Senior Scientist_Drug Product Development

Job description Role & responsibilities

• Planning and execution of Novel and NIF formulation development for liquid/lyophilized protein formulation including Lyophilization cycle development.
• Planning, execution and evaluation of uf/df process for high concentration monoclonal antibody formulation
• Planning Product and process development studies (product contact part compatibility, hold time, freeze thaw, thermal cycling study, agitation study, Photostability study, temperature excursion study, In-use study, reconstitution solution
• ability study, preservative efficacy)
• Planning and execution of Product and process characterization studies, including DoE based ranging study, data evaluation, statistical analysis
• Development of scale down model for drug product manufacturing process
• Preparation of technology transfer document and successful tech transfer to manufacturing unit,
• Evaluation of vendor and planning of outsource studies like Filter validation, extractable leachable study, Preservative efficacy testing, nitrosamine testing, review of protocols, reports.
• Experience on subvisible particles testing using different techniques (MFI, HIAC),
• Functionality method testing - Method development and qualification for Universal testing machine (Break loose glide force, RNS removal force, Safety device activation force, override force etc..)
• Preparation of pharmaceutical development report as per ICH Q8/CTD
• Guiding team for product developmental activities.
• Technical evaluation of Vendor for pen device, auto injectors, prefilled syringe
• Design verification testing planning and functionality testing of Device as per ISO11608 and ISO11040 for pen injector, auto injector and prefilled syringes
• Risk assessment of product contact part, CCS, elemental impurities, nitrosamine impurities in finished product, process evaluation report,
• Preparation of technical documentation design control documents including design history file as per 21 CFR par 820 Preparation of technical file/documentation for NB submission for prefilled syringe and pen (drug device combination product)
• Review of protocols, reports, risk assessment documents, TTD, Change control, MFR, BMR
• Regulatory documents preparation support
• Strong data interpretation and troubleshooting skills
• Sound cross functional communication skills, interpersonal skills
• Accountable for Cross-functional communication with internal and external vendors/clients for technical queries in consultation with reporting manager
• The candidate shall be Accountable for Maintain environment, health, and safety (EHS) requirements at workplace to ensure individual and lab/plant safety

• Knowledge and hands on experience on of MFI method development and qualification
• Knowledge and hands on experience on Functionality test method development and qualification using UTM for
• design verification testing
• Knowledge and hands on experience on Lyophilization cycle development and characterization
• Knowledge and hands on experience on viscometer, density meter, liquid particle counter, benchtop filling
• machine
• Technical abilities to troubleshoots the problems/failures
• Knowledge and hands on experience on JMP software and statistical analysis, Hands on experience on data
• analytics using different statistical tools will be added advantage
• Strong commitment and dedication towards work, enthusiasm, motivation, and persuasive ability in a team and
• experience of leading team of 1-2 members will be added advantage.
• Candidate should able to Work independently, analyse and interpret experimental data, and present/document
• experimental results at meetings.