SUJATA BHAVEKAR

• Oversee SOP Finalization: Ensure all necessary SOPs are completed and finalized by the set deadline.
• Project Plan Approval: Review and approve the Project Plan and any amendments, ensuring compliance with regulatory and quality standards.
• Single Point of Control: Act as the single point of control for the study, maintaining the quality, integrity, and technical conduct.
• Training and Compliance: Ensure all staff understand study requirements and provide specific study-based training if needed. Verify that all training is documented.
• Pre-Study Activities: Obtain and review the current study protocol, establish communication with the sponsor, and ensure all necessary materials and reagents are received and characterized.
• Conduct of Study Activities: Schedule resources, conduct necessary meetings, ensure compliance with the Project Plan and SOPs, and monitor the study's progress and data integrity. Address and document any deviations or significant changes.
• Post-Study Activities: Signify study completion, notify relevant parties, complete a study review form, and ensure all records are verified, approved, and archived. Obtain instructions for the disposition of test materials as needed.
• Communication: Maintain clear and effective communication with the team, sponsor, and other stakeholders, ensuring all correspondence is documented.

Responsibilities:

• Scientific Leadership: Led and directed scientific work to support over 30 external projects and methods, providing expert guidance to a multidisciplinary team of 15 scientists.
• Quality Management: Developed robust quality systems, ensuring compliance and alignment with corporate goals.
• Regulatory Compliance: Proficient in method development and method validation, adhering to regulatory guidelines including M10 Guidelines, USP 1224, 1225, 1226, ICH Q2, Q7, Q14, and 21 CFR 211, 212. Furthermore, leading regulatory inspections, driving adherence to GXP regulations and industry standards.
• Partnership & Improvement: Fostered collaboration with stakeholders and drove continuous process improvement.
• Protocol Development and innovation strategy development: Developed, drafted and reviewed 200+ protocols and 300+ sample analysis plans to ensure they were well-designed, scientifically sound, and in compliance with industry standards.Developed and implemented comprehensive stage-gated innovation strategies aligned with company growth objectives and market trends, fostering a culture of creativity and forward-thinking within the scientific team.
• Method Validation: Collaborated closely with the method development team to review and approve 50+ methods, ensuring they were thoroughly validated and ready for use in clinical studies.
• Data Review: Independently reviewed and approved raw data for over 50+ studies, meticulously evaluating data and tables to ensure they consistently met or exceeded regulatory guidelines and expectations.
• Report Approval: Took responsibility for reviewing and approving reports for 150+ studies, consistently verifying the scientific accuracy and completeness of both clinical and non-clinical research projects.
• Technical Expertise: Provided technical expertise and guidance, successfully resolving assay-related issues in 95% of cases, minimizing delays and ensuring project continuity.
• Scientific Investigations: Actively participated in 200+ scientific investigations and approved quality assurance reports specific to project inspections, contributing to effective issue resolution.Collaborated with the R&D team, scientific experts, and researchers to support the development of scientifically backed and efficacious bioanalytical methods
• Client Interaction: Served as the primary scientific point of contact for 30+ clients, collaborating closely with them to determine project requirements and provide expert scientific directives.Study Team Support: Offered invaluable guidance to the study team, promptly identifying and addressing scientific issues and scope changes within the study, leading to a 10% reduction in project delays.
• Communication: Ensured seamless communication and consistently met scientific expectations among 50+ scientific staff and clients, fostering a culture of quality within the study team.
• Team Management: Effectively managed and directed teams, including Clients, Scientists, QA, and QC teams, to meet client specifications and consistently maintain a high level of quality in project deliverables.
• Project Management: Successfully executed, planned, prioritized, and managed workloads for over 30 large and complex projects, ensuring they were completed successfully and on time, with a 98% project completion rate.
• Bioanalytical Expertise: Managed a scientific team proficient in performing bioanalytical assays for various therapeutics, resulting in consistently accurate and reliable results for clients.
• Market Analysis: Conducted competitive market analysis to identify gaps, trends, and opportunities for innovation in bioanalytical methods, translating insights into actionable plans for method development.

• Responsibilities:
• Scientific Leadership: Led and directed scientific work for 20 to 50 junior scientists, overseeing external methods and projects while maintaining strict adherence to regulatory standards.
• Project Management: Successfully managed and completed 15 clinical studies at a time and on time, within budget, and in compliance with FDA/ICH and other regulatory guidelines.
• Manufacturing Expertise: Executed and oversaw the manufacturing of 100-200 large molecules, peptides, and oligonucleotides routinely, optimizing processes to increase product yield by 15%.
• Cross-Functional Collaboration: Actively mentored, trained, and collaborated with cross-functional teams, resulting in a 10% improvement in overall organizational turnover and efficiency.
• Laboratory Proficiency: Contributed to purifying 10 to 15 peptides per day and conducted more than 100 peptide synthesis, and performed 100 ligand binding assays, ensuring the reliability of data using instruments such as LC-MS, HPLC, and UPLC.
• Statistical Analysis: Applied advanced statistical methods to analyze experimental data, resulting in a 20% reduction in experimental errors and improved data reliability.
• Quality Assurance : Conducted rigorous quality assessments and addressing QAIR reports biweekly for more than 200 to 400 peptides ensuring a 98% quality compliance rate.
• Process Optimization: Innovatively optimized manufacturing processes, leading to a 25% increase in product yield and productivity while maintaining stringent regulatory compliance.
• Quality Management System: Implement a robust risk-based quality management system, resulting in a 30% reduction in non-compliance incidents and ensuring sustained adherence to international standards.
• Manage Third-Party Providers: Develop and implement processes for third-party providers, resulting in a 15% improvement in supplier quality performance and adherence to quality expectations.
• Implement Quality Systems: Successfully implement and maintain quality systems, leading to a 20% reduction in processing time for lot release, training, and change control activities.
• Provide Expertise: Offer expert guidance to internal departments, resulting in a 40% decrease in deviations and ensuring all activities meet GXP compliance requirements.
• Host Regulatory Inspections: Effectively host regulatory inspections, achieving a 90% success rate in responding to findings and maintaining compliance with regulatory standards.
• Diagnostic skills : Skillfully prepared more than 500 sets of 96 well plates and diagnostic data using HPLC and Mass Spectrometry (MALDI-TOF) for research studies, including immunoassay and endotoxin testing of peptides.
• Bioanalytical Expertise: Developed, conducted, and managed many bioanalytical assays, including interference testing.
• Innovation Strategy Development: Contributed to the development of innovation strategies aligned with company objectives, optimizing resources to achieve project goals and timelines effectively.

• Built and strengthened positive relationships with students, parents and teaching staff.
• Managed student behavior in classroom by establishing and enforcing rules and procedures.
• Instructed students and supported understanding of math concepts.
• Taught various kinds of math at standard, remedial and advanced levels.
• Adapted teaching methods and instructional strategies to promote learning in students of differing skill levels.

Responsibilities:

• Scientific Leadership:
• Led and directed scientific work to support 20 external clinical research methods and projects, ensuring strict adherence to industry standards.
• Pharmaceutical Analysis: Conducted comprehensive analysis of over 100 pharmaceutical finished products, utilizing various methods to assess purity, stability, and efficiency. Communicated analysis results effectively to relevant departments and stakeholders, facilitating product formulation and evaluation, achieving a 99% data accuracy rate.
• Study Oversight: Conducted 30+ pre-study, closeout, and interim site visits, meticulously monitoring and maintaining compliance with clinical study activities.
• Participant Eligibility and Consent: Assessed proof of eligibility and consent for 500+ study participants, upholding ethical and regulatory requirements with a 100% compliance rate.
• Regulatory Compliance: Actively participated in regulatory activities and submissions, aligning with independent ethics committee and regulatory board standards for 15 clinical trials.
• Study Management: Managed end-to-end aspects of 10 assigned clinical studies, ensuring all were completed on time, within budget, and in full compliance with FDA/ICH and regulatory guidelines.
• Collaboration and Communication: Played a pivotal role in 10-15 Investigator meetings, coordinated CRA teams, and provided valuable assistance for 25+ study-related inquiries.Drafted protocols, analytical plans, reports, and other study-related documentation for 8 clinical trials, consistently following SOPs and guidelines.
• Quality Assurance: Evaluated drug storage conditions and procedures for 50+ clinical sites, maintaining strict adherence to established protocols.
• Adherence to Clinical Practices: Demonstrated unwavering commitment to good clinical practices, standard operating procedures, and regulatory requirements across all assigned studies.
• Stakeholder Collaboration: Collaborated effectively with 10 sponsors and 15 investigators to orchestrate efficient and fully compliant research trials.
• Data Management: Systematically organized, analyzed, and modeled data from 15 clinical trials to drive informed decision-making and ensure data integrity.
• Documentation Excellence: Maintained meticulous records of all clinical work, including 100% accurate and timely submission of clinical documentation in strict accordance with agency guidelines

Responsibilities:

• Pharmaceutical Analysis: Conducted rigorous laboratory analysis of over 500+ pharmaceutical finished products using a diverse range of analytical methods to assess purity, stability, and efficiency. Achieved a consistent data accuracy rate of 98% through meticulous lab work and precise documentation.
• Quality Control Analysis: Performed comprehensive quality control analysis of 200+ various drug formulations in solid dosage forms using various methods and techniques, ensuring product quality and compliance.
• Method Development and Validation: Developed, optimized, and validated 20+ analytical methods for the characterization and quantification of active phaexcipientsl ingredients (APIs) and excipients in injectable and solid dosage forms.
• Laboratory Management: Effectively facilitated workflow and schedules of lab teams, ensuring quality and compliance of drug products in both preclinical and clinical phases. Supported objectives, checkpoints, and timelines while managing team members to meet project tasks and expectations.
• Stability Studies: Led key roles in stability studies for 5 product lines, conducting extensive laboratory work to determine the shelf-life and storage conditions of injectable products.
• Manufacturing Optimization: Collaborated closely with formulation scientists and manufacturing teams, conducting hands-on laboratory work to troubleshoot technical issues. Optimized the manufacturing process of injectable dosage forms, resulting in a 5% reduction in batch failures.
• Problem Solving: Led or supported troubleshooting of 10+ laboratory operational issues, applying hands-on problem-solving skills to reduce project bottlenecks or delays.
• Documentation: Performed laboratory research, adhering to all guidelines and regulations to ensure safety and protective procedures were followed.
• Bioanalytical Methods: Developebioanalytical and conducted 25+ bioanalytical methods and processes within the laboratory setting in support of drug discovery efforts