Supervisor, Manufacturing
$80k - $85k USD
Ocular Therapeutix, Inc. (NASDAQ:OCUL) is a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology, ELUTYX™. Ocular Therapeutix has built a robust product pipeline of drug delivery solutions developed to reduce the complexity and burden of the current standard of care and position itself to become a leader in the ophthalmic space.
Outside of the ophthalmic realm and behind the doors of our headquarters in Bedford, MA, we strive to build a strong culture where employees can flourish and achieve their career goals. We encourage out of the box thinking, cross-functional collaboration, and creativity.
Position Summary:
The Supervisor, Manufacturing is responsible for performing and assisting with all processes related to the manufacture of Ocular Therapeutix products. This includes the routine execution of clinical trial builds, commercial production builds and integration of new processes within the current pipeline.
Principal Duties an Responsibilities:
- Lead and supervise daily manufacturing activities by scheduling tasks and roles for operators to efficiently complete manufacturing.
- Supervise manufacturing operator direct reports while addressing any concerns of team members and providing conflict resolution as necessary.
- Provide feedback throughout the year to direct reports and conduct routine performance reviews.
- Apply cGMP and cGDP guidelines to all activities.
- Perform various manufacturing processes by following documented SOP’s and procedures, calculating requirements, weighing materials, and operating various equipment. Processes include but are not limited to formulation, inspection, in-process packaging and finished product packaging.
- Complete documentation (batch records, process routers, forms, etc.) and review of executed documentation as required throughout the manufacturing process.
- Troubleshoot issues as they arise related to equipment and/or manufacturing processes.
- Own and complete deviations and CAPAs related to the manufacturing process. Properly identify deviations and accurately document the events. Work cross functionally to arrive at corrective actions and implement the identified action.
- Proactively identify and implement process improvements related to a continuous effort to improve culture, repeatability, execution and compliance. Navigate within the existing quality process to properly deliver the identified improvement.
- Train operators on new processes and ensure operators are properly trained for the task or role.
- Learn multiple product manufacturing operations and assist in the transfer of the process between manufacturing and process development. Identify issues and solve problems relating to the implementation of a repeatable manufacturing operation.
- Assist in new process integration into the manufacturing group.
- Perform other duties as required.
Qualifications:
- Associate’s degree is required, bachelor’s degree in a science field or equivalent preferred
- 2-4 years of prior experience in the pharmaceutical industry is required
- GMP clean room experience is required as well as knowledge of FDA regulations, cGMP and cGDP’s
- Chemical handling and solution preparation experience preferred
- Ability to evaluate manufacturing schedule and appropriately assign operators and roles
- Basic computer knowledge, such as Microsoft Word, Outlook and Excel is required
- Must have very good written and oral communication skills as well as willingness to learn
- Ability to interact with all Manufacturing Managers, Manufacturing Engineers, Quality Control, Research & Development and other personnel
- Excellent organizational skills and attention to detail with the ability to multitask
- Ability to work in environmentally controlled areas (ECA) or lab environment
Working Conditions:
- Ability to gown and gain entry to pharmaceutical manufacturing areas; ability to wear personal protective equipment such as safety glasses/goggles, gloves, and safety shoes
- Ability to lift, pull or push equipment requiring up to 25-50 lbs.; ability to stand for 6 hours in a production suite
- Ability to climb ladders and work platforms
- Ability to work flexible hours to complete work activities
- Ability to work around chemicals (alcohols, acids & bases
Salary Range
$80,000—$85,000 USD
Ocular Therapeutix is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws regarding nondiscrimination. Ocular Therapeutix provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, or status as a veteran. For information on how Ocular Therapeutix collects, stores, and utilizes candidate information please see our privacy policy found at https://www.ocutx.com/privacy-policy/. For the Privacy Notice for California Job Applicants, please see CCPA Applicant Notice.