Job Description

Primary Job Function :

The Manager Biopharmaceutics within Global Preclinical & Product Safety in Abbott Established Pharmaceutical Division (EPD) will provide scientific support in biopharmaceutics and pharmacokinetics to multi-disciplinary project teams for new product ideation, formulation development and biostudies that enable process and product development. The job collaborates with global/regional cross-functional teams to ensure adequate and timely support to all EPD Established Pharmaceutical projects.

Core Job Responsibilities:

• Work with product development, clinical, regulatory and any other cross-functional teams to support product innovation and development
• Provide inputs to formulation and analytical teams to identify product specific Bio-relevant/Bio-discriminatory media
• Identify in-vitro characterization tools and methodologies relevant to the in-vivo behavior of the formulations to select appropriate formulation strategies
• Evaluate data from biostudies to identify critical parameters (CMA, CFC, CPP) to enhance success in bioequivalence studies
• Perform mechanistic Modelling & Simulation to simulate the in vitro dissolution of active pharmaceutical ingredients (API) and formulation excipients under various experimental conditions and predict the in vivo pharmacokinetic profile
• Build and validate IVIVC/IVIVR for products when feasible
• Monitor and plan external development activities as required
• Search, compile and interpret scientific data, write reports, regulatory documents, manuscripts, and present work at internal and/or external meetings

Supervisory/Management Responsibilities:

• Can represent GPPS within project teams.
• Maintains relationships and can work with Contract Research Organizations (CROs).

Position Accountability/Scope:

• Reports to the Head-DMPK within GPPS.

Minimum Education:

• Masters in Pharmaceutical Science or a post-graduate degree in a related scientific discipline with a 7+ years’ relevant experience in the pharmaceutical industry.

Minimum Experience/Training Required:

• In-depth knowledge of biopharmaceutics and ADME principles and underlying mechanisms
• Thorough understanding of the impact of various factors (e.g., dosage forms, excipients, routes of administration, dosing regimens and physiological variables) on clinical outcomes
• Relevant hands-on experience in modelling and using software like DDDPlus, GastroPlus, Phoenix WinNonlin, Graph Pad Prism etc.
• Understanding of regulatory requirement of Biopharmaceutics and Bioequivalence for US, EU, and Emerging markets for generic products
• Sound knowledge on pharmaceutical development from drug discovery to marketing authorization and product life cycle
• Excellent interpersonal and verbal/written communication skills
• Highly motivated and a proactive team player
• Proven ability to effectively work in complex and multifunctional teams

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Product Development

DIVISION:

EPD Established Pharma

LOCATION:

India > Mumbai : BKC Building

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Not specified

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)