Research Scientist - Stability Testing Centrenp

APOTEX; Bengaluru; On-site; INR 900,000 - 1,300,000; Full time

Job summary

APOTEX, a Canadian-based global health company, seeks a Research Scientist for its ARD-Test Centre in Bengaluru. The role focuses on validating analytical testing procedures for drug substances and products, and performing stability, in-process, and raw material testing as per specifications.

The candidate will document results per SOPs and provide technical support to respond to regulatory deficiency letters, while ensuring compliance with quality and safety policies.

Qualifications

• Graduate/postgraduate degree in Chemistry/ Pharmacy from a recognized school/university.
• Knowledge of wet chemistry, analytical bench techniques, Windows-based software.
• Experience in a pharmaceutical R&D lab is required.

Responsibilities

• Performs validation of analytical testing procedures for drug substance and drug product.
• Performs testing of stability samples, in-process and raw materials per specifications.
• Documents and reports results as per SOPs; supports regulatory responses as needed.
• Works safely and collaborates with team to achieve goals.
• Adheres to Global Quality, safety, and compliance policies.

Skills

Wet chemistry

Analytical bench techniques

Windows software

English communication

Education

BSc in Chemistry/Pharmacy

MSc in Chemistry/Pharmacy

Tools

GC

Job description

Research Scientist - Stability Testing Centrenp

Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.

Under guidance of Supervisor or senior chemist, responsible for performing all activities in ARD-Test Centre including method validation for new products, full testing of API, in-process and finished dosages, and generates regulatory submission documentation. Acts as a key member in the project working team.

Job Responsibilities

• Performs validation of analytical testing procedure for drug substance and drug product.
• As per specifications, performs initial testing as well as testing of stability samples, in-process and raw materials.
• Conducts other tests required for dosage submissions.
• Documents and reports results as per established SOP’s.
• Provides technical support to other department in response to deficiency letters from regulatory agencies.
• Works in a safe manner collaborating as a team member to achieve all outcomes.
• Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety, Health and Environment policies, and HR policies.
• Liases at peer levels within R&D solid dosage to obtain a more in-depth level of expertise and to understand their needs.
• Refers more contentious issues, with recommendations, to Supervisor
• Performs all work in accordance with all established regulatory, compliance and safety requirements.
• Ensures all advice given to internal contacts and the complex decisions made at this level are compliant.
• All other relevant duties as assigned.

Job Requirements

• Education
  • A graduate/postgraduate degree in Chemistry/ Pharmacy from a recognized school/university.
• Knowledge, Skills and Abilities
  • Knowledge of wet chemistry, analytical bench techniques, Window-based software.
  • Knowledge of automated data acquisition systems is an asset.
  • Knowledge of Auto/Manual dissolution test is an asset.
  • Working knowledge of GC is an asset.
  • Good written and verbal English communication skills.
• Experience
  • BSc with 5 years or MSc with 3-4 years’ experience in a pharmaceutical lab in an R&D environment.

At Apotex, we are committed to fostering a welcoming andaccessible work environment, where all everyone feels valued, respected, and supported to succeed.

We offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.