Scientist Analytical Life Cycle Management @ Pfizer

Job Title: Scientist Analytical Life Cycle Management

Job Category: Research

Short Description: This role is responsible for executing Parenteral Drug Product activities at the Synergy Site in Chennai, in compliance with highly regulated GMP standards. The incumbent will perform qualitative and quantitative analyses of organic and inorganic compounds, as well as biologics, to determine their chemical and physical properties during chemical syntheses and drug product development processes. They will also be responsible for validating analytical methods and transferring them to manufacturing sites.

Key Responsibilities:

- Execute error-free analysis, review data in line with applicable site procedures, and deliver on-time results.

- Execution of analytical method development for Parenteral drug products

- Execution of analytical method validation and method transfer

- Participate in project and technical discussions/presentations.

- Ensure the maintenance of equipment, columns, standards, and samples.

- Maintain files and registers with respect to compliance.

- Ensure the destruction of analyzed samples.

- Ensure the compliance of the lab in line with applicable site procedures.

- Maintain training status above 95% in PLA training system and adhere to safety guidelines.

- Provide on-the-job training and qualification for newly joined scientists.

- Provide review comments on new (or) revised procedures.

- Create change requests and action items on Commissioning/Decommissioning of equipment/instruments.

Expectations:

- Technical and functional knowledge to design experiments and independently complete work within own workgroup/project team, working on multiple subprojects in parallel.

- Acts as a technical and scientific resource within own project team/discipline.

- Recognized as a technical expert and competent scientific contributor.

- Works in ambiguous situations within own project team. Moderate uncertainty of successful scientific outcome for some of the solutions attempted.

- Uses own scientific judgment to apply and adapt standard methods and techniques with increased independence by applying prior work experience.

- Identifies and develops scientific activities/projects to support short-term operational goals.

Qualifications:

M. Sc. Chemistry/ Analytical/ M. Pharm. (Pharmaceutical analysis)/ Ph. D with 6 to 10 years of experience in Pharmaceutical Industry

Physical/Mental Requirements:

• Preferably good in numerical ability
• Standing to conduct experiments, observing and online documenting
• Able to work in an oncology lab with all necessary PPEs

Non-Standard Work Schedule, Travel or Environment Requirements:

• Occasionally to work on shifts
• No objection with PPEs while working in an oncology lab.