Associate Scientist

Lupin; Pune District; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Lupin in Pune, India is seeking an IVIVC-focused scientist to lead pre-formulation studies, physico-chemical characterization, stability assessments and PK analyses for complex generic products. The role applies fundamentals of Pharmaceutical Sciences, Biopharmaceutics, Pharmacokinetics and Biostatistics to design robust generics, with emphasis on BE study design and data-driven formulation decisions.

Candidates with 2–8 years of IVIVC experience or fresh PhDs/MPharm with related training are

Qualifications

• 2–8 years of IVIVC experience in biopharmaceutics or related field.
• Freshers or PhD in related field from tier-1 colleges can be considered.
• Strong knowledge of PK, Biopharmaceutics and Biostatistics.

Responsibilities

• Perform pre-formulation studies, physico-chemical characterization, stability and PK for complex generic product development.
• Apply fundamental understanding of Pharmaceutical Sciences, Biopharmaceutics, Pharmacokinetics & Biostatistics in generic formulation design.
• Perform reconstruction/reverse engineering of innovator formulations and evaluate APIs and in-house formulations using modern analytical techniques.
• Develop discriminatory and bio-relevant dissolution methodologies and validate data to aid formulation variables and BE hit rates.
• Conduct retrospective/prospective biopharmaceutical modeling of in vitro/in vivo data to establish IVIVR and meta-analysis of BE data.

Skills

IVIVC expertise

Biopharmaceutics knowledge

Pharmacokinetics

Statistical analysis

Stakeholder management

Strategic agility

Process excellence

Customer centricity

Developing talent

Education

Doctorate in Pharmaceutical Technology or Biopharmaceutics

Masters in Pharmacy or Biopharmaceutics

Job description

Perform pre-formulation studies, physico-chemical characterization, stability, bioavailability/pharmacokinetics of molecules to aid complex generic product development

Apply fundamental understanding of Pharmaceutical Sciences, Biopharmaceutics, Pharmacokinetics & Biostatistics in generic formulation design.

Perform reconstruction/ reverse engineering of innovator formulation including pre-formulation studies, evaluation of API & in-house formulation using modern analytical, imaging and characterization techniques.

Develop discriminatory and bio-relevant dissolution methodologies, review and validation of data generated from this effort with the objective of providing the formulation team tools that aid in systematic deduction of formulation variables and improving the BE hit rates.

Perform retrospective/ prospective biopharmaceutical modeling of in vitro/in vivo data of complex generics with an objective of establishing IVIVR/C. Dissection and meta-analysis of pilot/ pivotal BE data- Using systematic deduction & statistical approaches

Work Experience

2-8 years of experience in IVIVC and related field

Freshers/ Ph.D in related field from tier-1 colleges can be considered for the same

Education

Doctorate in Pharmaceutical Technology or Biopharmaceutics

Masters in Pharmacy or Biopharmaceutics

Customer Centricity

Developing Talent

Process Excellence

Result Orientation

Stakeholder Management

Strategic Agility

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