Senior Scientist, Downstream Process Development
- Posted: over a month ago
The role of Senior Scientist, Downstream Process Development is responsible for leading and conducting downstream process development activities in support of Ocugen’s preclinical and clinical pipelines to enable IND filings in accordance with agreed upon departmental priorities, taking into account scientific and timing objectives.
Duties and Responsibilities:
- Perform process development of the cell culture or purification process steps
- Primary responsibilities will include participating in the design of experiments, executing the planned experiments, and optimizing the process steps to the target process scale This will include laboratory and occasional pilot-scale scale work with bioreactors, chromatography systems and filtration
- Design, develop and execute processes for the recovery and purification of biological materials to optimize production and reduce variability in drug substance and drug product manufacturing, specifically relating to vaccine and gene therapeutic process development
- Design and execute development studies (DoE) in the in-house PD lab to identify and determine appropriate conditions and ranges of (critical) process parameters for chromatographic purification & separation and several types of filtrations (process optimization)
- Perform assays on gene therapeutic, biologics and/or vaccine products, process intermediates, and related experimental samples using biochemical/analytical tests
- Record and analyze experimental data, verify data integrity and accuracy, and report/summarize findings to the project team, and also draft technical documents and support technology transfer to collaboration partners following good manufacturing practices (GMP)
- Participate in routine meetings CRO/CMO to manage the downstream activities drafting and reviews of various documents such as study design, protocols, batch records, and reports.
- Expected to work in a team environment as well as contributing individually to meet project timeline(s)
- Prepare solutions/reagents. Set-up process equipment for lab-scale experiments
- Contribute to conducting a root cause analysis and assist in implementing proposed corrective actions regarding downstream process-oriented systems
- Contribute to downstream process development sections of CMC modules in regulatory documents including IND, NDA, BLA, MAA and other regulatory
- Contribute to process development team in the development of high-quality product and in-process methodology as per regulatory
- PhD in Chemistry, Biochemistry, or Analytical Science with 5+ years of pharmaceutical CMC industry experience and a demonstrated technical leadership in process development, vaccine and/or ophthalmology experience
- Proven ability to provide process expertise on programs/project teams for pre-clinical and clinical studies with a wide variety of techniques and technologies
- Experience working in a GMP regulated
- Strong scientific and operational background in the optimization and validation of downstream processing for harvesting, filtration, capture and purification methodology
- Strong understanding of method development, technical transfer, and GMP Experience with IND and/or BLA submissions
- Detail oriented, exceptional documentation practices, technical writing and verbal communication skills
- Excellent contingency planning and time management skills and demonstrated ability to manage several projects
- Possess strong problem solving and analytical skills and be an independent and creative
- Ability to navigate and be successful in a fast-paced, highly matrixed work
This job requires a person to work in laboratories and offices to conduct experiments, analyze the results, and create reports and scientific presentations. The employee will be spending 70% of work hours at the process development and research and development laboratory and is expected to work with biological materials, microorganisms, cells, and laboratory chemicals. They are expected to work with vendor, CROs, and CMOs in drafting and reviews of various documents such as study design, protocols, batch records, and reports. This position requires travel to CRO/CMO sites as needed.
Person may have to stand and sit for longer duration during experiments.
Ocugen is an equal opportunity employer. In order to provide equal employment and advancement opportunities to all individuals, we make all of our employment decisions based upon merit, qualifications, abilities, and an individual’s conduct and performance. We will not make any of our decisions, and will not discriminate against any employee or applicant, on the basis of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including sexual orientation, gender identity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, or any other characteristic protected from discrimination under the law. Ocugen complies with applicable federal, state and local laws governing nondiscrimination in employment.
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