Bioassay Development(Study Director)

Location: Pune

Position: Regular

Experience: 2-7 years

Job function: Scientific Initiatives

Role: Full time

Job Description

- Responsible for study plan design and getting approval, as well as overseeing data collection, analysis and reporting
- Ensure that the Quality Assurance personnel have a copy of the study plan and any amendments in a timely manner and communicate effectively with the Quality Assurance personnel as required during the conduct of the study
- Ensure that study plans and amendments and Standard Operating Procedures are available to study personnel
- Ensure that the study plan and the final report for a multi-site study identify and define the role of any Principal Investigator(s) and any test facilities and test sites involved in the conduct of the study;
- Ensure that the procedures specified in the study plan are followed, and assess and document the impact of any deviations from the study plan on the quality and integrity of the study, and take appropriate corrective action if necessary; acknowledge deviations from Standard Operating Procedures during the conduct of the study
- Ensure that all raw data generated are fully documented and recorded
- Ensure that computerized systems used in the study have been validated
- Responsible for preparation, revision, amendment and signing of the study report
- Sign and date the final report to indicate acceptance of responsibility for the validity of the data and to indicate the extent to which the study complies with GLP Principles
- Ensure that the study report has been reviewed and signed by the sponsor/ sponsor s representative
- Ensure that after completion (including termination) of the study, the study plan, the final report, raw data and supporting material are archived.
- Preparation / Review of SOPs, Protocols, logbooks, records, QMS.
- Conduct trainings.
- Co-ordinate with service engineer for equipment related concerns.
- Support in client related technical discussion and compliance requirements.




- Support in inventory management, procurement and qualification of equipments/ instruments and computerized systems.
- Performing risk assessments, gap analysis, root cause analysis during failures or incidents.

Qualifications Skills

- Ph.D. with 3-7 years of experience in biologics, bioassays, analytical characterization, and regulated laboratory environments.
- Experience in managing study support activities, method development, data review, compliance, and cross-functional coordination.
- Strong exposure to GLP, GDP, QMS, ALCOA++ principles, audit preparedness, computerized system validation, and regulatory compliance requirements.
- Experienced in preparation, review, and management of SOPs, protocols, validation reports, qualification documents, analytical reports, and regulatory responses.
- Hands-on experience in bioassays, ELISA, SPR platforms (Biacore systems), cell-based assays, characterization assays, and analytical method qualification/transfer.
- Demonstrated capability in study execution, deviation handling, technical troubleshooting, root cause analysis, and maintaining data integrity in regulated environments.
- Experienced in team handling, training, work delegation, inventory oversight, equipment coordination, and stakeholder communication.
- Prior exposure to drug discovery, cell culture, and molecular biology techniques during doctoral research.

Preferred / Nice-to-Have

- Prior experience working in a CRO, biopharma lab, or characterization services setting.
- Experience in biosimilar characterization, comparability studies, regulatory-compliant analytics.
- Familiarity with business development for lab services, cost-recovery models, client engagement, and service-oriented delivery.
- Publication record (for credibility); experience in cross-functional collaboration (with upstream process development, regulatory, formulation teams).

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Bioassay Development(Study Director) (Pune)
🏢 Venture Center
📍 Pune