The opportunity
Bench scientist with good analytical acumen in the area of formulation research and development, process development, Regulatory and Intellectual property for global markets.
Planning and conducting of experimentation in line with project milestones.
Should have worked on products at different stages from selection to launch with scientific principles of QbD, DoE, statistics and scaleup principles.
Ability to comprehend facts and data from literature reviewed and present the information effectively for decision making.
Understand IP scenario and work on various design around strategies, search prior art, and experimentally establish the proof of concept.
Help identify the challenges associated, bottle necks in development and suggest mitigation proposals during development at various stages.
Co-ordinate with CFTs viz. MS&T, QA, QC and production at different geographies for technology transfer and timely execution of submission batch(es).
Problem solving- identify problem statement, gather facts and to facilitate analysis formulation development, process issues.
Prioritize activities with leads for experimentation in lab. Participate in execution of development trials and during execution of submission batches and further during commercialization.
Align day to day activities in line with established milestones, execution of batches at global TGO operation site.
Clear comminications with internal stakeholders, for identfying challenges/risk areas which would hamper the timely delivery of products.
Align with the BU KPIs and work with group leaders/ leadership teams for implementation of organizational initiatives.
Assist the domain leader in business process evaluation and identifying improvement areas.
Demonstrate personal accountability and effective work habits, viz. working productively & act responsibly, and learn from mistakes.
How you’ll spend your day
Work on bench with the formulation development teams for the timely achievement of key milestones.
Planning and conducting of experimentation in line with QbD paradigm, using OFATs and DOE.
Preparing Presentations during Products development at all stages (Day 0, Development stage, Pilot BE, Scale-up, EB Phase gate, Filling and Launch Phase gate) and discuss/interpret the data.
To conduct literature review, prior art experiment design of the product identified for development.
Evaluate API & Excipients sources and Innovator product identification, procurement, characterization and reverse engineering.
Conduct and interpret data from Preformulation studies viz. Compatibility studies, API particle size finalization (malvern/SEM/Raman), API Solubility studies, polymorphic formphase transformation studies, selection of excipients and process as per strategy.
Conducting and performing the development trial at bench level, problem identification & resolution.
Review and interpretation of analytical data for further action plan.
Responsible for execution of Pilot BE batches and interpretation of bio results.
Responsible for execution of scale-up and exhibit batches at different manufacturing location with coordination of cross functional team and interpretation of Pivotal bio results.
Identify Quality Target Product Profile (QTPP), Critical Quality Attributes (CQAs), Critical Process Attributes (CPAs) and subsequent use of Design of experimentation (DOE).
Establish the stability data for development batches in collaboration with the analytical team.
Master document preparation like MFC, Scale up batch study protocol/ report, sampling plan, stability guidance documents, In-use stability study protocol/ report.
Co-ordination with various CFT’S like sourcing, Project Management, analytical, Regulatory, Packing, Production, MSAT, DQA and clinical for smooth development of product.
Compilation and preparation of pharmaceutical development report with respect to current QbD format.
Responsible for preparation of Product Developmental Report (PDR) for filling.
Handling of deviations, change control and OOS related to Exhibit batches.
Preparation, updating of SOPs.
Maintaining of batch, calibration and other necessary records.
Subjecting required batches to stability studies.
