R&D Analytical Officer

JOB DESCRIPTION

SUMMARY OF ROLE

• R&D Analytical Officer - Selfcare working across various NPD Projects.
• Responsible for but not limited to alternate RM vendors qualification, analytical method development, analytical method transfer and analytical method validation. Stability testing and review and approval of analytical and chromatographic data for non-commercial product release for various NPD projects.
• Writing analytical method development, analytical method transfer and analytical method validation, stability protocols, reports, other scientific justification documents and conducting stability studies and laboratory work including interpretation and reporting of results for projects as required.
• Hands on skill for Analytical method development & validations on HPLC/UPLC, GC, Dissolution, UV, IR, KF, Empower (CDS), Viscometer, ICP-MS/OES, Malvern particle sizer other ancillary instruments.
• Role is based in Gurgaon, India. Person will report to R&D Senior Analytical Associate, also be expected to be self-starting as well as able to work within strong team.
• Role required travel to EMO/outsourcing labs as well.

RESPONSIBILITIES

Functional

• Utilize technical expertise to develop new analytical methods and method validations.
• Partner with key functions – Quality, supply, regulatory, Medical to define and uphold product quality standards and continuously improve to achieve "right first time" practice in working area by following documented procedures and good documentation practice.
• To support, stability studies and method development and method validation for the various NPD Projects, manufacturing/analysis of lab samples for evaluation, etc.
• Responsible for test method preparation/updating (RM & FG) as and when required.
• Responsible to guide new joiners during experimental and laboratory work.
• To support the outsourcing of analytical activities for R&D Category Selfcare projects.
• To maintain EHS standards as per site policy.
• Working on QMS tools and SAP to support the R&D Category Selfcare projects.
• To be responsible for calibration of laboratory instruments, working standard qualification and another lab support as when required.
• To be responsible for enabling compliance in shared lab.
• To be responsible for the maintenance of laboratory equipment, working space, lab consumables and inventory and ensure with other colleagues, that the required safety measures are in place.
• To be flexible and positive to the changes in priorities at short notice. Need to take part in team meetings to report on project progress and contribute positively to problem solving.
• Calibration of various instruments and working standard preparation as and when required.
• To be flexible for travel across various EMO & outsourcing labs for analytical method development, analytical method transfer and analytical method validation. Stability testing and review and approval of analytical and chromatographic data

Cross Functional

• To liaise with regulatory team on projects as required.
• To liaise with supply, QA, QC, RA and Supply Technical as required for projects.

Others

Good communication and written skills in Business (English) language and good presentation and decision-making skills.

EXPERIENCE/QUALIFICATION

• Minimum 3+ years of experience in Analytical research & development for Drug and Ayurvedic formulation like - Solid, Semisolid and Liquid oral & Topical.
• Minimum M. Pharmacy/M.Sc. in Analytical chemistry