Job Title
Jr. Research Scientist – Formulation
Job Function
Innovation & Development
Location
Mumbai (Andheri MIDC)
Reporting To
Sr. Group Leader – Formulation
Purpose of the Role
To deliver formulations within defined timelines to meet product delivery goals for Innovation & Development (I&D). This includes developing generic and differentiated generic formulations, ensuring successful stability, and demonstrating scale-up feasibility at the manufacturing site.
Core Responsibilities
Develop formulation prototypes using scientific rationale for excipient selection.
Maintain proper documentation of all trials in logbooks and compile data for Product Development Reports (PDR) for dossier filing.
Apply Quality by Design (QbD) principles for product and process optimization.
Ensure upkeep, calibration, and maintenance of laboratory equipment.
Conduct scale-up studies to ensure successful transition of formulations to engineering batch level.
Key Deliverables
Conduct literature and patent searches to create comprehensive drug profiles.
Perform preformulation studies as required for formulation development.
Develop prototype formulations with rationale-based excipient selection.
Conduct 6-month accelerated stability studies to ensure formulation stability.
Execute proof-of-concept studies to demonstrate bioequivalence (BE) or comparative pharmacokinetics (PK).
Perform scale-up studies at 1/10th scale or engineering batch level.
Support technology transfer and manufacture of bio/clinical batches.
Critical Success Factors
1. Formulation & Product Development
Schedule and execute development activities as per the Quality Target Product Profile (QTPP).
Select suitable polymers/excipients based on functional properties and scientific rationale.
Evaluate Critical Quality Attributes (CQAs) of drug/excipients and assess implications for product development.
Design reproducible, scalable, cost-effective, and environmentally friendly processes with higher yields.
2. Design of Experiments (DOE)
Execute experiments using DOE approaches to optimize product and process parameters.
3. Pharmaceutical Development Report (PDR)
Prepare PDR in alignment with Common Technical Document (CTD) Module 3 requirements.
Ensure compliance with regulatory requirements defined in QTPP.
4. Project Management
Plan, manage, and prioritize multiple projects to meet defined delivery goals within timelines.
Education & Experience
Qualification: M.Pharm / Ph.D. in Pharmaceutics or related discipline.
Experience: 5–7 years of experience in formulation and product development.
Gujarat :
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Frank Scottile Blvd |Missouri :
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Germany | GErmany |Lower Saxony :
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Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
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Carlow |Republic of Ireland :
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Donegal |Meath :
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Dún Laoghaire |Galway :
Galway |County Dublin :
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Beijing |China :
China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
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Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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Nedlands |Queensland :
Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Sheffield |Oxfordshire :
Witney |Ontario :
Uxbridge | Richmond Hill | Australia | Mississauga | Renfrew | North York |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
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Zaventem |South America :
Argentina | Peru |Brazil :
Brazil | Sao paulo |Attica :
Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
New Zealand |Austria :
Austria |Vienna :
Vienna |Catalonia :
Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
Ho Chi Minh City |Italy :
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Oulu |Southwest Finland (Varsinais-Suomi) :
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Green Way | Remote - Europe | Ireland | Thailand | Castlebar | Remote - Middle East | Texas | Nairobi | Bountiful | French | Zaragoza | Belgium | Lousiana | Manipal | Remote - Africa | Lenexa | McFarland | Remote - South America (Latin Americal) | Tulsa | Victoria | Hungary | Medan | Blue Bell | Remote | Leinster | Faridabad | Regulatory Labeling Manager (NA and LATAM Only) | Bishop | Springville | Riga | Hammond | Remote, USA | Slovakia | Switzerland | Melbourne | Xzagreb | Minnesota |Republic of Colombia :
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Brentwood |Bucharest :
Bucharest |Buenos Aires :
Buenos Aires |Republic of Egypt :
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New Mexico | Ciudad de México |Dubai :
Dubai |Makkah :
King Abdullah Economic City | Rabigh | Khulais | Najran | Riyadh | Jeddah |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
Sarajevo |Singapore :
Singapore |Sofia City :
Sofia |Sweden :
Sweden |Taipei :
Taipei |Mazovia :
Warsaw |