Project Manager Manufacturing

Sushil Mohapatra

Email: *********@********.***

Address: * ******** ******

City: Winchester

State: MA

Zip: 01890

Country: USA

Phone: 781-***-****

Skill Level: Management

Salary Range: $140,000

Willing to Relocate

Primary Skills/Experience:

See Resume

Educational Background:

See Resume

Job History / Details:

SUSHIL MOHAPATRA, PhD

7 Sheridan Circle, Winchester, MA 01890

Home Tel: 781-***-**** / 781-***-****, Cell: 617-***-****

*********@********.***

PROFESSIONAL SUMMARY

Biochemist; (Protein chemist) with several years of down/ upstream process experience of monoclonal antibodies (Mc Abs), cDNA origin proteins purification and API Manufacturing (grams). using all kinds of Column Chromatography (SEC, IEC), HPLC, RP-HPLC, SDS PAGE, IEF, MF/UF & TFF sterile liquid handling, fill and finish, Bio-Analytical operations, container closure systems. Expert in budgeting, staff recruiting and training, handling multiple project management; ensure that staff members meet compliance and safety standards to increase the company growth potentials & delivering the product on time.

Specialties:

* Process development & Manufacturing of Monoclonal antibodies & cDNA Protein origin drugs

* Tech transfer from R & D to manufacturing of Monoclonal Abs.

* CMC, SOPs & Batch record writing as per ICH guidelines

* Downstream and upstream process of therapeutic protein drugs

* Best use of all TFF and Chromatography processes ( Testing by SEC & Ion exchange chromatography)

* On the spot to fix all Technical troubleshooting in manufacturing suits.

* CRO, CMO, Audits and maintaining of protein batch records & management

* Proteins; purification & analytical requirements (HPLC, SDS PAGE, CE, IEF, TFF,A280, AA analysis)

* Knowledge of container closure system validation

* Audited all Batch records and corrections as per FDA rules

* Use of all Analytical techniques along with the steps of manufacturing process

* Drug Productivity increase and mass balance

* FDA Audits

* Multiple project management

* Group building and Technical trainings to subordinate staff members

* Taking care of overall responsibility at CMO site

PROFESSIONAL EXPERIENCE

CLINIGENE INTERNATIONAL, Bangalore, India 2011 - present

Sr. CONSULTANT, BAL Division (remotely working from USA)

* Downstream & upstream process of cDNA origin therapeutic proteins with all CGMP and ICH guidelines

* Validation, Formulations of protein drugs and Sterile fillings, Lyophilized fillings, containers & closures

* Fermentation of DNA origin drug manufacturing, using bioreactors (Monoclonal Abs.)

* Looking at the documentations and operational part of CGMP manufacturing, Bioanalytical staff of 43, 6 Ph.D. and 17 Masters and rest are graduates

* Assay development, validations, report writings, tech support and tech transfers, Batch record review, SOP writing and corrections, etc.

* Day to day activities involved in interaction with various departments, Regulatory, CMC, post marketing, and R & D staffs.

Assays:

* Enzyme Linked Immunoassay (ELISA) / Radioimmunoassay (RIA) / BIA-Core based assay, HPLC, SDS PAGE, IEF, 280 and all bioanalytical methods.

* HPLC based assays(SEC & RP) to evaluate their % purity, and Mass Balance

* Biomarker assays using kits, ELISA and Clinical Analyzers

* Cell-based assays- Functional and Neutralizing anti-therapeutics antibody assays

* Development, update & implementation of Policies & Procedures, and Standard Operating Procedure (SOP) for the GLP & CLIA compliant Immuno-analytical operation

* Participation in FDA audits;. Formulating scientific and procedural responses to citations(483s) from the regulatory agencies.

* Responding to new business inquiries and costing of potential new projects

* Overseeing the successful monoclonal Abs/, protein therapeutics of all protein drugs for phase I to III .

CUBIST PHARMACEUTICALS INC., Lexington, MA 2004 - 2010

Senior Manager (Assoc Director), Operations, Chem. Development Dept.

Directing and coordinating the work efforts of a group of twelve scientists' in house and outsourced scientific teams at national/international CROs/CMOs. Major functions include organizing twelve-member project team, developing strategic time-lines, identifying key milestones and resource needs and communicating those to Sr. Director/VP of R&D. Provide leadership and overseeing of Parenteral drug manufacturing Labs at CMOs sites,

* Developed and wrote all manufacturing protocols, batch records down/upstream processing of large molecules (Monoclonal Abs) under cGMP, API manufacturing, Sterile fill & finish; their Analytical assay development, operational recruiting, participation in annual budgeting, managing scientists, equipment's (HPLC; 5 API 4000), GC and their validation & Tech. operations, providing technical support and coordinating services.

* Additional responsibilities include CMC writings; manufacturing under 21 CFR Part 210-211 of APIs, GLP and FDA audits, smooth laboratory operations providing functional services such as ELISA's, SEC, Affinity & Ion-Exchange chromatography for cell harvest, ultra-centrifugation, microfiltration (UF/MF, TFF) sterile API handling, Fill and finish, Process troubleshooting & fixing Endotoxin & Virus removal .

* Scale up manufacturing of Mc. Abs. large molecules under ICH guidelines ; provided leadership for the production team and facilitated investigations and resolution of validation failures, process deviations, abnormal results, customer complaints and inquiries, and other quality performance indicators

* Supervising the technical aspect of protein production line, Analytical development and Validation of several protocols, assays methods i.e., ELISA, HPLC based assays, IEF SDS page, CE, Buffer exchange by TFF (tangential flow filtration) micro filtration. Utilized experience with chromatography methods (SEC), cell surface binding & Immuno-assays development, receptor binding assays for product purity and bio=viability,

* Staying abreast of scientific and regulatory issues that can affect different projects. This includes large molecules & Protein purification & assay development; method validation procedures.

* Designed, Reviewed validated and approved all experimental protocols for production of Monoclonal Abs. for 7 different drug candidates taking them from Phase I to III production.

* Supervised several antibody productions for phase I- III, their batch records, SOPs with GLP / cGMP compliances at CROs / CMO sites as per the ICH guidelines and provided management with technical summations and investigative reports.

* Worked cross functionally with QA., Technical Operations, Regulatory and other similar departments Directed the development of new analytical methods and validations where required, and new technologies, Tech transfers as applicable to support the business growth proving increase in Company's productivity goals.

* Trained subordinate team of scientists, and familiarizing them with new tech.(s), accordance to regulatory guidelines.

Selected Accomplishments

* Avoided a catastrophe. Cubist was paying a FTA basis of $7.5 million quarterly to an, Israel-based company to carry on a Hepatitis B drug research. Corroborated impurities by means of examination by two independent CRO's. Cancelled this Hepex B drug candidate from Cubist's pipe line. Saved Cubist an embarrassment at FDA as well as $7.5 million of quarterly payments to the Israeli company.

* Met a difficult deadline. Cubist had production of several small molecules drugs in a cGMP suite at a CMO. As a deadline for a phase 1 clinical trial approached, a pipe burst and several gram quantities of this drug in the last stage of its production were lost, jeopardizing phase I clinical trial. Stayed at the plant site to ensure that nothing further would go wrong. Met the deadline, saved the batch and went to phase I trial on time.

* Succeeded under pressure. There was not enough time to complete a drug production batch to go to clinical trial, and if Cubist could not deliver this batch of the new produced drug to clinic on time, consequences would be dire. Convinced the union steward to keep production going non stop during a holiday period. Personally supervised 24/7 operations. Sent the final API to clinic two days early.

* Surmounted regulatory obstacle threatening production. The EMEA was not accepting Cubist's production at the Sweden site, since American-made filters were being used in a European production plant. Researched all aspects of the problem and found that the filters were actually made in Europe and then sold in USA. Obtained permission from the European authorities to continue production without interruption.

GWATHMEY INC., Cambridge, MA 2002 - 2004

Principal Scientist

Managed 6 scientists in down-stream processing; 4 in analytical chemistry section. Client interaction, protocol & SOP writing, FDA inspection and project management. Practiced twelve years of experience with harvest, cGMP manufacturing of APIs, Buffer exchange by TFF; micro filtration, tangential flow filtration (TFF). Utilized experience with primary and secondary purification, studies

* Supervised manufacturing of several Mc. Abs.(Hands on) large molecules under ICH guidelines ; provided leadership for the production team and facilitated investigations and resolution of validation failures, process deviations, abnormal results, customer complaints and inquiries, and other quality performance indicators

* Worked cross functionally with Quality, Technical Operations, Regulatory and other similar departments

* Managed Manufacturing GMP Labs and departmental budgets and budgets for the Group as a group Leader

* Supported Business Development efforts through customer visits and contact as necessary to develop new business and support existing BD staff to increase company growth potentials.

* Provided Technical Expertise in Chromatographic Methods and Techniques, advance trouble shooting and problem resolution for technical issues

* Trained subordinate team of scientists, and familiarizing them with new tech.(s), accordance to regulatory guidelines.

Selected accomplishment

* Reversed declining sales. Devised and led execution of an improved sales and marketing strategy. Promoted Gwathmay's capabilities at numerous industry conferences. Increased sales 50% and laid the foundation for seven years of continuous growth.

BIOTRANSPLANT INC. (NOVARTIS funded), Charlestown, MA, 2000--2002

Principal Scientist, (Biotransplant was a Novartis company that developed strategies and products for organ and tissue transplantation and autoimmune diseases in collaboration with Mass. Gen. Hospital & Harvard Medical School.)

Senior scientist, Protein Chemistry 1997 -2000

Managed three scientists; two technicians, and outside CRO staff of seven in contract manufacturing; scale up production of humanized monoclonal antibodies and bio-analytical services. Managed antibody and cytokine productions using large fermenter at production facility under GMP, preparing a validated tech transfer plan & report for pilot production run in collaboration with CROs.

* Upstream processing of monoclonal Antibodies, Cytokines(IL3) and several other proteins using different anion / Cat-ion, Affinity-chromatographic techniques in general, proteins, monoclonal /polyclonal antibody purification in large-scale (gram quantities) for Mass General Hospital

* CGMP manufacturing of APIs, Tech- transfer from one department to another; or one company to another company.

* Fermentation of different Cytokines using Pichia-system (Interleukin-3, Stem Cell Factors, GMSCF)

* Provide leadership for the production team and be a technical resource, SOP writing, Data reviewing, Batch records corrections etc.

* Final report reviewing of several projects signed & submitted to clients (LIMS) or FDA (as desired by clients).

* Training the subordinate staff scientists, and familiarizing of new tech. (s), FDA & ICH guidelines.

* FDA Audits, client interaction, review of protocols, SOPs, final audited Reports and data entry,

Selected Accomplishment

Boosted production. Biotransplant could not produce enough IL3, Stem Cell Factor and GMCSF, supply for Massachusetts General Hospital for Organ Transplants in chimps. Increased the fermentation production of IL3 by 200%. Prepared the Liposomal drug delivery system, enabling Biotransplant to meet the growing needs of Massachusetts General.Hospital.

PHOENIX INTERNATIONAL LIFE SCIENCES, Montreal, Canada 1996 - 1997

Project Manager

Supervised seven scientists, 15 analysts, three report writers, and two data reviewers for several Immuno-clinical sample projects, and ensured FDA compliance of laboratory standards, scheduling, client interaction, QC sample handling, records and data administration; LIMS administration; analytical transfer programs, and specifications management.

* Performed QA CMC writing, reviewed and approved of critical compliance documentation such as validation protocols and reports, analytical protocols, SOPs, completed projects, wrote pre-clinical protocols, validated and audited projects according to GMP and FDA guidelines submission and quality assurance

* Authenticated, accepted and approved raw data, and reviewed study reports for completeness, internal consistency, and compliance with regulatory requirements

Director of Biochemistry & Immunology

Rougier Pharmaceutical & Biotech, Ltd. 1988 - 1996

Rougier was a $27 million, 220-employee Bio=pharmaceutical company.

Recruited to manage all biotech R & D projects and 37 people in the Biotech Division. Controlled a $27 million budget.

Details of duties and accomplishments

Drove growth. Joined Rougier Biotech Division when there were only seven employees. Secured grants including the Canadian Radioisotope license to test many protein drug and cancer drug research. Built a 32-person department that was instrumental in Rougier's purchase by Lalmain Inc. Increased sales 25%.

* Managed the scientific and marketing staff, developing new products such as diagnostic kits and new cardiac drugs that led to clinical trial, phase I, II and IND (Cardio - Vision).

* Worked with several protein purifications to establish and maintain more uniform systems as they relate to Rougier's CRO's and central labs to ensure compliance.

* Actively transferred technology from universities (University of Guelph, Ontario), small biotechnology companies (Mezi Corporation, Daiichi Radioisotope Labs, Japan) in bringing products from scratch through Phase I and II.

* Wrote study reports and synopses from multi center studies for an IND (Cardio -Vision), a new cardiac imaging antibody with 99Tc.

* Purified an anti-cardiac Myosin, Anti-CEA monoclonal and Anti idiotypic monoclonal Antibodies. Used for cardiac imaging studies along with 99Tc in animal models and participated in clinical phase II trials and I.

* Produced three ELISA kits and one Sero-typing Pseudomonas aeruginosa kit that received FDA approval.

* Performed induced-tumor suppression assays in NUDE mice models and implanting silicon capsules in nude mice models for sustained release of bio-molecules.

* Gained practical experience with harvest, centrifugation, microfiltration, DE filtration, tangential flow filtration (TFF); experience with primary and secondary purification (precipitation, chromatography).

* Worked with large-scale API manufacturing facilities under aseptic (Clean room) filling processes and solid state Tablets and capsule manufacturing.

* Supervised nearly 60 antibodies productions, performing QC of new drug screening, downstream processing from small to large fermentor, different types of column chromatography, testing by ELISA, EIA, SDS PAGE, and IEF (double sandwich methods).

Additional Information

Articles Published: 21 articles in major biotechnology journals (complete lists are available)

Speeches Given: 29 conferences, international level (complete lists are available)

Membership: National Membership in Science, Biological Science, Endocrinology Society

Sports and Hobbies: Volleyball, football and chess

EDUCATION

University of Delhi - Delhi, India Ph. D. BIOCHEMISTRY

Banaras Hindu University (BHU) - M.Sc. BIOCHEMISTRY

PUBLICATIONS: 21 papers in reputed journals, i.e. Biochemistry, Mol. Cell. Endocrinology

REFERENCES: Available upon request

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