Analytical Development Head - Pharma

General requirements:

- Strong experience in analytical method development, analytical method validation and stability of herbal extracts, pharmaceutical ingredients, excipients, pharmaceutical products (tablets, capsules, syrup, powders, ointments, gel, lotion etc.) consumer products (cleansing products like face wash, shampoo, soaps and stay on products like creams, lotions, gels, serum, etc), animal health products (bolus, powders, spray, liquids etc.) and functional foods (powders, gummies, beverages, nutritional bars etc.).

- Should be aware of regulatory requirements of herbal products, consumer products, animal health products and functional products domestic (Ayush, BIS, FSSAI etc.) and global markets (DSHEA, EMEA, RUMEA, APAC etc and ICH stability guidelines etc.

- Should be well aware of the documentation and submission of CTD dossiers, Stability protocol, Stability data reports, Analytical method transfer, Analytical specification, etc.

- Should be aware to ensure overall GLP compliance of the lab with respect to SOPs, Instrument calibrations and maintenance (AMC and CMC).

- Coordination and support for ISO and other regulatory audits of R&D.

- Good networking and Collaboration with external agencies like United States Pharmacopoeia, Department of AYUSH, academic institutions and testing labs for scientific contribution and project collaboration.

- Good communication and interpersonal skills

- Good networking with suppliers, regulatory bodies and academic institutions.

- Strong work ethics and discipline

- Ability to identify and define the problems

- To be able to extract crucial information from the data and strong interpretation skills

- To be able to provide workable solutions to the identified problems.

- Technical

- To be responsible for departmental activities covering method development, method validation, stability studies, method transfer activities for herbal ingredients, extracts and finished dosage forms of Pharma Products, Animal Health products and Functional Foods.

- To be responsible for approval of Specifications for raw materials, excipients, finished products and related Standard Test Procedures (STPs), General Test Procedures(GTPs).

- To coordinate cross functional teams for qualification of alternate vendors related to extracts and excipients in association with Formulation Development and Purchase departments.

- Handling regulatory queries, dossier requests, related to Pharma/supplement Products like Method validations, Specifications and Certificate of Analysis (CoA) for herbal drug substances, CoAs for finished products, nutritional value declarations, data required for CPSR, CTD dossiers etc.

- Supporting QA divisions in the evaluation of market complaint samples, OOS/OOT of commercial stability studies. Responsible to ensure R&D support to QA for facing regulatory audits like GMP, ISO, FDA etc. through necessary documents.

- To be responsible for division's activities covering method development, method validation, stability studies and method transfer activities related to Personal Care, Baby Care, Botanique Range and Home Care Products.

- To be able to guide and monitor the evaluation of benchmark products during development and qualification of alternate vendors in association with FD and Purchase.

- To be responsible for approval of Specifications for raw materials, excipients, finished products and related Standard Test Procedures (STPs), General Test Procedures (GTPs) in HGSM system.

- To take part in BIS committee for cosmetic products and ingredients and providing the strategic decision making of ingredients and also influencing the regulatory decision in the committee.

- Guiding the team members for publication of scientific research articles in the area of personal care research in collaboration with formulation development and other cross functional teams.