Development Management

Ashish Soman, Ph.D.

** ******** ***** *****, *******, Connecticut, CT 06470

Home: 203-***-**** Cell: 860-***-****

E-mail: ***********@*****.***

SUMMARY

Senior technical leader with over 15 years of combined laboratory, staff

and project management experience in pharmaceutical industry. Contribute to

development of multiple investigational and marketed products, adept at

cross-functional communication and project leadership, work staffing,

training, writing technical reports and CMC information to support

regulatory filings, enabling new capabilities for analytical testing, and

demonstrated ability to think strategically and implement plans to meet

corporate objectives

EXPERIENCE:

Boehringer-Ingelheim Pharmaceuticals, Inc., Analytical Development,

Ridgefield, CT

Senior Principal Scientist

2003 - Present

Leadership:

. Provide committed and inspiring CMC leadership team in support

of development of early candidates from SoPD, SOD to Late Stage

and also represented department on R&D Project Teams, striving

for scientific understanding, process knowledge development,

continuous improvement, acceleration, risk assessment and

mitigation, resource allocation and support, as appropriate.

. Promote culture of scientific excellence, multidisciplinary

problem solving, teamwork, consistency, flexibility, execution,

quality and effective communication.

. Encourage new ideas, technologies, processes, and approaches.

. Builds a collaborative, supportive learning environment with a

focus on driving a scientifically-based product development

strategy that is aligned with development and business needs

across the development to commercial continuum.

. Influenced and impacted others through building and maintaining

strong networks that are leveraged to obtain critical

information and accomplish objectives.

Regulatory Experience:

. Develop and implement CMC regulatory strategies as well as

coordinate all aspects of CMC regulatory submissions

. Author documents needed for regulatory submissions (e.g. CMC

sections of IMPD/ IND / NDA, CTA/CTD's and IB's) ensuring the

integration of the scientific, medical, and regulatory input

from development team members.

. Coordinate writing of responses to Health Authority questions

. Knowledge of cGMP's/GLP's, DEA regulations, ICH, FDA CMC

guidance documents

. Working knowledge of a document management system

Technical Experience:

. Direct the overall scientific, technical and laboratory efforts

of the Analytical Development method development groups

responsible for analytical characterizations,

development/validation of analytical methods for excipients,

drug substance and drug product, release and stability testing,

OOS investigations and method transfers to manufacturing sites.

. Manage and oversee assay development and stability programs for

non-clinical, clinical, and commercial stage therapeutics and

establish specifications in support of excipients, API's and

finished dosage forms.

. Collaborate with team members to create and maintain project

plans and timelines, which may include scope of work, staffing,

and target dates and support manufacturing and testing at CROs

. Support CMO's to complete technology transfer and to conduct

stage-appropriate analytical development and validation

activities to enable characterization, release and stability

testing of BI's API, DP and clinical trial materials throughout

development

. Identify analytical science capabilities and technology tools

needed to enable pharmaceutical manufacturing process

development and understanding of development candidates and

their quality and performance attributes.

. Specialize in separation sciences (HPLC/UPLC, SFC, GC, IC, SPE,

IR, Raman and IMS)

. Experience with LC/MS and LC/NMR for structure elucidation and

quantitative analysis

. Collaborate with Discovery, Non-Clinical, Drug Substance and

Drug Product Development groups to define drug candidate physico-

chemical and quality attributes, testing methods, stability

profiles and product performance characteristics

. Participate in due diligence for in licensed products

. Author test procedures, validation/investigation/stability

protocol/reports, SOPs, Business Practices and Process Change

Requests

. Management of personnel including performance appraisals, staff

hiring, and mentoring.

Morton Grove Pharmaceuticals, Inc., Analytical Development, Morton

Grove, IL

Senior Chemist 2000

-2002

. Ensured development of scientifically sound and robust

analytical methods for characterization, testing, release and

stability studies drug product (oral solutions/suspensions)

. Developed and implemented strategies that established

specifications for drug product and provide justification to

internal management and external regulatory agencies

. Overseen tech transfer of analytical methods to CROs and resolve

issues associated with it

. Met timelines and deliverables within budget; and prioritized

resource projects

. Trained R&D personnel on cGMP and GLP. Write

incident/deviation/discrepancy reports.

. Instrumentation: HPLC and GC systems, QuattroMicro-LCMS. HP-UV-

Vis Spectrophotometer, FTIR, Particle Size Analyzer (Malvern),

KF Titrator.

Sunstar Pharmaceuticals Inc. Elgin, IL

Quality Assurance/Research Chemist

1999 - 2000

Provided advanced level of expertise in analytical

chromatographic separations, development and validation of HPLC

test methods for new as well as generic drug products (solid

oral dosage forms); identification of impurities, developed and

implemented cleaning validation protocol.

. Directed the Quality Assurance functions of the company

including release, stability program, document control,

equipment /facility cleaning.

. Failure investigations - Created and implemented new standard

operating procedures when previous protocols failed

. Supervised and guided other chemists in daily management of

analytical lab equipment (calibration, maintenance and

troubleshooting), testing of raw materials by various wet

chemical analyses, stability assays and dissolution testing of

finished products

. Utilized knowledge of cGMP/GLP and formulation of the quality

system within the QA laboratory to initiate ISO-9000 Compliance

. Hands-on experience (operational knowledge) using TRIO 1 mass

spectrometer, GC, GC-MS, UV, IR Agilent and Waters HPLC, DSC,

TGA, IC, CE and polarimeter.

EDUCATION:

Ph.D., Chemistry University of Iowa

M.S., Chemistry University of Arkansas

B.S., Chemistry University of Bombay, India

AFFILIATION:

American Chemical Society

American Association of Pharmaceutical Scientists

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