ABHISHEK UPADHYAY
+91-922-983-4997
upadhyayabhishek660@gm
ail.com
263- Rachna Nagar
Delhi
EDUCATIO N
M. Pharmacy 2008 - 2010
Rajiv Gandhi Proudyogiki
Vishwavidyalaya
GOAL
As a Pharmaceutical Researchers,
my goal is to increase the visibility
and awareness of my company’s
pharmaceutical and medical
products and maximize growth.
KEY S K I L LS
Microsoft Office Suite
Financial Forecasting
Business Professional Stats
Database Management
Team Leadership
Conflict Resolution
ACHIE VEM ENT
100% achievement in 2009 and
95 % achievement in 2010-
Cadila Pharmaceutical
Successfully Launched 5 BVOs
- Pfizer
Sr Manger R&D
CAR EER O B JECT IVE
As Pharmaceutical Development Project Leader, responsible for the
development of a pharmaceutical product, GMP Documents from its theoretical
design, pre-formulation, formulation, scaling, and manufacturing of pilot
batches under current regulations. Actively involved in the preparation of drug
product development reports for the CMC section of IND/IMPD or NDA/MAA
submissions.
SKILLS and QUALITIES
• Experienced in leading new product development projects.
• Experienced in designing formulation and prototyping for commercial or
consumer needs, SOPs/ MFR etc. approver.
• Experienced working in diverse and cross-functional teams. Proficiency in
applying QbD principles for new product development formulation and process
development. Responsible for maintaining GMP environment.
• Proficiency in formulating with global drug requirements for new and modified-
release drug products. Proficiency with DoE by demonstrating successful
application for optimizing formulation and process parameters.
PROFESSIONAL EXPERIENCE
R&D Sr MANAGER since May 2017 to – Present
Eris Lifesciences, New Delhi
• Lead and manage a team and participate in formulation design strategies for
complex, differentiated, 503A and 503B, 505b (2) and generic ANDAs, within
areas of expertise to address specific technical requirements of a project.
• Manage resource planning and ensure the availability as per requirements on
timely manner. SME for Raw Material sourcing and approval.
• Prioritization of projects based on allotted annual budget.
• Strategic scientific thinking and prepare feasibility platform technology planning
for development of ANDA, 505(b)(2) & complex injectables products to increase
innovative product portfolio.
• Evaluate results relative to product requirements, definitions and/or program
goals. Perform stability data trend reviews for stability studies in support of new
product development or product changes.
• Builds effective relationship with CFT customers.
• Responsible for formulation development of new concepts from
conceptualization, development, to transfer of products.
• Play a lead role in resolution of the challenges faced during product transfer of
new products from R&D to Manufacturing site.
• Responsible for availability of required instrument/equipment in formulation
development department for product development.
• Provide solutions and or suggest on development related issues.
• Review plan, coordinate and manage laboratory activities in coordination with
team members.
• Review project budget and schedule, proposals by collaborating with other
stake holders.
• Play a lead role in support to plant site during audit.
• Responsible for all remediation related activities.

Personal Details
Date of Birth : 08 January 1987.
Nationality : Indian
Marital status : Married. Language
proficiency:
English & Hindi
EXTRA C U R R I C U L A R
ACTIVITI ES
➢ Member of event organization
committee in school and
college.
➢ Member of Indian railway
emergency/ disaster response
circle.
➢ Compliance/mitigation of
HAZID, E&C, Data integrity,
training & GLP in F&D
department.
➢ Understand all SOP’s applicable
to R&D and ensure to follow
the processes/Practices as per
defined SOP’s.
➢ Support management in
concluding Quality inspections,
GMP deficiencies response.
• support the regulatory for filing and query responses. Ensure timely closure
of QMS elements (CCN/CAPA/NCR/SNCR).
• Read and understand all SOP’s applicable to R&D and ensure to follow the
processes/Practices as per defined SOP’s.
SENIOR SCIENTIST, FORMULATION DEVELOPMENT
since 2014 to – 2017
Cadila pharmaceutical, Location Ahmedabad.
• Conducted formulation and process development for internal and client-
sponsored programs. Scale processes from benchtop to GMP manufacturing
equipment for clinical trial material production. Contribute to the
development of innovative drug delivery technology and patents.
• Applied knowledge of pre-formulation studies and physicochemical data
needed to support formulation development.
• Worked with members of Formulation Development and Manufacturing to
prepare technical and clinical batches of products. Activities may include:
conduct formulation development and process optimization studies, prepare
batch records, conduct batch manufacturing and complete batch
documentation as required.
• Worked with Analytical Development, Manufacturing, QC, QA and other
groups to ensure project requirements are met.
• Resolved technical issues and make recommendations for various options
that would solve the issue, including the preferred option.
• Worked independently but collaboratively. Recognize key issues likely to
affect successful and/or timely completion of work and bring them to the
attention of the supervisor. Write technical reports.
• Executed technical activities involving active pharmaceutical ingredients that
may be potent or hazardous while following appropriate safety procedures.
TECHNICAL SERVICE OFFICER since 2011 - 2014
PFIZER LTD, Location Hyderabad.
• Ensure execution of formulation development.
• Manage a portfolio of formulation development projects
• Manage identification of formulation development strategy for assigned
projects. Assist in developing and communicating timelines and costs for
formulation development projects.
• Identify and escalating risks to technical sub-team and core project team.
Execute laboratory development activities.
• Coordinate external development activities (as required) by providing
technical leadership and accountability for delivering timing commitments.
• Assist in presenting sub-team recommendations, conclusions, and challenges
to technical leads;
• Develop and/or co-author technical documentation to support the launch
and regulatory approval of projects. Ensure formulation reports are written
and approved.Propose formulations consistent with business priorities.
• Work with analytical development to determine experimental and stability
test requirements.
• Contribute to innovation. Participate in ideations based on category
innovation strategy or consumer insights. Attend product research to
understand consumer feedback on the new products; Make prototypes
against new product ideas.