Bioassay Development(Study Director)

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 environment.

• 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).

General requirements and expectations from Venture Center employees:

• Venture Center is a non‐profit organization with aim to benefit society by promoting entrepreneurs and start‐ups. Thus, Venture Center seeks employees and consultants with a strong interest and passion in seeing technology innovators, entrepreneurs, and start‐ups succeed, and a strong "service" ethos.
• A strong feature of Venture Center jobs is the rich learning environment and opportunity provided to employees to experiment, take initiative and be creative. The work of most employees has visible impact which can be satisfying. All employees benefit from access to high quality facilities and work environments. Compensation packages can be flexible but are often conservative due to Venture Center’s non‐profit status.
• General requirements include: a) strong ethical standards and work ethics, b) comfort with computers, computer applications and internet, c) strong communication skills – spoken and written.
• Venture Center’s working hours are 9.30 AM – 5.30 PM (Monday to Saturday) and are designed to keep operations of Venture Center convenient for the start‐ups, entrepreneurs, inventors and others that the organization serves. Managers in certain functions are provided the opportunity to avail of flexible hours. All jobs are located at Pune, Maharashtra, India
• Our Company is an equal-opportunity employer and does not discriminate against any employee or applicant based on age, color, disability, gender, national origin, race, religion, sexual orientation or parental status.