Develop scalable manufacturing processes for APIs, conduct experiments, analyze data, ensure compliance, and coordinate with various teams for project success.
Job Description
QUALIFICATION
Work Location Assignment: On Premise
Work Location Assignment: On Premise
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Research and Development
- 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.
- Willingness to learn and apply new technology/ tools to meet process / business needs
- 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
QUALIFICATION
- 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.
Work Location Assignment: On Premise
Work Location Assignment: On Premise
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Research and Development
Top Skills
Biovia Eln
Gdms
Ir
Lims
Mass Spectra
Nmr
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