Senior Research Scientist

JOB DESCRIPTION:

• Analytical method development and validation for all pharmaceutical dosage forms as per current compendial pharmacopoeias, ICH, global regulatory requirements.
• Execution of analytical method transfer for pharmaceutical dosage forms.
• Providing technical support to Abbott manufacturing facilities and Third-Party Manufacturers (TPM' s) across globe.
• Collaboration & participate meetings with multidisciplinary teams (Manufacturing, Supply Chain, Commercial, Quality Assurance and Regulatory Affairs) to provide scientific support to Product Evaluation, Formulation and Process Development.
• Literature search related to the drug substance, create analytical profiles.
• Analysis of routine samples (product development batches, stability study samples, raw materials etc.).
• Operation and Calibration of analytical instruments/equipment’s.
• Conducts lab investigations for OOS and OOT results
• Data Review and Release (as assigned).
• Documentation of analytical activities as per Good documentation practices.
• Preparation of SOPs, STPs, Specifications, COAs and stability reports
• Review of Analytical development & stability data.
• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
• All other relevant duties as assigned.

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)