Job Description

Perform Product Evaluation which includes extensive literature search, scientific understanding extracted from different sources and application of concepts in complex novel drug delivery system. Evaluate and collate literature on API, reference product, pharmacokinetic parameters, business rationale etc. to shortlist product for discussion to help strategies the course for development with anticipated challenges and mitigation plan. Participate in cross-functional team s discussion including RA, IP, Bio, API, strategic sourcing, portfolio management in the planning, analysis and evaluation of product development options in 505(b)(2) product development. Strategy design Concept creation and justification with respect to reference product and the rationale behind the introduction Perform pre-formulation, feasibility trial to till Proof-of-concept at small scale and later to large scale manufacturing. Understanding of nucleic acid biochemistry to justify the selection of nucleic acid API in target physiology, solution state stability of nucleic acids. Perform selection of composition to achieve desired TPP, selection of nucleic acid API, strategies to overcome stability in solution, formation of ionic complexes of nucleic acid, Plan and conduct the scheme of experiments including formulation preparation and selection of excipients to stabilize nucleic acids. Perform and lead characterization for low molecular weight impurities, aggregates, by gel permeation chromatography. Creation of formulation strategies in collaboration with HPT and IP. Preparation of DSN, Risk registry and QBD (CQA and QTPP) documents. Perform stability studies as per ICH requirements, prepare justification of specification for developed product Conducting the strategy and Risk registry discussions with all the CFTs- RA, IP, Bio, CPPK, Packaging, HPT (Analytical and Formulation) and API team (only for internal API) Process development studies, scale up and exhibit batches execution at plant. Use of digital tools in formulation development and optimization. Preparation of pre-IND meeting drafts for correspondence with FDA. Understanding of pre-clinical studies required for 505(b)(2) product development, safety studies and PK studies. Capability Building exercise- New Technologies/Tools \'Capability building for vertical which includes identification and implementation opportunity, followed by rationale establishment - Literature search and Concept evaluation note; Selection of best possible technology with demonstration on actual projects. IN ORDER TO leverage/introduce new technologies into product development\' Qualifications, Experience, Skills & Attributes : M-Pharm with 6-8 years of experience. / PhD with 3-4 year of experience Nucleic acid product development; Knowledge on regulatory guidance; complex drug product development Should have experience with product Scale up and Technology transfer and regulatory filing in US/EU market. Excellent problem-solving skills, attention to detail, and the ability to work independently and within a team. Effective communication skills, both written and verbal, for presenting results and collaborating with colleagues.

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