3 Director, Bioanalysis, and Immunoassay Development Jobs in Malvern, PA
OCUGEN OPCO INC is Hiring a Director, Bioanalysis, and Immunoassay Development Near Malvern, PA
Job Details
Description
Job purpose
The role of Director, Bioanalysis, and Immunoassay Development, is responsible for leading and working on bioanalytical activities related to preclinical and clinical research at Ocugen. This role requires development, planning, implementation, and maintenance of the bioanalytical development, qualification, validation, data analyses , report preparation, and regulatory writings related preclinical and clinical development activities of Ocugen’s product pipelines. This will be a critical role in analysis for
Ocugen’s vaccine and biologics and gene therapeutic portfolios. This position reports directly to the Chief Scientific
Duties and responsibilities
- Develop bioanalytical development, qualification, and validation plan and timelines to support preclinical through clinical studies for Ocugen’s product portfolio
- Build, lead, expand and retain a strong Biologics team to support the growth and expansion of Ocugen
- Establish immunological methods (ELISA, LBA, ELISPOT, Cell based assays; and ADA), data analyses and reporting work flow at Ocugen as per GLP and GxP requirements
- Strong background of molecular and immunological assays
- Manage research team developing analytical methods for preclinical and clinical samples
- Work with vendors/CRO to support preclinical and clinical projects
- Collaborate with internal cross-functional team members and external CROs to support method transfer and validation as per the global regulatory guidelines
- Oversee the evaluation of test results for accuracy and quality
- Work with R&D, clinical and regulatory teams in authoring sections related to preclinical and clinical studies for regulatory submissions
- Develop maintenance and troubleshooting protocols for instruments and equipment
- Ensure compliance with regulatory agency documentation and reporting requirements
Qualifications
- Mater/PhD in Biochemistry, Biology, Virology, or Molecular Biology with 8 years of experience in the biopharmaceutical industry
- Extensive experience in immunoassays (neutralization, serology, cell-based immune responses and ADA), molecular assays, and biochemical methods
- Experience or skills within project management
- Knowledge of applicable regulatory guidelines
- Experience working in a GMP regulated environment
- Strong collaboration and influencing skills. Motivated self-starter with a passion for patients.
Working conditions
This job requires a person to work in laboratories and offices to conduct experiments, analyze the results, and create reports and scientific presentations related to bioanalytical assays. Person will be spending 60% of work hours at theresearch and development laboratory and is expected to work with biological materials, microorganisms, cells, and laboratory chemicals. He/She is expected to work with vendor, CROs, and CMOs in drafting and reviews of various documents such as study design, protocols, batch records, and reports. Employee is expected to be available during non- work hours when needed to support Ocugen’s pipeline.
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.
Job Summary
Other
$170k-219k (estimate)
05/14/2024
07/13/2024
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