Research Scientist - Stability Testing Centrenp

Apotex Inc.; Bengaluru; On-site; INR 600,000 - 900,000; Full time

Job summary

Apotex Inc. Bengaluru is seeking a qualified analytical chemist for the ARD-Test Centre. You will perform method validation for drug substance and product, conduct initial and stability testing, and prepare documentation for regulatory submissions as part of a collaborative project team.

The role requires a graduate/ postgraduate degree in Chemistry or Pharmacy, knowledge of wet chemistry, dissolution testing, GC, and strong English communication. Relevant R&D pharma experience is preferred.

Qualifications

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

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 SOPs.
• 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 description

About Apotex Inc.

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.

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. For more information visit: www.apotex.com.

Job Summary

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.