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Develop safe, robust, scalable, and efficient manufacturing processes for intermediate and Active Pharmaceutical Ingredients (APIs) suitable for both pilot plant and commercial scale production.
Job Responsibility:
Develop safe, robust, scalable, and efficient manufacturing processes for intermediate and Active Pharmaceutical Ingredients (APIs) suitable for both pilot plant and commercial scale production
Performing literature search and identifying various synthetic routes for process development
Promotes the use of novel experimental approaches within sub-function
routinely investigates/creates innovative processes, hypotheses and methodologies
Knowledge of interpretation of structures using spectral techniques like NMR, IR & Mass spectra
Planning and Performing experiments as per process governance (Lab feasibility, Optimization, Pre-validation, CPP and Validation)
Performing What if studies, stress studies, holding time studies, Mass balance, recovery studies and scale up studies
Encountering the process challenges on time and supporting production teams for scale up activities
Handling of business critical / supply chain critical related investigational projects on fast track
Participate in brainstorming activity for the project in identifying scope of improvement
Responsible for making necessary scientific statutory documents for the lab execution of a given project
Designing experiments based on the project /business requirement in varying scale as per the needs
Perform data analysis, interpret the data of them and provide scientific rationale for the experiments
Support the next level manager in providing the cost estimates associated with R&D project proposals
Summarize the experimental results and present to the next level managers for discussion
Prepare Technical project updates with precious data as per the business meeting requirement regularly
Knowledge on ICH guidelines
Co-ordinate with Analytical, Process safety, Process engineering teams on the project discussions and support the need of them to drive the project
Utilization of electronics tools (Biovia eLN, GDMS, LIMS etc.,)
Partner closely with other CRD scientists, Process Engineers, Process Safety Chemists, Crystallization Technologists, Pilot Plant facility, Analytical, Formulation and manufacturing colleagues at Global Pfizer sites as required
Responsible for instrument qualification across the CRD labs (coordination with instrumentation team, quality team)
Ensure compliance with cGMP /GSP procedures and practices
Ensure effective safety systems are implemented in the premises
Perform other tasks as per the dynamic business requirement
Requirements:
Ph.D in the field of Organic Chemistry
Demonstrated capabilities and experience in performing chemical reactions, structure characterizations, basic understanding of chromatography, Crystallizations, Basic safety principles, Basic quality principles, basic understanding of analytical techniques
Experience and demonstrated competencies in working with teams in a matrixed organization, building and nurturing relationships and effective engagement resulting in successful outcomes
Candidate should have skill in preparing the technical reports and adherence to compliance.
Nice to have:
Willingness to learn and apply new technology/ tools to meet process / business needs