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Improvement Manager Scientist

Location:
Hawthorne, NJ
Salary:
175000
Posted:
January 13, 2022

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Resume:

Subhra Bhattacharya, Ph.D.

https://www.linkedin.com/in/subhra-bhattacharya

Email: adpw0z@r.postjobfree.com

Address:

** ***** **** *****

Hawthorne, NJ 07506

Phone: 608-***-****

Professional Summary

Experienced professional well versed in bioanalytical chemistry, biotechnology, synthetic organic chemistry, medicinal chemistry, and analytical chemistry, extensive experience in pharmaceutical and biotech industries.

Experienced in biochemistry, structural biology, and nucleic acid biochemistry.

Experienced in the chemical manufacturing environment.

Offered scientific, strategic, and managerial leadership for the success of the company.

Collaborated with cross functional team and cross divisional business units. Strong organizational, interpersonal, and managerial expertise to motivate and inspire team.

Maintained team cohesiveness for the successful execution of the projects.

Contributed over $100 million business revenue each year for the success of the company.

Passionate to lead drug discovery work.

Highly qualified and accomplished scientist with multi-faceted skills, process chemistry and process development experience with proven track record of innovation.

Accomplished project management /completion of multimillion dollar projects within time and budget.

Accomplished and exceeded organizational goals year after year.

Professional Experience

Experienced professional with strong synthetic organic chemistry, medicinal chemistry, and analytical chemistry background.

Experienced in cancer biology and anti-cancer drug development work.

Experienced in structural biology, pharmacology, DMPK and early development.

Characterization of intermediates, impurity identification using analytical instruments.

Experience in protein isolation, purification, enzyme kinetics, assay design and pharmacological evaluations.

Working knowledge of planning, execute, interpretation and optimization of structure activity relationship (SAR) for physicochemical and pharmacological function of the potential API.

Managing and partnering with contract research organization for the portfolio of drug candidates.

Experienced in design, plan and execute multi step synthesis for organic molecules.

Experienced in working in the environment of solvents and chemicals manufacturing.

Maintained high standard of laboratory safety.

Excellent problem-solving skills.

Cross functional collaboration and team management experience.

Experienced in IVD product development.

Job Experience

Abzena

Global Program Manager 2022 -

Presided over scientific projects for antibody drug conjugate. Managed group of scientists for execution of cell line development, mAb generation and linker-payload synthesis within timeline and budget. Lead the analytical method development work for purification and characterization of drug substances and drug products.

Thermo Fisher Scientific, Fair Lawn, NJ 2018 – 2022

Principal Scientist / Senior Manager

Presided over product development, product management, marketing strategy, and new product development. Demonstrated functional leadership in R&D, allocated resources, ensured budgeting, and scheduling for the project completion.

Expertise in purification and impurity identification for large and small molecules.

Inspired and motivated the team for high standard work and recognized the team/individual for achievement. Fostered safe environment, inspired colleagues, retained talents. Focused on building highly engaged team leveraging collaboration, diversity, and inclusive culture.

Created over $20 million in new revenue while saving more than $5 million in process development.

Cultivated atmosphere of motivation and teamwork through efficient team building, unifying staff to achieve organizational goal, team, and individual goals.

Motivated, empowered, and developed people by setting vision.

Maintained efficient project workflows by facilitating regulatory team and project meetings,

Performance management of the teams for success across numerous complex projects.

Excellent problem-solving skills.

Implemented SOP for analytical methods, emphasizing quality control for chemicals, solvents, and special chemicals.

Spearheaded lucrative product launch, targeting chromatography and mass spectrometry customers.

Expertly delivered multiple R&D projects on schedule and within budget.

Demonstrated broad technical knowledge, steered bottom-lime performance in developing products/processes and manufacturing.

Managed several cross functional and cross divisional projects.

Drove several continuous improvement initiatives, safety matrix and safety guidance for Manufacturing and Operation.

Bolstered advertising efforts by creating marketing brochure, posters, and publications.

Thermo Fisher Scientific, Fair Lawn, NJ 2012 - 2018

Senior Scientist

Developed and improved processing of chemicals utilizing quality by design approach.

Implemented process improvement for several chemical blends and chemicals.

Developed assay for chemicals testing.

Experienced in analytical and regulatory requirements, including strong working knowledge of cGMP, ICH, USP, EP and other relevant regulatory requirements. Good technical understanding of all aspects of analytical testing for small molecule pharmaceutical products. Experienced in providing oversight for product release and stability testing at contract manufacturers and laboratories.

Pursued and executed multiple projects successfully and increased business revenue and growth.

Developed and validated test methods in compliance with ICH guidelines.

Experienced in IVD product development.

Created $10 million in revenue.

Supplier quality management.

Built high quality standards in AR&D through new revised SOPs, training in the department.

Developed comprehensive analytical chemistry, liquid chromatography, and mass spectrometry experience.

Penned, implemented, and guided staff through correct SOP preparation, implementation, and revision.

Thermo Fisher Scientific, Milwaukee, WI 2006 - 2011

Research Scientist

Worked actively to develop phosphoramidite chemistry for manufacturing large scale batches.

Contributed to all custom and new product development projects for phosphoramidites, nucleotides, and nucleosides.

Pinpointed impurities and characterized products by GC, GC-MS, GC-MS/MS, LC-MS, MS/MS, NMR etc

Evaluated and verified product specifications and trained lab personnel in use of various equipment and software. Design and implement analytical methods for new products and chemicals, inclusive of drug products, leveraging quality by design approach.

Conducted comprehensive analysis to identify impurities and develop effective process chemistry improvements. Performed stability studies on new chemicals, including packaging components. Deliver support and troubleshooting to OOS investigation. Partnered with both external and internal customers on development. Conducted extractable and leachable study from packaging components.

Drove product launches in collaboration with manufacturing, operation, and quality teams.

Managed analytical work with external vendors and leaded lean process implementation.

Compiled and presented relevant technical reports and documentation for senior management. Identified and qualified new vendors for supply chain management.

Pursued and executed on product delivery in partnership with QC, planning, sourcing, manufacturing, sales and marketing, and finance teams.

Participated in internal audit and aligned other departments with ISO requirements.

Supported manufacturing and operation for the upstream bioprocessing and custom synthesis.

University of Wisconsin, Madison, WI – 2003 – 2005

Scientist

Studied protein-protein interaction related to actin/troponin and tropomyosin.

Engineered site specific mutagenesis for actin, tropomyosin, and troponin; screened, cultured, and purified the engineered protein for evaluation.

Discovered assay techniques for identification and interaction studies.

SLIL Biomedical Corporation, Madison, WI, 1999 – 2003

Scientist

Synthesized and evaluated several polyamine analogs against several cancer cell lines.

Developed and validated HPLC and other assay methods for the quantitative determination of impurities, active compounds.

Identified drug metabolites (DMPK) by LC-MS.

Investigated mechanism of action of the polyamine analogs in cancer cell lines.

Performed mammalian protein purification; tried to investigate active cancer specific protein.

Education

Post-doctoral research (protein separation and characterization, protein engineering, molecular biology): UW-Madison, 1995 - 1999

Post-doctoral research, (structural biology, protein and nucleic acid separation and characterization): Bose Institute, Kolkata, 1992 – 1995

Doctoral work (Ph.D. in synthetic organic chemistry) – Jadavpur University, Kolkata, 1986 – 1991. Title of the Ph.D. Thesis: Studies in Heterocyclic Systems Synthesis of Biologically Important Heterocycles and Investigations on Transmission of Substituent Induced Electronic Effects.

Training

From Thermo Fisher Scientific

Developing Front line Leader – 2021

Management Essential - 2019

AMA Project management training - 2018

Continuous Improvement Manager Training - 2018



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