SHIVANI GOEL

• Quality Control Senior Manager of Analytical supports day-to-day quality operations within Quality Control group via oversight of all elements of analytical testing
• This includes but is not limited to in-process testing, lot release testing, raw material testing, and stability testing. Managed over 40 manufactured lots with 20 various testing (which included HPLC, PCR compendial testing, etc.) in order to increase sales.
• Management of quality system elements such as deviations, corrective and preventive actions (CAPAs), investigations, Out of Specifications (OOS), change controls, data integrity, and training in support of Quality Control
• Supports cGMP Quality Control operations through administration of Quality Management Systems including, but not limited to, change controls, deviations, Out of Specification, Out of Tolerance and Corrective and preventive action (CAPA).
• Authors risk assessment as required to support QC Operations.
• Develop, implement, maintain and continually assess quality control function and quality management system for applicable regulated activities to meet internal company standards and external regulatory and customer requirements
• Maintain safe, efficient, functional and compliant laboratory according to regulatory, site and corporate guidelines
• Manage method Qualification/validation activities for drug substances, intermediates and finished drug products
• Perform clinical material evaluation and CoA generation.
• Manage method transfer activities to contract manufacturing organizations/testing laboratories.
• Write/review/approve, methods, protocols, validation reports.
• Establishing and maintaining document control system for QC procedures, work instructions and forms.
• Contribute to Annual Reviews
• Plan and coordinate all quality control activities and oversee day to day operation of QC Analytical laboratory
• Provide effective leadership to manage staff to achieve objectives and maintain daily operations
• Ensure staff are trained and professional development is encouraged
• Ensure compliance to national and international regulations and pharmacopoeia and make continuous improvements accordingly
• Support strong interactions and partnerships with cross functional teams
• Maintenance of critical reagents, controls, and laboratory supplies
• Support method validation and analytical technology transfer activities
• Supports internal and external audits as required including drafting audit responses in coordination with department management and subject matter experts.
• Represent Quality Control on project teams and in meetings as required.
• Reduced costs, optimized resource allocation, and improved efficiency in managing projects.
• Provided strong leadership to enhance team productivity and morale.
• Implemented and developed operational standards, policies and procedures.
• Improved team performance by providing comprehensive training and fostering collaborative work environment.
• Achieved operational excellence by streamlining processes and implementing best practices.
• Held weekly meetings to create plans to drive successful lot release.
• Mentored junior staff members for skill development and career progression within organization
• Conducted performance evaluations, compensations and hiring to maintain appropriate staffing requirements

• Oversee team of 10+ QC Analysts through effective planning, mentoring, directing and coordination of development activity
• Oversee supervisors that perform scheduling and performance of laboratory tests in manner such that results are accurate, precise, and reproducible
• Responsible for maintaining integrity of work areas including maintenance and calibration of equipment, general work center safety and cleanliness in compliance with established Quality standards
• Lead and facilitate initial and periodic training of QC Analysts to ensure standard laboratory practices, techniques, and adherence to cGxP and other applicable regulations and standards
• Communicate and enforce laboratory quality requirements to all personnel working in lab and ensure completion per GMP, GLP standards.
• Prepare and perform personnel evaluations and competencies and administer performance reviews
• Ensure timely and effective communication and escalation process exist to raise quality issues to appropriate levels of management
• Lead Out of Specification and trend violation investigations related to assay performance and procedural or analytical deviations or errors in laboratory and ensure corrective actions are developed and implemented
• Create, verify, and sign-off on COAs upon successful finished goods testing
• Participate in documentation and other process improvements, investigations and resolutions of product/process issues and general continuous improvement activities
• Participate in daily stand-up meetings (Tier Board)
• Responsible for operation of Chemical Laboratories to assure timely time completion and results reporting to meet production schedules
• Also manages stability test program
• Review and approve SOP/protocols and reports such as method validation, method transfer, and process/assay validation
• Manage Quality Control laboratories and staff to ensure lab testing that is compliant with SOPs, cGMP, Safety regulations & applicable FDA USP compendial methods
• Manages supplies and equipment calibration/PM schedule to ensure testing is executed in timely manner
• Works independently of direct supervision; Assumes responsibilities for daily functional activities and has authority to approve documentation and make decisions for facility’s QC department
• Participates in Regulatory/FDA inspections
• Ensures laboratory is prepared for inspections and manages any corrective actions necessary
• Manages administration of Quality Control Organization
• Administers budget and plans for future resource needs with regard to personnel, equipment, and facility
• Ensure appropriate staff appointment and training
• Manages staff performance and address issues in timely and sensitive manner
• Develops employees to better accomplish and perform in their duties as QC professionals
• Assumes QC responsibilities for major projects, such as new products or lab renovations
• Projects related to computer system control of laboratories
• Actively participates in and supports Continuous Improvement initiatives
• Maintain updated knowledge of QC and GMP trends
• Implement improvement projects to drive increased flexibility and reduce costs.

Coordinate with Operations, Supply Chain, QA to meet project timelines and timely release of commercial products to meet hospital demand

• Responsible for management of commercial stability program
• Design stability protocols
• Design specifications based on USP and stability results
• Review and approve Test Methods, stability protocols, amendments used for release testing and stability testing (Assay, Impurities, pH, color, clarity and HIAC)
• Reduced overtime levels while also improving turnaround time
• Responsible for reducing backlog in laboratory testing by greater efficiency and streamlining resources
• Responsible of ensuring that team members are properly trained
• Investigate non-conformities for out of specification (OOS), out of trend (OOT) results and invalid results
• Document discrepancies for stability, invalid and OOS for release testing in Kabitrack
• Initiate and complete Track Wise (TW) investigations for laboratory investigations and Corrective Action/Preventive Action (CAPA) and change controls
• Review and approve Track Wise investigations completed by QC chemists for OOS, invalid and OOT results
• Reduced overtime levels while also improving turnaround time
• Responsible for reducing backlog in laboratory testing by greater efficiency and streamlining resources
• Provide monthly metrics for QC Analytical Chemistry for OOS and OOT investigations
• Responsible for scheduling weekly assignments to chemists and make sure timely release of commercial products to meet market demand
• Manage 6 QC chemists and schedule daily release testing schedules, for validation testing, and stability testing
• Per 503B guidance, release testing and stability testing included, assay, impurities, pH, color, clarity and HIAC
• Validation testing included having kickoff meeting with QC chemists and senior scientist to decide method development testing followed by pre-validation testing after which validation/verification testing was performed
• Support validation of analytical testing procedures, including writing, and approving protocols, and reports, test methods with continuous improvements and efforts consistent with company standards
• Author stability related SOPs, protocols and final reports for all pipeline product/materials
• Maintain stability schedules for internal stability testing
• Reduced overtime levels while also improving turnaround time
• Responsible for reducing backlog in laboratory testing by greater efficiency and streamlining resources
• Supervise day-to-day Quality Control activities for laboratory, ensuring compliance, accuracy and timeliness of specified testing, personnel oversight, data review analysis, and trending
• Ensures all testing and departmental documentation meet company and cGMP regulatory standards
• Work with quality control management team to continuously improve quality, compliance and efficiency of QC operation.
• Presents project status to QC Manager
• Write/revise SOPs, protocols and reports
• Effectively communicate internal issues related to performance, processes, and procedures
• Development of staff members at varying levels of QC and validation experience
• Trend OOS, OOT’s and CAPA’s for monthly metric meeting to inform upper management
• Complete 90 day and annual evaluations for direct reports
• Draft CoA for batch/lot release following approval of all data for QA approval
• Review all analytical data for accurate testing and cGDP as well as cGMP guidelines.

Performed analytical tests including method development under supervision of senior level scientist; collaborated with other analytical scientists in team environment for project support and general lab operations

• Initiate and revise SOP, batch records and ensure documentation meet compliance expectations
• Partner with other groups to coordinate documents for major projects or change management
• Performed major analytical test methods utilizing chromatographic, characterization and wet chemistry techniques for drug substances and drug products (including HPLC) in pre-clinical and early clinical stages under ICH guidelines
• Collaborate with formulation scientists for all necessary methods development and perform testing as required under GMP conditions
• Perform HPLC method development under supervision for drug products using ICH guidelines
• Developed and implemented analytical methods to support process development and formulation development
• Perform method qualification testing and wrote development reports for validation testing done in CRO facilities
• Provide support to process and formulation scientists with analytical instrument trouble-shooting and in-process testing
• Work together with other analytical team members to maintain lab instruments and general supply inventory, assist in documentation management
• Compile method development reports for methods that were developed before transferred to CRO/CMO
• Represented Analytical Development data in cross-functional teams coordinating project-specific activities
• Manage all ongoing GMP stabilities that were outsourced
• Keep records of pull date and pull point
• Update all data received (assay, dissolution, moisture, SEC, Purity) into excel files to be shared with various functional departments.
• Update all data received (assay, dissolution, moisture, SEC, Purity) into JMP software to be shared with various functional deptartments.
• Write stability reports for GMP studies that were used in filing in IND process
• Quality Assurance Associate
• Responsible for GMP documentation process to support manufacturing operations; Provide expertise and experience when reviewing draft SOPs and batch record forms
• Initiate and revise SOP, batch records and ensure documentation meet compliance expectations
• Partner with other groups to coordinate documents for major projects or change management
• Carefully review reports that were generated by CRO/CMO for Early Phase Validation of Analytical methods against protocols designed for each analytical method within ICH guidelines
• Review method development reports generates in-house with data compiled by chemists e.g
• SEC method development and early pre-validation experiments
• Have written SOP for production purposes with ICH guidelines
• Review finished product certificate of analysis (COA) against release finished product specification/CoA
• Review ELN (Electronic laboratory notebooks) for chemists working in similar projects under ICH guidelines
• Ensure there is no conflict of interest between regulatory responsibilities and actual daily activities
• Be independent reviewer and approver with respect to manufacturing and process/ product development units
• Report on product, process and system risks—and keep management informed
• Review and approve/reject any document that gives work instructions and set requirements such as procedures, protocols, test methods, and specifications—including changes to these documents
• CMC Regulatory
• Edit Module 3 templates for Phase 3 in filing IND
• Update GMP Stability Data in Module 3 for feasibility batches use in IND filing for Phase 2 and Phase 3
• Update Analytical Procedures in Module 3, that were used in validation and analysis of stability data
• Work to establish Specifications for Phase 3 (Stability chemist) in filing for IND for Phase 3
• Write stability reports for GMP studies that were used in filing in IND process.

• Performed GC Testing for in-process and finished product scaffolds for residual components which were within GMP and GCP compliance
• Assisted in polymer synthesis and reviewed batch records for polymer synthesis
• Reviewed data for validation testing done by junior chemists as well as performed validation experiments for GC testing
• Performed analytical / mechanical testing of incoming and in-process materials / chemicals / products
• Assured materials and products are tested to applicable standards with GCP guidelines
• Assisted in developing methods and procedures for material and product testing
• Assisted in equipment procurement and IQ/OQ activities within GCP and GMP compliance
• Assisted in process validation through in-process and finished product testing
• Authored/reviewed analytical/mechanical tests methods
• Manage Raw Materials release and Stability Testing
• Method Validation/Transfer within GMP and GCP guidelines
• SOP Development & Writing with GCP guidelines
• Employee Training for better documentation within GMP guidelines
• Employee Performance reviews for junior chemists
• Batch Record Review and Disposition
• Deviations, Change Control, Quality Investigations
• Validation and Validation Documentation Review
• Implement, Manage and Maintain QC Equipment Maintenance, Calibration and Qualification schedules
• Polymer synthesis for lot qualification.

• Developed analytical methods, validated, qualified, methods within GMP compliance under supervision utilizing Agilent HPLC and Empower for processing data
• In-process samples as well as stability samples were also analyzed to ensure phase characterization of API
• Contributed by assisting in writing and following SOPs, test methods and other GMP documentation such as qualification of protocols, method transfer protocols and validation protocols
• Accomplished understanding drug development process, including chemical development and their impact on analytical method development, validation, and method transfer
• Gained ability to work in fast pace environment, manage priorities, and maintain timelines for multiple projects
• Provided QC support in response to OOS/OOT investigations and regulatory responses related to analytical testing and analysis.

• Performed R&D stability testing for pharmaceutical samples; finished drug products using established methods with guidance from supervisor or senior scientist
• Methods tested included cleaning validation, assay, degradation, dissolution, blend uniformity, and content uniformity
• Projects included working with drugs such as Lexapro, Namenda, Milnacipran, Linaclotide
• Samples were analyzed using HPLC, GC, UPLC and Karl Fischer and processed with Empower and Total Chrom.
• Under GMP compliance
• Validations of methods for FDA submission were performed ensuring that product meets pre-defined corporate and USP specifications

Method Development Chemist

• Achieved clear understanding effective method validations for various products for FDA submission
• Contributed by testing samples to insure compliance with FDA and cGMP requirements according to approved written SOP procedures and specification
• Played significant role in supporting pharmaceutical analysis department during method transfer
• Accomplished effective troubleshooting skills to increase laboratory efficiency
• Provided QC support in response to OOS/OOT investigations and regulatory responses related to analytical testing and analysis
• Review of analytical data generated at CMO/CRO associated with manufacture and release
• Assisted in authoring and quality control related sections for regulatory filings for NDA and FDA submissions

Scientist II

• Completed quantitative and qualitative analysis of in-process, clinical, stability, and NDA samples
• Effectively performed HPLC/UPLC troubleshooting to increase laboratory efficiency

Scientist I

• Performed analysis of various samples that were in category of in-process, clinical, stability, and NDA samples and gained ability to work in fast pace environment, manage priorities, and maintain timelines for multiple projects
• Effectively performed HPLC/UPLC troubleshooting to increase laboratory efficiency.

• Mastered the knowledge behind human immunodeficiency virus (HIV) transmission and pathogenesis
• Maintained the responsibility for maintaining tissue culture, including human macrophage isolation from whole blood followed by of cloning and transfection
• Immunocytochemistry of fixed and unfixed PBM’ studying expression and conformation of different proteins of cell surface
• Isolated lymphocyte by ficoll gradient from whole blood, where lymphocytes were used to isolate CD4+, D8+ and CD14+ cells for flow cytometry experiments
• Lymphocytes were also used for neutralization assays to study the blockage of viruses with certain antibodies and for measurement and characterization of viral protein (p24/p27 elisa).