Associate Manager – R&D | Pfizer | Vizag

Job Description

Purpose of the Job/Role :

As a Scientist, you will be at the center of our operations and you’ll find that everything we do, every day, is in line with an unwavering commitment to quality. With your deep knowledge of the discipline, you will be an active team member who influences the project team level. You will perform qualitative and quantitative analyses of organic, and inorganic compounds, or biologics to determine chemical and physical properties during chemical syntheses, fermentation, or drug product development process.

You will be using your scientific judgment to adapt standard methods and techniques by applying prior work experience and consulting others. Your ability to plan will help in preparing short-term work activities on projects. Your creativity in developing novel processes and new ideas will be used frequently. You will undertake mentoring activities to guide your team members.

Roles and Responsibilities:

• Responsible for executing the end-to-end technology transfer activities of new product introduction of Sterile injectables.
• Maintain a contemporary awareness of Global Business Practices, methods, specifications, Standard Operating Procedures, Pharmacopoeial trends, International Conference on Harmonization guidelines and regulatory expectations.
• Work closely with process experts and project teams to provide timely support for formulators in the form of quality data which can be used in support of regulatory documentation of new drug applications.
• Independently carry out all aspects of practical work necessary to provide right first time results.
• Responsible for performing feasibility studies, MOC studies, dwell time studies and lab scale batches as part of technology transfer activities.
• Responsible for performing Engineering batches, scaleup batches, and Exhibit batches as part of technology transfer activities.
• Attend project team and brainstorming meetings and present data.
• Responsible for providing the required data for regulatory submissions.
• Responsible for process validations of drug product.
• Responsible for QRM preparation & Reviews
• Responsible for CPP establishment and sample size assessment.

Qualifications:

Must-Have

• Bachelor’s Degree
• 8 + years of experience
• Experience with technology transfer activities or formulation development of Sterile injectables.
• Ability to extract relevant information from scientific literature, accurately record observations, facts, data and conclusions during studies or Good Manufacturing Practices {also cGMP} investigations
• Interact effectively with peers and leaders as part of a multi-disciplinary team
• Effective verbal and written communication skills

Nice-to-Have

• Masters degree
• Certified in Problem-solving skills – Yellow belt / Green belt.
• Experience in a {Current} Good Manufacturing Practices {part of GxP} laboratory
• Understanding of various scientific software or software used in pharmaceutical or production environment
• Desire to develop their own technical skill set is essential.