, when required.
Support internal and external audits and regulatory inspections, as required.
Participate as Subject Matter Expert (SME) during Regulatory Inspections, as appropriate.
Perform other duties as assigned by Quality Management to support Quality activities.
MS or PhD degree in a chemistry or biochemistry discipline.
7–10 years of demonstrated practical Quality Control experience in GMP regulated laboratory in pharmaceutical or biopharmaceutical industry
3-5 years of experience managing a GMP laboratory
Hands-on experience with High Performance Liquid Chromatography (HPLC) and Spectroscopy Required.
Working knowledge of Environmental Monitoring (EM) and other microbiological assays such as: endotoxin, bioburden, sterility, etc.
Self-motivated, strong work ethic, strong organizational skills, strong communication skills, critical thinking, attention to detail and accuracy, the ability to work independently and in a team environment, are essential.
Strong verbal and written skills.
Working knowledge of GLP documentation and application of principles, theories and practices of the analytical chemistry and/or microbiological, is required.
Routinely exercises sound judgment, reasoning and problem solving.
Capable of timely completion of assigned responsibilities under minimal supervision.
Flexible and able to respond quickly to shifting priorities and meet deadlines.
Position may involve use of reagents and other chemical compounds that are considered hazardous.
Proficiency with Microsoft Office tools (Excel, Word, PowerPoint, Outlook).
Ability to work and interact with all departments at EyePoint Pharma.
Ability to communicate and work independently with scientific/technical personnel in both internal and external setting.
External Company Name: EyePoint Pharmaceuticals, Inc.
External Company URL: http://eyepointpharma.com/
Street: 480 Pleasant Street