Manager/ Sr. Manager– Formulation Development

UMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations i.e., Injectables, Tablets, Capsules, Suspensions, Dry Syrups, etc. UMEDICA's manufacturing facility, located in Vapi (Gujarat), is approved by global regulatory.

UMEDICA was founded in 1983 and has business operations in more than 85 countries including EU, UK, USA, Canada, Australia, Middle East, Central & South American countries, Africa, Asia & CIS countries.

We at UMEDICA strive to achieve more through a culture of innovation & continuous improvement.

Manager/ Sr. Manager– Formulation Development

This position is based at our R&D Centre at Turbe and will report to GM Formulation Development.

The remuneration package will be commensurate with the incumbent’s professional experience and in line with market standards.

Key Responsibilities:

• At least 8 years’ experience in formulation and development for oral liquid dosage form for with US & EU
• Should have done active contribution in liquid products development which includes identification of excipients, prototype formulation based in innovator product characterization
• Identification of right primary packaging components. Initiate stability batches with generating required GxP documents
• Candidate should have detailed understanding of scale up and EB manufacturing
• Should independently monitor and prepare formulation development documents like development report, MFC, specifications, tech transfer documents.
• Candidate should support for attending regulatory queries for US & EU market
• Should have in depth knowledge regarding excipients, its function and usage

Other responsibilities:

• To execute product development activity as per requirements GMP need
• Support for scale up and EB batch activities
• Maintain laboratory environment as per GXP need, prepare SOP and develop systems
• In-depth understanding of regulatory agency requirements
• Should in-dependently handle plant pears

Required Skills & Competencies:

• Technical expertise

  in Oral Liquid formulation
• Strong understanding of

  regulatory requirements

  : FDA, EMA, ICH guidelines, QbD, BCS-based biowaivers.
• Knowledge of

  intellectual property (IP)

  considerations in formulation design (FTF, PIV).
• Hands-on experience with formulation equipment and scale-up (granulators, compression, encapsulation, coating).
• Proficiency in data interpretation, scientific writing, and regulatory documentation.

Qualifications & Experience:

• M.Pharm in

  Pharmaceutics

  ,

  Pharmaceutical Sciences

  , or related field.
• 8 to 12 years of experience in

  formulation development of oral liquid dosage forms

  .
• Proven track record in

  technology transfer

  , global regulatory filings, and team leadership.