Sanjay Joshi

Pharmaceutical Professional with depth and breadth of experience in analytical method development, validation, and transfer. Known for dedication to continuous improvement and the ability to solve complex problems. Goal-driven and highly organized leader with a positive attitude and excellent communication skills. 

Areas of Expertise include:

• Management of Analytical Laboratory
• FDA | Health Canada GxPs | ICH Guidelines | Quality Management Systems
• Analytical Method Development | Method Validation | Method Transfer 
• Laboratory Instrumentation: HPLC / UPLC, Automated Dissolution, Empower, LIMS
• Stability Management 
• Planning and Leading Investigations as part of OOS, OOT, DR, and/or CAPA
• Troubleshooting Analytical Test Methods and Instruments IQ/OQ/PQ
• Leadership: Recruiting, Training, Coaching, Performance Management 
• Product Analytical Specifications
• Technical writing for CMC submission

Sanofi, Toronto, Canada

Manager Quality Operations                                                                                                                Feb 2023-Feb 2024

• Authored Product Analytical Specifications for all the raw materials and Single Use Systems, to be onboarded at Sanofi Toronto B200 facility. 
• Ensured compliance with Sanofi’s Global and Toronto guidelines. 
• Co-ordinated with suppliers, cross functional stakeholders in the US, Canada, to ensure required supporting documentation was on file for the proposed specifications. 
• Met stringent deadlines to ensure specifications were approved for timely onboarding of the materials. 

CHARTWELL PHARMACEUTICALS, Carmel, NY, USA

Senior Scientist, Quality                                                                                                                       April 2022-Feb 2023

• Developed and validated robust analytical test methods for raw materials, finished products to ensure compliance with USP/EP.
• Developed and validated robust analytical test methods for cleaning validation and contributed to design of Cleaning Validation Master Plan.
• Reviewed and executed IQ/OQ protocols for new instruments installed in the laboratory
• Drafted specifications for incoming raw materials and authored method development and validation reports for regulatory submissions.

Lannett company Inc., Carmel, NY, USA

Senior Scientist, Quality                                                                                                              October 2018-April 2022

• Developed and validated robust analytical test methods for finished products.
• Carried out Method Verification for compendial methods and Method Transfer between different sites.
• Developed and validated robust analytical test methods for cleaning validation.
• Reviewed and executed IQ/OQ protocols for new instruments installed in the laboratory
• Drafted specifications for incoming raw materials and authored method development and validation reports for regulatory submissions.

BIMEDA MTC ANIMAL HEALTH INC, Cambridge, ON, Canada

Senior Analytical Method Development Chemist                                                     August 2017 – January 2018

• Developed and validated Analytical test methods for Veterinary Pharmaceutical formulations
• Authored Product development and Method Validation Reports for regulatory submission.

Purdue Pharma, Pickering, ON, Canada                                                                                       2005-2016

Analytical Scientist, Pharmaceutics and Analytics, R&D | 2013-2016

Supervised R&D department’s analytical operations and maintained regulatory compliance. Formulated weekly work plans for direct reports (4 Analytical Chemists). Strategized analytical method development for several projects and led R&D team, focused on achieving efficiencies.

• Contributed to new product development strategies for innovative drug-release platforms.
• Authored method-validation protocols and reports for clinical trial applications and new drug submissions, enabling timely product approvals and launches.
• Transferred HPLC methods to UPLC, shortening run times, generating substantial cost savings, and reducing detrimental environmental impact.
• Spearheaded effective decision-making that impacted product quality issues, product investigations (CAPAs), and change controls for compliance with Quality Mgt. System.
• Served as Subject Matter Expert (SME) for technology transfer within Quality and contract manufacturing sites in the US and UK.   
• Safeguarded data integrity; maintained project archives for R&D through Empower administration.
• Led technology upgrade projects for Empower and LIMS Phase II, elevating the department with higher industry standards.
• Trained, coached, developed, and managed performance of direct reports, achieving optimal department productivity. 

Analytical Chemist, Pharmaceutics and Analytics, R&D | 2005-2013

Tested raw materials, finished products, intermediates, and stability samples. Authored and executed test methods, method validation protocols / reports, and departmental SOPs. 

• Developed and validated robust analytical test methods, ensuring timelines for clinical trial applications were met.
• Established instrument calibration & validation program, facilitating tracking/management of calibration and validation for all relevant instruments according to cGMP regulations. 
• Improved quality of testing and reduced equipment downtime by calibrating and troubleshooting analytical instruments.
• Reviewed and executed IQ/OQ protocols for new instruments installed in the laboratory.

Additional Related Experience

Pasons Chemicals Pvt. Ltd., Mumbai, India                                                                 1992-2003

Technical Manager

• Designed and set-up Quality Control and R&D laboratories for pharmaceutical and specialty chemical manufacturers, on a turnkey basis. 
• Provided analytical-method development solutions for scale-up operations associated with isolation and purification of active ingredients in natural products by utilizing Waters Analytical HPLC, Semi-prep HPLC, & Kilo-prep production-scale HPLC.

Waters India Ltd., Mumbai, India                                                                                                                  1989-1992

Regional Manager, Western India

• Led western India regional office, providing marketing, sales, and support for Waters HPLC systems.

Materials research instruments, Mumbai, India                                                      1986-1989

Application Specialist, All India

Sales, Marketing, Installations and application support for Dionex Ion Chromatographs, Bruker HPLC and Elga Water Purification Systems for all India.

Salesworth india pvt.ltd. Mumbai, India                                                                       1985-1986                                                          

Application Specialist, Western India

Sales, Marketing, Installations and application support for Waters HPLC Systems in Western India.

Ph.D., Analytical Chemistry, University of Bombay, India, equivalent to a Canadian PhD, per WES

M.Sc., Inorganic Chemistry, University of Bombay, India