16 July, 2022
Dr Reddy’s Hiring Formulation Scientist – Liposomes
Technical due deligence (TDD) for Product selection
- “Perform Product Evaluation which includes extensive literature search, scientific understanding extracted from different sources and application of concepts in dosage form design and development.
- Evaluate and collate literature on API, reference product, pharmacokinetic parameters, business rationale etc. to shortlist product for discussion to help strategise 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 the generic market for developed markets
- IN ORDER TO prepare detailed technical assessment -pack (PSN, Summary document, Check list and Summary slides for the products shortlisted for tabling in Pre-apex and Apex.- 12-15 Products/Year
- “Perform Product Evaluation which includes extensive literature search, scientific understanding extracted from different sources and application of concepts in dosage form design and development. Also perform analysis on API, reference product, pharmacokinetic parameters, etc. for to-be-introduced products
- Concept creation for EDF products by anticipating reference product and the rationale behind the introduction
- Plan and conduct the scheme of experiments.
- Perform pre-formulation related activities such as excipient compatibility studies on need basis
- Design dosage form to study the API and excipients interaction on stability and under different processing conditions.
- Perform physicochemical characterization of drug substance.(Bulk properties, Solubility studies, PSD, XRD, DSC,TGA of API)
- Evaluation of physico (XRD, IDR) , chemical stability of alternate polymorphic form/amorphous form in comparison to Innovator form.
- Perform pre-formulation related activities such as Drug- excipient compatibility studies on need basis
- Process and solvent induced solid state transformation studies
- Drug-excipient compatibility studies on need basis
- Prepare dosage form to study the API and excipient’s interaction on stability and under different processing conditions on need basis.
- 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)
- Creation of formulation strategies in collaboration with HPT and IP.
- Preparation of DSN, Risk registry and QBD (CQA and QTPP) documents.
- Extending support to HPT while transferring the product to explain the product, strategies, critical aspects, risk involved etc.
- IN ORDER TO ensure the readiness of the strategy design for HPT for Introduction, for faster execution on the co-created strategy.
Full kit readiness -Logistics-4-5 Products/Year
- “Preparation of NPI report
- Request for ELN folder creation
- Material code creation request for API and new excipients
- Application for Test lic, RLD import lic , API import lic (On need basis)
- Procurement of API and RLD required for inititation of development
- Arranging for free samples of new excipients identified as part of strategy
- API quantity calculation sheet till EB
- IN ORDER TO complete fullkit activities before the product is introduced to development team
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”
- Comprehensive knowledge of formulation development of Injectable/Ophthalmic formulation.
- Should have experience with product Scale up and Technology transfer and regulatory filing in US/EU market. Should have good communication & coordination skills.
Education & Experience:
· M-Pharm with 3-7 years of experience