Ocular Therapeutix→
Manufacturing Engineer I at Ocular Therapeutix in Bedford, MA
Skills
Job Description
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:
We are seeking a motivated Engineer to join the MSAT team as a Manufacturing Engineer I. The individual will join a team in the clinical and commercial development of the processes used to manufacture a sustained release implant for use in the treatment of retinal diseases. The role includes but is not limited to experimental design, process development, product design, characterization, and GMP manufacturing of clinical stage products. This individual will assist in execution of assigned project activities and work with project team members to improve, evaluate, and manufacture the drug product. The position is set in a dynamic and fast-paced environment.
Critical areas of focus will be in laboratory work and experimental design for technical transfers and scale-up development. Incorporation of automation into a complex manual process will be another area of focus for this engineer.
Principal Duties and Responsibilities include the following:
- Assist in the design and development, using sound engineering problem-solving techniques, of product and process development studies.
- Assist in the execution and characterization of product and process development studies.
- Assist in the development of scalable commercial manufacturing processes, meeting all critical quality attributes, using a QbD approach.
- Assist in the improvement of current clinical and commercial manufacturing activities.
- Assist in the implementation of automated systems.
- Assist in the cGMP manufacturing of drug product batches in clean room environment to support clinical studies.
- Develop understanding of GMP regulation and FDA/EMEA guidance on manufacturing process and apply them during manufacturing of drug product/device batches.
- Analyze and evaluate the impact of process and product variables on drug product characteristics.
- Communicate study designs, data analysis and conclusions to project team members.
- Generate technical documents including protocols and reports summarizing experimental plans and test results.
- Generate GMP documentation including Standard Operating Procedures, Work Instructions, Batch Records, Technical Documents, Material Specifications, etc.
- Collaborate effectively with MSAT group and project team members.
Qualifications:
- BS in Biomedical Engineering, Chemical Engineering, Mechanical Engineering or related discipline. Advanced degree (MS/PhD) desirable.
- 0-3 years of industry experience in drug product or process development or manufacturing.
- Strong understanding of engineering principles, methods and procedures.
- Demonstrated ability to apply strong fundamental scientific and engineering skills to evaluation of processes and development of practical solutions to technical challenges.
- Good interpersonal, communication, data analysis and effective problem-solving skills.
- High degree of initiative and self-motivation.
- A diligent team-player that is passionate about helping patients and effectively collaborates in a dynamic, cross-functional environment.
- Experience with generic lab equipment (Ex. pipettes, balances, pumps, microscopes) is preferred.
- Experience with GMP in pharmaceutical manufacturing is preferred.
- Experience with tech transfer of development manufacturing processes to commercial scale is preferred.
- Experience with statistical software such as JMP, Minitab, or similar to report data is preferred.
- Experience with CAD software such as SolidWorks, AutoCAD, or similar is preferred.
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.