BioProcess development Scientist, biologicals manufacturing operations

CANADIAN CITIZEN

Dr. Subrahmanyam V. Mantha

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

Ph : 944-***-****(India)

PROFILE

Doctorate in Biochemistry possessing an overall experience of 26 years in academia and biotech industry. Vast experience in basic and process research & development involving fermentation and downstream process of vaccines and therapeutics. Hands-on experience of manufacturing operations in cGMP environment. Design and execute research projects in Bio-generics, set up & lead research team and validate methods of development. Managing production, quality control and quality assurance operations as per cGMP norms. Quality control assays and Animal studies for assessing safety, efficacy and potency of potential drug candidates used in interventional studies (diabetes mellitus, atherosclerosis), therapeutic proteins and vaccines. Lead members of a team and provide constant guidance. Regulatory compliance inspections. Review of regulatory documents and handling of internal and external audits. Data interpretation and writing reports. Highly skilled in preparing scientific publications and in scientific presentations. Project management skills. Prepare and evaluate technical proposals, staff supervision, budget preparation, training and development, total laboratory management.. Negotiation skills for procurement of technical equipments.

EDUCATION

• Ph.D. Biochemistry – University of Madras, India – 1986

• M.Phil Biochemistry – University of Madras, India – 1981

• M.Sc. Biochemistry, Andhra University, India- 1979

• Post Graduate Diploma in Project Management, University of Hyderabad, India-2003

• Post Graduate Diploma in Patent Law, NALSAR, Hyderabad, India: 2003

RESEARCH AREAS

Doctoral thesis work

Study to assess the efficacy of herbal drug Gymnema Sylvstre in reducing the development of hyperglycemia and associated changes in enzymes of carbohydrate and lipid metabolism and as well as in the lipid profile in the target tissues of experimentally induced diabetes mellitus in rats

Postdoctoral work

Study to assess the role of oxygen derived free radicals in the progression of Atherosclerosis and Diabetes mellitus (Type 1 and Type 2) in rat and rabbit models respectively.

Process Development

• Vaccines (Hepatitis B, Haemophilus influenzae type b, meningococcal, acellular pertusis, BCG, )

• Therapeutic proteins (recombinant human epidermal growth factor)

EXPERIENCE

INDUSTRIAL

Head, Plant Operations, Green Signal BioPharma Pvt. Ltd., Chennai, India (Dec.2009- )

BCG vaccine manufacturing and research

Supervise the Plant Production Supervisors and to be directly involved and help manage daily Operations, Maintenance, Safety and Quality

Chair review meetings and other internal discussions.

Periodic inspection of facilities, process and testing for quality

Monitor and lead internal audit team

Review in-house documents and those for submission to various regulatory bodies

Review of Regulatory Compliances

Facilitating operational requirements

Head, Process Development, Transgene Biotek Limited, Hyderabad, India (Oct. 2008-Aug.2009)

General Manager, R & D, VINS Bioproducts Limited, Hyderabad, India (June 2007 - Dec 2007)

Setting up laboratory for the process development of therapeutic proteins from snake venoms

Senior Scientific Officer (AGM Cadre) Biological. E. Ltd., Hyderabad, India (Oct. 2003 to June 2007)

Group leader responsible for Development of Haemophilus influenzae type b vaccine:

Lead a group of individuals working on fermentation, purification of polysaccharide, conjugation, purification, formulation and analytical process

Personally handled the process of modification of polysaccharide, its conjugation to protein and purification of conjugate

Partial purification of acellular pertussis for vaccine preparation

Senior Scientist, Bharat Biotech International Limited, Hyderabad, India (Nov.1999- Sept 2003).

Responsible for the development of the process of fermentation, isolation, purification and formulation for recombinant human epidermal growth factor (rhEGF) for therapeutic use.

Established the purification process using Expanded Bed Chromatography

Fermentation, isolation and partial purification of proinsulin by metal affinity chromatography

Developed in-process quality control and release assays in the malaria vaccine (PvRII protein) project in collaboration with ICGEB, New Delhi

PROFESSIONAL SKILLS

Technical

• Conceptualization of projects, Overall Planning and Execution

• Monitoring the progress of the project periodically

• Bacterial vaccine development

• Isolation, purification and characterization of polysaccharides and recombinant proteins from bacterial source

• Preparation of Polysaccharide –protein conjugates and its purification

• Ultrafiltration, diafiltration and sterile filtration processes related to product development using membrane filters

• Extensive experience in the study of disorders (diabetes mellitus and atherosclerosis) in animal models

• Oral and written communication skills

• Computer proficiency in MS Office, Statistics and graphics etc.

• Patent prior art search and drafting

• Preparation and evaluation of technical proposals; budget preparation

• Conducting meetings, seminars and group discussions and data presentation

Management

• Leading a big team of about 30 scientific personnel

• Managing vaccine production unit

• Dealing with operational issues involved in manufacturing and quality

• Train new personnel on the process, equipment operation and maintenance.

• Trouble shooting skills in process and equipment related to the processes.

• Good Knowledge of cGMP and laboratory safety requirements.

• Project management

• Excellent oral and written communication skills

• Planning, execution and overall management of process development and standardization for bacterial vaccines and therapeutics

• Budget preparation for the projects

• Coordination of overall documentation related to product development

• Finalization of technical specifications of Equipments, Chemicals and their validation as per cGMP norms

• Coordination of new lab establishments and coordination of bio-safety norms in the premises.

ACCOMPLISHMENTS

• Instrumental in obtaining DSIR recognition for in house R&D

• Developed the protein- based therapeutics (recombinant human epidermal growth factor.

• Developed the formulation for topical use of rhEGF. Product sold under the brand name as Regen D for the use in diabetic foot ulcers and secondary grade burn injury patients

• Successfully led the team and coordinated technology transfer, process development and planning for scale-up of HiB vaccine

• Recepient of Biomedical Research Grant of Health Services Utilization and Research Commission, Saskatchewan, Canada for the period 1997-1999 for the work on ‘Vitamin E in the retardation of Type II diabetes mellitus’.

• Reviewer of Canadian Diabetes Research Association Biomedical Research grants

FELLOWSHIPS AND AWARDS

University Grants Commission doctoral fellow during doctoral study

Postdoctoral fellow, Dept.of Biochemistry, Univ. of Saskatchewan, Saskatoon, Canada (Received Medical Research Council of Canada fellowship) (Oct.1987 –Sept. 1989)

Postdoctoral fellow, Dept.of Pathology, Univ. of Saskatchewan, Saskatoon, Canada (Received Heart and Stroke of Saskatchewan fellowship) (Oct. 1989 – Jan.1993)

Research Associate, Dept.of Pathology, Univ. of Saskatchewan, Saskatoon, Canada (Nov. 1993 – July 1994)

ACADEMIC

Teaching

• Guest Faculty, University of Hyderabad (July 2008-Nov.2008) Teaching Intellectual Property Rights topics to class of M.Sc. Medical Biotechnology

• Clinical Assistant Professor (Research), Department of Pathology, College of Medicine, University of Saskatchewan, Saskatoon, Saskatchewan, Canada (July 1994 – Jan 1999).

Teaching and as well as training graduate students in their research projects

• Recepient of Biomedical Research Grant of Health Services Utilization and Research

Commission, Saskatchewan, Canada (1997-99)

• Research focussing on type 1 and type 2 diabetes mellitus:antioxidants in retarding the development of the metabolic disorder in animal models

• Assistant Professor, Islamiah College, Vaniyambadi, Tamil Nadu, India (Aug1986- March1987) Teaching undergraduate biochemistry class

Post Doctoral

• Department of Pathology, College of Medicine, University of Saskatchewan, Saskatoon, Saskatchewan, Canada. (Oct 1989 - Feb 1993)

Role of reactive oxygen species and evaluation of antioxidants in the amelioration of

diabetes mellitus and atherosclerosis in animal models

• Research Associate, Manitoba Institute of Cell Biology, University of Manitoba, Canada (Feb.1993 – Sept.1993)

• Department of Biochemistry, College of Medicine, University of Saskatchewan, Saskatoon, Saskatchewan, Canada. (Oct 1987 - Sept 1989).

Glycogen Metabolism in Diabetic Animals, Protein Kinase C, Insulin Receptor.

PUBLICATIONS

Peer reviewed full length Papers: 22

Abstracts of the Proceedings of Conferences and Symposia: 75

Book Chapters: 3

PROFESSIONAL ACTIVITIES

Invited speaker to lecture on Biotechnology topics at:

Vivekananda Degree College, Mehaboobnagar, Osmania University, Andhra Pradesh, India (2009)

Aurora Degree College, Hyderabad, Andhra Pradesh, India (2003)

Department of Biotechnology, JNTU, Hyderabad, India (2002)

Department of Biotechnology, Andhra University, Visakhapatnam, India (2001)

Conferences

Oral and poster presentations of the research findings at National and International Conferences and Symposiums conducted by the following associations

Oxygen Society, USA Chapter

American Diabetes Association

Canadian Diabetes Association

American Association of Clinical Chemists

Canadian Association of Clinical Chemists

Royal College of Physicians and Surgeons of Canada

American College of Angiology

International Society for Heart Research

Keystone Symposia

Indian Association of Biomedical Scientists

International Conference on Innovation and Intellectual Property (IPR) Strategy

WORKSHOPS, SYMPOSIAS AND TRAINING

• Nederland Vaccine Institute, Netherlands for the process development of Haemophilus Influenzae type b vaccine. (July 2004)

• International Centre for Genetic Engineering and Biotechnology for the development of in-process quality control and release assays in the malaria vaccine project (April 2002)

• Liquid Chromatography School conducted by Waters Corporation (April 2006)

• International Training and Research in Emerging Infectious Diseases Asian Regional Workshop on Intracellular Pathogens (Dec.1999)

• South Asian Society on Atherosclerosis and Thrombosis symposium on Atherosclerosis, Thrombosis, Haemostasis and Transfusion Medicine (Dec. 1996)

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