Analytical Scientist
Ocugen Opco Inc
Malvern, PA (In Person)
Full-Time
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Job Description
Position Summary We are seeking a motivated Analytical Scientist to support analytical development for AAV gene therapy programs, with a primary focus on chromatography and analytical chemistry methods. This role will support development, optimization, and execution of chromatographic assays used for AAV vector characterization, impurity analysis, and process development support. The ideal candidate will have 2-3 years of industry experience working with AAV gene therapy products and hands-on experience with HPLC/UPLC-based analytical methods. Responsibilities Develop, optimize, and execute chromatographic methods (HPLC/UPLC) for AAV product characterization. Support analytical methods used for purity, identity, and impurity profiling of AAV vectors. Perform method optimization, troubleshooting, and robustness assessments. Conduct analytical testing using techniques such as HPLC, UPLC, SEC, IEX, and RP chromatography. Support characterization of AAV capsids, aggregates, and process-related impurities. Generate high-quality analytical data to support process development, comparability, and stability studies. Support analytical method qualification and transfer to QC laboratories. Assist in preparing analytical protocols, reports, and technical documentation. Analyze chromatographic data and summarize results in technical reports. Maintain laboratory documentation in accordance with GxP and data integrity (ALCOA+) standards. Provide analytical insights to support process and product development. Education MS or BS in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or related field. Experience 2-3 years of industry experience in AAV gene therapy or viral vector analytical development. Technical Expertise Hands-on experience with chromatographic techniques (HPLC/UPLC). Experience with SEC, IEX, or reverse-phase chromatography. Experience with chromatography data systems (e.g., Empower or OpenLab). Strong understanding of analytical chemistry principles and assay troubleshooting. Strong analytical thinking and problem-solving skills. Ability to work effectively in a collaborative, fast-paced R&D environment. Preferred Qualifications Experience supporting AAV vector characterization. Familiarity with method qualification or validation in a regulated environment. Experience supporting CMC development programs for gene therapy products. Working Conditions This position operates in an office setting, in person. Job may additionally require incumbent to be available outside of these hours to handle priority business needs. Physical Requirements This is a mostly sedentary role. 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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