Job Category Medical/Healthcare/Bio-Tech
Experience 5.00 to 12.00 years
Education MSc, PHD
Skills and Qualifications: MPharm/M.Sc (5-8 years exp) or PhD (3-5 years exp) with Analytical (Bio)Chemistry background. PhD in Chemistry, Biochemistry, Biophysical Chemistry or Life Science Experience in industry a must. Should have thorough knowledge on analytical method using “state of art” techniques like CE-SDS, MS and HPLC methods working with peptide and protein based biologics. Must have good technical writing and oral communication skills Experience in facing regulatory audits desirable.
Monitor analytical activities and experiments in support of the development, including method development, method validation, method transfer, compatibility studies and stability tests as per EP, USP and ICH guidelines.
Define roles, responsibilities, project scope, timelines and deliverables. Track progress of projects within agreed timelines
Directs Work Instructions for the testing and analysis of Stability .Develop and administer schedules, assign responsibilities within the group
Document all laboratory work to meet regulatory standards and perform data Review.
Stability testing: Protocol design, Long-term stability test, Drug substance stability testing, Comparator stability testing, Formulation evaluation stability testing, data trending, Forced degradation studies,Photostability,Temperature cycling.
Collect, analyze and interpret data, keep records of experiments including results and conclusions, recognize aberrant results and data trends, and provide plausible explanations including plans for follow-up experiments to clarify findings.
Assign and perform training and development goals to the group. Writing and reviewing SOPs.
Achieved deliverables and contributed to meet revenue targets for each quarter.
Preparing proposals and interact closely with project management team.
Successfully initiated and executed stability studies with detail trending and investigation.
Designed experiments and delivered results, demonstrating awareness of customer demands and focus.