Quality Assistant

Cambrex Corporation (Halo Pharmaceutical Inc.) (Jan/2018/- Jun/2020)

Supervisor Analytical Services

Implemented and maintained Quality system in laboratory and supports companies CDMO business activities.

Assisted the director to track and monitor the department budget (operational expenses, capital expenses and head counts) according to the agreed budget.

Hired and trained Analytical Quality Service staffs to serve our clients. Ensures Analytical Quality department is in compliance with cGLP and cGMP.

Routinely provided training for SOPs, CAPA implantation, new hire training to Quality control and R&D team members. Developed training programs and Monthly conducting cGMP training to Laboratory personals.

Led analytical discussions with clients for assigned clients' analytical projects, participate in internal audits, client audits.

Provided internal and external technical support for methods development, transfer and validation, Quality control Release activities.

Responsible for scientific proposals, procedures and reports.

Worked closely with other functional areas such as Project Management,, Quality Assurance and Commercial Manufacturing as well as with clients to meet the timelines and requirements

Participated in research and development, Quality Control activities, and is accountable for preparation of all technical documents to support our clients' submissions for INDs, NDAs, and ANDAs, etc

Wrote analytical protocols, analytical testing procedures, and pharmaceutical development reports, analytical APRs etc

Routinely involved Initiating change controls, leading investigations, root cause analysis and implementation of CAPAs.

Participated Vender qualification, auditing outside contracting laboratories, sending samples to contract labs for testing and communicating effectively.

Handled Control Substances, Safety trainings, hazardous waste other routine duties.

Johnson &Johnson Consumer Companies (Oct/2012 to 2017/Dec) (as a Kelly OCG Manager)

Project Lead

Managed projects and workload to meet aggressive timelines.

Evaluated gap assessment for technical transfer projects and providing inputs for budgets and FTE’s.

Provided guidance and feedback to junior chemists to execute test method developments, method validations, method transfers, technical investigations and troubleshooting.

Overseen Method developments, validations, Technical transfers and stability studies.

Wrote system policies, procedures and writing SOPs for analytical equipment’s, software, LIMS and Laboratory procedures.

Monitored, report individual tasks and cumulative progress to management.

Prepared and reviewed stability reports, transfer reports, method validation protocols, method validation reports and Analytical APRs.

Participated in the design, development and implementation of department strategies, provided recommendations in their area of expertise

Participated in Vender qualification, auditing outside contracting laboratories, sending samples to contract labs for testing and communicating effectively.

Led cross-functional teams on assigned projects to successful conclusions

Regularly interacted with subordinates, outside contacts and functional peer groups at various management levels

Built and maintained excellent relationships with contractors and corporate partners

Knowledge of EU, Canada and FDA regulations, guidelines

Communicated with all levels within the company and can act as liaison / representative both internally and externally

Performed complex tasks independently using project management skills and working on multiple projects simultaneously

Prepared and delivered effective regulatory CMC documents for internal and external teams

Ensured the alignment of regulatory CMC strategy with department and corporate objectives, for assigned projects.

Aurobindo Pharma USA Inc (2009- 2012)

Group Leader

Prepared documents for (eCTD) electronic submissions adhere to current regulatory submission practices

Demonstrated expert knowledge of FDA regulations, guidelines, and precedents related to drug product development, including Quality by Design (QbD) initiatives

Guided and led the project group, stability group, Finish product release and Raw material release groups.

Managed a group of fourteen members. Responsibility of a group leader includes hiring new chemists, providing training, managing the group and preparing performance reviews.

COAs, Protocols, Change controls initiating, reviewing and approving of day today activities personals.

Handled OOS, OOTs, deviations and laboratory events, CAPA implementation.

Overseen Process validation batches and commercial batch testing, cleaning activity testing and releasing.

Identified and developed new and improved analytical test methods. Work with external resources to identify and develop new technologies. Develop appropriate experimental plans, models and hypotheses for technical problems.

Represented the department on cross-functional teams and meetings. Provide technical training and coaching, develop and follow project timelines, and provide technical leadership and expertise to project teams.

Over seen Method developments, validations, Technical transfers and stability studies.

Wrote the system policies, procedures and writing SOPs for analytical equipments, software, LIMS and Laboratory procedures.

FDA, external agencies inspection handled and responded their quarries.

Conducted internal laboratory audits and improved the cGMP policies and procedures.

Handled Control substances, reconciliation and destruction activities.

Participated in budget planning in departmental group activities.

Sigma Pharm Laboratories, LLC

Group Leader (2006-2009)

Setting up the Analytical lab: Bought the analytical equipments, wrote the system policies, procedures and wrote SOPs for analytical equipments, Class VP software, Empower software and Laboratory procedures.

Involved in Vender qualification, audited outside contracting laboratories, sending samples to contract labs for testing and communicating effectively.

Hired new chemists, trained, guided, managed projects and daily work flow.

Handled Multiples projects starting from API, Excipients qualification, developed, validated methods, tested, released materials, stability tested, filled product to FDA, and successfully handled the FDA, after getting the approval QC support for commercialization.

Par Pharmaceuticals, Inc, (2001-2006)

Research Support (2004-2006)

Determined priorities, timelines, and resources for the Analytical Research & Development group. Developing and reviewing analytical protocols, methods and procedures. Wrote, reviewed and approved, validation protocols and final reports.

Participated as a member on Product Development and Project Teams. Preparing analytical CMC sections of regulatory submissions and eCTD format support. Communicating effectively and build positive relationships with associates and external contacts as necessary to assure the timely reporting of results. Responsible for continually striving to identify and improve processes, procedures and productivity. Writing SOPs for analytical equipments, Empower software and Laboratory procedures.

Chemist (2002-2004)

Performed Validation studies of in-house, BP/EP and USP analytical method for various Raw material and Finished Products. Studies including Stability indicating methods, Forced Degradation /Stress studies, Precision, Accuracy, Linearity, LOD/LOQ, Robustness and Ruggedness.

GC Residual solvent method development, Method Validation and OVI analysis by Using Agilent5890, 6890 GCs with different sampler like Auto-injector and Headspace sampler and different detectors like FID and TCD.

HPLC method development, UPLC, LC/MS Method developments, Cleaning verification method development and validation.

Performed analysis of Stability, In-process, Process Validation, Raw material and Finished Products testing using USP and BP/EP methods.

Expertise in doing Drug Potency Assay, Impurity Assay, and Content Uniformity & Dissolution Assay, Involved in day-to-day Instrument troubleshooting. Calibration of various instruments including HPLC Auto-injectors, Pump and UV detector. Residual Solvents.

Experienced in doing all Inorganic Qualitative and Quantitative Analysis.

Junior chemist (2001-2002)

Performed Dissolution of Stability samples, R&D samples and Finished Products.

Familiar with Physical and Chemical Analysis of API (Weight Variation, Gauge Measurement, Hardness, Friability, Disintegration Time, Content & Blend uniformity, TLC, Water Testing, Viscosity measurement, Particle Size, Bulk & Tap Density.

Calibration of various instruments including GC (Auto-injector and Headspace), HPLC, Auto-injector, Pump, UV detector, pH meter, Karl Fisher and Centrifuge unit.

Strong background in testing of Active Pharmaceutical Ingredients and Pharmaceutical Excipients using instrumental analysis (Infrared Spectroscopy, Surface area measurement, Particle Size Analyzer, Differential Scanning Calorimeter, UV-Visible Spectroscopy & Polari meter).

Bharathiar University, Coimbatore, India

Research Assistant (1999-2001)

Familiar with all kind of synthetic and characterization techniques, wet chemical analysis, Inorganic Qualitative and Quantitative Analysis, Bio-chemical and Microbiological Testing (Identification, Isolation & Sterilization).

Project Thesis

NMR spectral analysis of a few ‘Alkyl substituted N-bromo 2,6 diphenyl piperidone-4-ones’ and ‘Alkyl substituted N-Hydroxy 2,6 diphenyl piperidin-4-ones’

Synthetic studies on Carbazole Alkaloids and structural identification by NMR, IR and Mass spectral interpretations.

INSTRUMENTATION SKILLS:

Expertise on modern analytical instrument HPLC (Waters alliance) equipped with various detectors such as PDA., RI, Corona CAD (Corona Charged Aerosol Detection).

Expertise on modern in GC (Agilent 6890, GC Shimadzu 2014), HPLC, UPLC, LC/MS(ESI), UV-VIS, IR, Malvern Mastersizer (S, X and 2000), DSC, Micrometrics Surface area measurement and fiber optics dissolution measurement.

Polari meter, Viscometer, PH electrodes, and tap density, bulk density instruments and Karl Fisher instruments

SPECIAL TRAINING:

Short course on method development and method validation.

Short course on HPLC Instrumentation and troubleshooting,

Short course on GC Instrumentation and troubleshooting.

Short course on Instrumentation LC/MS and Interpretation.

COMPUTER SKILLS:

Windows, MS Word, MS Excel, MS PowerPoint.

Empower software and experience in handling different interfaces.

EDUCATION:

B.S. Chemistry, Bharathiar University, Coimbatore, India.

M.S. Chemistry, Bharathiar University, Coimbatore, India

M.Phil. Organic Chemistry, Bharathiar University, Coimbatore, India

WORK PERMIT:

US Citizen

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