QC Microbiology Manager

Overview:

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At EyePoint, leadership trusts our employees to get the job done. The patient-centric and award-winning approach we’re taking in business fuels our success for:

• preventing blindness through vision-saving medications
• delivering best-in-class proprietary pharmaceutical technologies
• transforming ocular drug delivery

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Your wellbeing

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Your future at EyePoint

EyePoint offers robust total rewards in a science-based entrepreneurial culture that empowers curiosity and innovation to help catapult your career. There’s space for every voice and perspective to be heard in our on-site and remote environments where a variety of strengths and diverse backgrounds are connected.

The individual will work at the QC Microbiology laboratory located in Northbridge, MA, and will oversee the Watertown, MA facility microbiology testing.

This person will report directly to the Associate Director of Quality Control and will be responsible for managing and organizing the Microbiology Group within Quality Control (QC). The manager is responsible for the day-to-day activities that occur in the microbiology group at the Northbridge and Watertown sites, assuring that all lab operations and testing are performed in compliance with all applicable regulation, specifications, procedures and policies as well as current industry practice (US and Europe). Those activities will include, but are not limited to:

• Micro Laboratory operations
• Management of lab personnel
• Product testing
• Management of Contract Test Laboratories (CTOs)
• Method verification and validations
• Management of the Environmental Monitoring Program. (EM) This individual will lead the efforts in the operationalization of a new Microbiology Lab in Northbridge MA, including, but not limited to:
• Internal microbiology program development
• Equipment purchasing and qualification
• SOP/ Test method / Work Instruction and Report authoring

Responsibilities:

Primary responsibilities include, but are not limited to, the following:

• Sample and monitor, if necessary, critical systems such as the purified water system and the clean compressed air system.
• Interact with external contract laboratories to support sample testing, data analysis and investigations as required.
• Collaborate with regulatory to support IND/NDA filings/amendments on CMC sections. Support regulatory PAI and cGMP audits and inspections. • Assist in authoring and reviewing standard operating procedures, test methods, and work instructions related to QC activities.
• Perform routine Laboratory housekeeping to ensure the maintenance and compliance of laboratory’s operational areas.
• Monitor quantitative and qualitative microbiological tests such as for media controls, enumeration, absence of index organisms, classification and speciation, antimicrobial effectiveness.
• Lead investigations in the following Quality Systems: OOS/OOT, Deviations, CAPA and Change Controls.
• Provide microbiological testing support for development protocols and reports as appropriate
• Trains and qualifies Microbiology Analyst on Aseptic Operations, Microbiological Sampling and Testing. • Tracks and reports Quality System Metrics relevant to testing, OOS Investigations, and training in support of Quality Systems Reporting to management.
• Functions as a technical advisor and problem solver for Microbiology related issues.
• Provides Support for Audits and Inspections.
• Participates in the Safety Program to evaluate microbiological aspects of safety.

Qualifications:

Primary skills and knowledge required include, but are not limited to the following:

• Knowledge of cGMPs and related compliance regulations and guidance is required (e.g. Title 21 CFR Parts 11, 210/211, 820,) USP/EP / ICH Guidelines.
• Previous supervisory experience in QC Microbiology laboratory. Demonstrated successful management of laboratory operations, Environmental monitoring, method validation, and equipment qualification.
• The individual must possess good leadership and communication skills.
• The individual is proficient in aseptic microbiological techniques and methodologies including membrane filtration methods, pour plate methods, gram stains, colony counting.
• Strong experience in developing Microbiological assays, (Bioburden, Endotoxin, Morphology, Gram Stain and Microbial Identification) and managing testing by compendial methods.
• Experience in antimicrobial effectiveness testing, sterility testing, method validation, cleanroom practices.
• The individual is a motivated person who possesses good interpersonal skills capable of effectively interacting with all departments and suppliers. Flexible and able to respond quickly to shifting priorities to meet deadlines.
• The individual must have good organizational technical documentation and computer skills. Ability to communicate and work independently with scientific/technical personnel in both internal and external setting.
• Routinely exercises sound judgment, reasoning and problem solving. Must be a team player with integrity and concern for the quality of Company products, services and staff members.
• Position may involve use of reagents and other chemical compounds that are considered hazardous
• Must be flexible in terms of working hours to meet the requirements of the position.

Level of Education Required:

• BS in Microbiology, Biology or related Science discipline is required.
• An MS in Microbiology, Biology or an equivalent combination of education, training and experience in the pharmaceutical or biopharmaceutical industry is preferred.

Number of Years of Experience in the Function and in the Industry:

• Minimum 2 years of supervisory experience
• Minimum 5 years of experience in a regulated Microbiology Lab
• A minimum of 5 years of demonstrated practical Quality Control experience in cGMP regulated laboratory.

Envision Your Future

With the exciting energy of a winning culture and an exhilarating pace, we are an ophthalmology company committed to preventing blindness by developing and commercializing innovative therapeutics.

• Success begins with our People
• Patients First
• Integrity
• Results-Driven
• Innovation
• Team Focus
• Diversity & Inclusion

All applicants will be considered for employment without attention to age, race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.

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