Formulation Scientist

💊 Job Title: Lead Formulation Scientist

📍 Company:

📌 Location:

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About Us

Morepen Proprietary Drug Research Pvt. Ltd. (MPDRPL) is a dynamic pharmaceutical R&D organization committed to developing high-quality, affordable generic and novel products for global markets. With a focus on innovation and regulatory compliance, we work in the area of ANDA, NCEs, 50b2, API development and novel polymorphs.

Job Roles & Responsibilities

• Design and

  development of various dosage forms

  with major emphasize in oral dosage forms for ANDA/NDA submission.

• Build and guide a team

  to ensure on-time product delivery working in internal and external facility
• Ensure execution of

  lab-scale

  and

  pilot-scale batches

  as per QbD and DoE principles.
• Provide guidance to address formulation and process challenges and conduct

  technology transfer

  and ensure manufacturing of exhibit batch and process validation.
• Coordinate with all cross-functional teams including

  Analytical R&D, Regulatory Affairs, QA, Manufacturing

  and

  external parties

  to ensure product delivery.

batch records, protocols, reports, and Module 3 CMC documentation

• Ensure all time

  compliance

  for internal as well as external quality and safety audits.
• Present

  project update and data analytics

  for review with senior management and take Go/No-go decisions
• Internal

  infrastructure building

  as per the scope and budgeting for CAPEX.

• Hiring

  and talent retention. 

Knowledge & Experience

• Ph.D / M.Pharm in

  Pharmaceutics, Pharmaceutical Technology

  , or a related field.
• Experience: Ph.D with 6-8 years and M.Pharm with 8-12 years of experience in the area of formulation developments of

  generic product (ANDA)

  and/or

  Differentiated products (505b2)

  for various markets including US and EU.
• End to end knowledge in

  formulation design, development and filing

  of oral dosage forms (major experience) along with development of other dosage forms.

·       Strong knowledge in Deformulation, Preformulation, Reformulation and Formulation Optimization.

• Sound knowledge of

  FDA/EU/ICH guidelines

  for designing product spec and quality,

  QbD

  ,

  BE studies

  and regulatory expectations for ANDA and/or NDA submissions.
• Strong data interpretation skills and familiarity with

  eCTD Module 3 documentation

  and dossier preparation.
• Ability to

  guide a team

  , fostering a positive work environment, and ensuring on time delivery of products addressing formulation and process challenges.

Preferred Qualifications

• Exposure to

  semi-solid and or complex dosage forms

• Formulation developments of

  NCEs.

• Understanding of bioequivalence study design

  and in-vitro/in-vivo correlation (IVIVC).
• Involvement/participation in

  regulatory audits

  .
• Knowledge of

  analytical techniques

  used in drug product development
• Application of

  digital tools

  in formulation developments

Why Join MPDRPL?

• Be part of an organization driving

  cost-effective global healthcare solutions

  .
• Work on

  end-to-end projects

  from concept to market.
• Collaborate with experts across departments in a

  quality-driven, innovation-centric environment

  .
• Access to

  modern formulation laboratories

  and pilot-scale facilities.
• Competitive compensation with

  performance-linked incentives

  .
• Professional development and

  career advancement opportunities

  .
• Comprehensive employee benefits including

  healthcare and retirement plans

  .

Application Process

To apply, submit your updated CV

jobs@morepenpdr.com

MPDRPL is an equal opportunity employer