Formulation Scientist

The role is to be lead the design and development of complex injectable emulsion, suspensions and solutions for parenteral and ophthalmic dosage forms, oversees pr-formulation studies, lead the scale-up & technology transfer, troubleshoot complex formulation and processing issues.

• People management, proper planning and delegation of work, and motivation of team members

• Mentor team members in product development, tech transfer and scientific documentation

• Need eye for detail, excellent capability to review work allotted to team members to ensure right first time approach towards product development and quality documentation

• Identify development needs of team members and ensure appropriate and timely feedback is provided to them

• Proven track record of successful product development from start to filing and approval of drug products with focus on injectables in regulated markets and ROW

• Expertise in process optimization, scale-up, provide technical support for manufacturing and troubleshooting of commercial products

• Enable regular project tracking by communication with related departments like project management, business development, analytical department, RA, IPR, QA, Store, Purchase, manufacturing site.

• Address post submission queries of different regulatory agencies

• Knowledge of QbD based product development

• Preparation and review of R&D documents (MFR, BMR, TTD, PDR) for regulatory submission. Preparation of SOP & implementation.

• Sound knowledge of use of PAT Tools in product development

• Evaluation of machinery vendors and FAT

• Evaluation of project feasibility in terms of technical, IPR, regulatory and costing considerations in coordination with cross functional departments

• Well versed with Microsoft Office tools, DOE software

Profile:

• Strong interpersonal skills – able to work effectively with operational staff in the manufacturing site and project management.

• Knowledge of technology transfer and GMP pharmaceutical processes and scale-up and guidelines/regulations.

• Fluent in English and local language with good communication skills.

• Candidate should have exposure of Formulation development of injectable, Knowledge of regulatory market required.

Location:

Ambernath, Boisar