RESEARCH SCIENTIST

Job Description

Primary Responsibilities: Lead product development team for formulation development of ophthalmic/parenteral/injectable drug products
• Experience of managing product development team of around 3 people
• More than 7 years of industrial research experience around formulation development for NCE, branded generics (505b2) and generic drug products (complex injectables like liposome, nanoemulsions, polymer conjugates, nanoparticles, microspheres & depot sterile), injectable suspension, lyophilized products, aqueous and non-aqueous injection for regulatory market including experience with drug device combination products like cartridges, pre-filled syringes etc.
Manage, train and mentor team members
• Appreciable track record of managing team by with active participation in recruitment, training & talent upskilling activities for team
Responsible for enhancing productivity and team
• Capable to effectively transfer the knowledge to team, through strong reporting and verbal communication
Ensure that individual team member adheres and follows the system SOPs and provide training for same
• Ability to create vibrant work culture, aligned to GMP principles and in compliance to quality and safety
Responsible for the formulation, primary packaging, and manufacturing process development for ophthalmic/parenteral/injectable drug products for small molecules, proteins/peptides and biologics
• Technical expertise for lab scale formulation development strategies, based on Quality by Design (QbD), Design of Experiments (DoE), and risk assessment concepts
• Deep understanding of techniques to evaluate the QTPP, CQA s, CPP and CMA s
• Technical discretion in the design, execution, and interpretation of experiments
• Know how knowledge for formulation development techniques for complex injectables such as liposome, nanoemulsions, polymer conjugates, nanoparticles, microspheres, and complex formation
• Expertise in design and optimization of lyophilization cycle for small molecules and large molecules
• Handful skills for interpretation of results, drawing scientifically based conclusions, writing, and reviewing technical report
• Prior experience in de-formulation of branded product (Q1/Q2 composition) and comparability study
• Sound knowledge of in vitro in vivo correlation and PK-PD relationships
• Actively involved in drafting, review, and approval of specifications for drug products
• Deep understanding of filter selection, filter optimization and filter validation studies
• Prior experience of design of study and interpretation of analytical data for extractable and leachable studies
• Understanding of containment/isolator requirement for potent drug substance will be plus
• Basic knowledge about controlled substance handling will be advantageous.
• Preparation and review of drug device combination documents will be additional advantage
Responsible for Designs and develops formulations and manufacturing processes to support clinical trials, registration, and commercial product launch
• Knowledge of phase appropriate GMP quality system (early phase & late phase) and appreciable understanding of clinical study DP supply requirement
Responsible for writing & review of project proposals & report for client
• Well versed with the methodology for writing proposal, which shall include detailed scope of project, concise key deliverables, and breakup for project costing components
• Good analytical data interpretation skills and report writing skill with creative thinking ability
Support for client visit and audits
• Earlier exposure to regulatory and client audit will be added advantage
• Capable to handle multiple client audits with due diligence to system improvement
Responsible for cross-functional co-ordination
• Strong management skills with wide experience of working/coordinating both internal & external partners
• Good oral communication and interpersonal skills for successfully driving programs involving multiple stakeholders
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Keyskills :
chemistryquality by designhplcdesign of experimentsapivalidation