Qualification & experience :

• Minimum M.Sc. / M. Pharm with 8 to 15 years of experience in Analytical R&D

Key Accountabilities and Responsibilities:

· Analytical Method Development of various pharmaceutical dosage forms like oral solid, oral liquid, Injectables, Nasal Spray.

· Analytical Method Validation of various pharmaceutical dosage forms like oral solid, oral liquid, Injectables, Nasal Spray.

· Analytical Method Transfer of various pharmaceutical dosage forms like oral solid, oral liquid, Injectables, Nasal Spray.

Key Deliverables:

· Analytical method development, validation and transfer of method for pharmaceutical dosage forms (like oral solid, oral liquid, Injectables, Nasal Spray) as per the regulatory requirements.

JOB SPECIFICATION

• Analytical method development and validation for pharmaceutical dosage forms.

• Literature search related to the drug substance, create analytical profiles.

• Execution of analytical method transfer for pharmaceutical dosage forms.

• Analysis of routine samples (product development batches, stability study samples, raw materials etc.).

• Operation and Calibration of analytical instruments/equipment’s.

• Qualification of working standards.

• Data Review and Release (as assigned).

• Documentation of analytical activities as per Good documentation practices.

• Work in laboratory as per Good laboratory practices.

• To use PPEs and follow safe practices in lab.

• Preparation of SOPs, STPs, Specifications, COAs and stability reports

• Preparation of RM Specification and STPs

• Trouble shooting of analytical issues/problems/queries.

• Review of Analytical development & stability data.

• Analytical Activities related to Quality Control Department.

• Any other task assigned by management.

Competencies Required:

• Good Knowledge about Analytical Method development, Validation and method transfer

• Knowledge about the Regulatory requirement and Quality requirement

• Must be able to perform the analysis as per the Good Laboratory Practices

Functional Skills/ Know-how:

• Hands on experience on HPLC, GC, UV spectrophotometer, IR spectroscopy, Dissolution Test Apparatus, Disintegration Test Apparatus, Viscometer, Differential Scanning Calorimetry (DSC), Malvern Particle sizer.

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com