Dear Candidate,
We have an Urgent Opening for Senior Head Principal Scientist – Formulation Development
Industry : Pharma Formulation
Requirements:
a) Minimum 15 years of experience in Formulation Development for OSD & Semi Solids
b) Work Exposure to regulated markets & their audit
c) Should be qualified as M.pharm / Ph D
d) Should be able to handle & lead a team of Research Scientist
Job Profile :
1) Responsible to handle day-to-day activities with F&D team for smooth and productive functioning
2) Responsible for formulation development activities along with troubleshooting in commercial products (wherever required)
3) Should have thorough understanding and on-hand experience in Formulation Development, Process Development, Process Optimization, Process Validation, Process Scale-up, Technology transfer, and Stability Studies as per EU-GMP or PIC/s requirements, for OSD (Tablets, Capsules), Oral Powders, External Semi-solid products (Cream, Gel, Ointment etc.), including conventional, modified and novel drug delivery techniques
4) Should have strong knowledge for process selection, excipient selection, compatibility studies, forced degradation studies etc. along with Quality-by-design approach
5) Should have thorough knowledge of Pharmaceutics, Organic Chemistry and Analytical Chemistry required for Formulation development and trouble-shooting.
6) Should have understanding of impurity profiling, dissolution profiling and stability studies of formulations for regulated and semi-regulated markets
7) Should possess sound knowledge about the safety aspects, cGxP and cGMP, qualification of equipment and instruments
8) Should have strong capabilities to identify the problems and to develop feasible remedies in timely manner
9) Should be well conversant with literature survey, scientific research forums for needful intellectual inputs
10) Should possess thorough operational knowledge of machines like granulation, compression, coating, packing, ointment mfg., powder filling etc. and other novel technologies
11) Essential to have some exposure to regulatory audits like US-FDA, MCC-South Africa, MHRA-UK, TGA-Australia, ANVISA-Brazil, Eu-GMP or PIC/s etc
12) Strong knowledge for on-going updates/developments in Research and Development, pharmacopoeial updates, and inclination to adopt most suited and feasible processes and methodologies / updates for upgrading the existing formulations
13) Should have strong knowledge of preparation, review and updation of documents including, SOP, Product Development Report, RM / FG / IPQC Specifications, Master Mfg. Document, Master Packing Document, Batch Manufacturing Record, Batch Packing Record, Technology Transfer documentation etc.
14) Should have understanding of 21 CFR and data integrity during product development.
To apply revert back on the same mail id with your Resume / CV on cv@bestselectservices.net
Along with the below details :
a) Current Salary :
b) Reason of Leaving :
c) Notice Period :
d) Current Location :
Regards,
Team Recruitment