Senior Research Scientist - Analytical Research & Development

Role Overview:

You will be responsible at project level for all activities in AR&D-Test Centre under the guidance of Supervisor. Your main tasks will include method validation for new products, testing of PI, in-process, stability samples, and finished dosages. Additionally, you will be generating regulatory submission documentation. As a key member of the project working team, you will provide support to junior chemists and oversee lab activities in the absence of the Asst. Manager.

Key Responsibilities:

• Perform validation of analytical testing procedures for drug substance and drug product
• Ensure analytical methods validation is conducted according to approved validation protocol with accuracy and precision
• Conduct routine tests for drug substance release, drug product release, stability samples, and in-process samples
• Conduct lab investigations for OOS and OOT results
• Perform other tests required for regulatory submissions
• Guide junior chemists in complex testing and investigation
• Document and report results as per established SOPs
• Provide technical support to other departments in response to deficiency letters from regulatory agencies
• Work collaboratively in a safe manner to achieve all outcomes
• Demonstrate organizational values: Collaboration, Courage, Perseverance, and Passion
• Ensure personal adherence to compliance programs including Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety, Health, and Environment policies, and HR policies
• Develop and manage strong relationships with internal customers
• Liaise at peer levels within R&D solid dosage to obtain a more in-depth level of expertise and understand their needs
• Refer contentious issues, with recommendations, to Supervisor
• Perform trouble-shooting on complex issues with guidance from Supervisor
• Oversee the resolution of more complex issues related to the project
• Perform all other relevant duties as assigned

Qualification Required:

• A graduate/postgraduate degree in Chemistry/Pharmacy from a recognized school/university
• Sound working and theoretical knowledge of chromatographic systems
• Knowledge of UV, IR, wet chemistry, potentiometric titration, analytical bench techniques, Window-based software, and automated data acquisition systems
• Knowledge in HPLC method development and method validation
• Excellent written and verbal English communication skills
• Leadership skills are an asset
• Experience: BSc with 5 years, or MSc with 4 years, or PhD with 2 years experience in a pharmaceutical lab in an R&D environment

(Note: Any additional details of the company were not present in the provided job description) Role Overview:

You will be responsible at project level for all activities in AR&D-Test Centre under the guidance of Supervisor. Your main tasks will include method validation for new products, testing of PI, in-process, stability samples, and finished dosages. Additionally, you will be generating regulatory submission documentation. As a key member of the project working team, you will provide support to junior chemists and oversee lab activities in the absence of the Asst. Manager.

Key Responsibilities:

• Perform validation of analytical testing procedures for drug substance and drug product
• Ensure analytical methods validation is conducted according to approved validation protocol with accuracy and precision
• Conduct routine tests for drug substance release, drug product release, stability samples, and in-process samples
• Conduct lab investigations for OOS and OOT results
• Perform other tests required for regulatory submissions
• Guide junior chemists in complex testing and investigation
• Document and report results as per established SOPs
• Provide technical support to other departments in response to deficiency letters from regulatory agencies
• Work collaboratively in a safe manner to achieve all outcomes
• Demonstrate organizational values: Collaboration, Courage, Perseverance, and Passion
• Ensure personal adherence to compliance programs including Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety, Health, and Environment policies, and HR policies
• Develop and manage strong relationships with internal customers
• Liaise at peer levels within R&D solid dosage to obtain a more in-depth level of expertise and understand their needs
• Refer contentious issues, with recommendations, to Supervisor
• Perform trouble-shooting on complex issues with guidance from Supervisor
• Oversee the resolution of more complex issues related to the project
• Perform all other relevant duties as assigned

Qualification Required:

• A graduate/postgraduate degree in Chemistry/Pharmacy from a recognized school/university
• Sound working and theoretical knowledge of chromatographic systems
• Knowledge of UV, IR, wet chemistry, potentiometric titration, analytical bench techniques, Window-based software, and automated data acquisi