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Qualifications
- Masters in Analytical Chemistry/Pharmacy/or equivalent
- Min. 10 years’ demonstrated experience in R & D’s analytical process development
- Prior experience in analysis of diverse personal care and dietary supplements, OTC products, animal wellness products is desirable.
- Expertise in handling machines like HPLC, GC, GCMS, ICP_MS etc. and gravimetric analysis
- In depth understanding of analytical practices (e.g., GLP); guidelines (e.g., ICH, WHO, FDA, EU) and exposure to GCC, SASO, IFRA, DSHEA etc. Sound knowledge of global practices and regulatory testing requirements for dietary supplements & OTC products.
- Expertise in Analytical method development, experimental design (DOE), method development and validation using sophisticated equipment (viz. HPLC/MSMS, GC/MS, ICPMS etc.) and knowledge transfer
Skills:
- Proficient in managing technical team as a guiding force with timely training and mentoring teams to meet the immediate project & long-term organizational requirements
- Should have worked with multiethnic, multicultural societies to understand and respect the diversity and accommodate expectations for a global delivery platform
- Problem solving, trouble shooting and investigation and post correction implementation/execution capabilities.
- Should have expertise to manage regular maintenance and upkeep of the lab with minimal downtime and controlled costs.
- Team orientation, “can-do “attitude and ability to deliver breakthrough results
- Ability to set up clear objective and priority-setting
- Knowledge of various digital tools/processes/systems
- Excellent written and oral communication in English
Responsibilities
- Planning, budgeting, and growth of laboratory and people basis organization goals.
· Setting up priorities for sample analysis basis project timelines and other needs thereby accelerating delivery of Dietary supplements, Animal health and Consumer wellness products.
· Supervise, direct, manage, guide the analytical development scientist in the team for successful innovative, quick and accurate delivery of results to the user departments.
· Manage analytical development (wet and instrumental) for its optimal use by spearheading its operations planning, calibrations, maintenance, inventory management, people management and time management.
· Proposing new capacity building keeping in view regulations and global innovations.
· Propose yearly OPEX, CAPEX budgets and manpower and any other resource requirements.
· Guide, direct and supervise team for RM, PM, Intermediate, FG etc. analysis as per project and regulatory requirements.
· Ensuring accurate and quick turn around on reporting using ADL tracker application. the findings.
· Developing in depth analytical principles for product/RM analytical methods and ensuring accurate, reproducible, effective technologies/methods being implemented. Ensure the quality by design in the activities in ADL activities.
· Mapping the literature and regulatory dossiers for identifying prior art and implementing it in analytical process development as needed.
· Developing innovative/new techniques, methodologies for analytical quality controls.
- Design of experiments for specific analytes based on the complexity of the formulation or different matrix
· Delivering quality analytical results to the FD and other teams for further innovations in R & D.
· Work with CFTs for RM, PM, FG and in-process samples, bulk analysis parameter development and specification finalization
- Participate for developing quality evaluation parameters for RM, bulk/intermediates and FG.
· Prepare and participate with R & D-QA for SOPs, STPs, GTPs etc. development.
· validation and preparation of reports, monitoring and ensuring analysis from prototype till stability requirements as per project needs
- Implementation of sound and up to date principles of GLP and other industrial practices in the work environment.
- Participate in investigation teams for deviations and for CAPA.
- Spearhead documentation processes, analytical technology transfer, regulatory support to queries.
- Independently evaluate- analytical practices, limitations and plan risk mitigation plan with FD & R & D-QA teams.
- Work with R& D QA teams for ensuring analytical processes are compliant for prevailing regulations.
- Spearhead analytical technology transfer documentation and deployment to various locations
- Prepare and submit relevant technical documents R &D-QA/regulatory teams.
- Addressing OOS/OOT with the concerned and participate in the root cause analysis and risk mitigation plans. Participate in CAPA implementation with QA as needed.
- Troubleshoot issues related to quality and providing quick solution for minimal business impact.
- Maintaining auditable labs, notebooks and other processes for higher standards of delivery.
- Ensuring analytical development at R & D is up to date as per global regulatory updates.
- Assessing impact of global regulatory updates on the existing portfolio with support from R & D-QA.
- Working with manufacturing QC and site QA for ensuring smooth ADL tech transfer and subsequent improvement & monitoring,
- Participate with operations team for qualification testing labs etc.
- Support operations team for site-to-site transfer as needed.
- Proactive approach for suggesting new machines, technologies, ideas, improvements for betterment.
- Ensuring complete maintenance & safety of man and machine for wet and sophisticated instrumentation laboratories.
