Research Scientist/ Asst. Manager
- Evolet Healthcare
- 6 - 8 years
- Noida, Gurugram
- 21 hours ago
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Job Description
Job Opportunity: Research Scientist/ Asst. Manager Formulation Development (Injectable)
Job Summary:
The Research Scientist Formulation (Injectable) will lead the development, optimization, and lifecycle management of sterile injectable dosage forms including solutions, suspensions, emulsions, and lyophilized products. The role involves technical leadership, mentoring junior team members, ensuring regulatory compliance, and supporting scale-up, technology transfer, and regulatory submissions.
Key Responsibilities:
Formulation Development & Technical Leadership
Lead formulation development of injectable products (liquids and lyophilized) from feasibility to commercialization.
Design formulation strategies considering QTPP, CQAs, and risk assessment (QbD approach).
Perform and interpret pre-formulation, compatibility, and excipient screening studies.
Troubleshoot formulation, processing, and stability issues for injectable products.
Provide technical guidance and mentorship to Research Associates and junior scientists.
Sterile Processing & Scale-Up
Oversee aseptic processing activities including solution preparation, sterile filtration, vial/ampoule filling, and lyophilization.
Support scale-up, pilot batches, exhibit batches, and technology transfer to manufacturing sites.
Collaborate with engineering and production teams for process optimization.
Evaluation & Stability
Ensure evaluation of injectable including pH, osmolality, clarity, particulate matter,
assay, sterility, endotoxin, and reconstitution parameters.
Review and interpret stability data as per ICH guidelines and propose shelf-life.
Documentation & Regulatory Support
Author and review development reports, protocols, BMRs, SOPs, and technology transfer documents.
Support preparation and review of CMC sections for regulatory submissions (USFDA, EMA, WHO, DCGI).
Participate in regulatory audits and inspections; respond to queries and observations.
Compliance & EHS
Ensure adherence to cGMP, GLP, data integrity, aseptic practices, and EHS guidelines.
Drive continuous improvement in laboratory practices and compliance culture.
Educational Qualification
M. Pharm / Ph.D. in Pharmaceutics from a recognized university
7+years of experience in Formulation Development (Injectable)
What We Offer:
Friendly and supportive work environment
PF benefit
Medical Health Insurance
Rewards and Recognition and appreciation
Competitive salary and benefits
Growth and learning opportunities
Ready to join us?
Send your resume to: va****y@ev***t.in
Contact us at: 9971003***
Visit us: https://evolet.in/
Make your next career move count. Step into a role that values professionalism, positivity, and people skills. Were excited to meet you!
Job Classification
Industry: Pharmaceutical & Life SciencesFunctional Area / Department: Research & DevelopmentRole Category: Research & Development - OtherRole: Research & Development - OtherEmployement Type: Full timeContact Details:
Company: Evolet HealthcareLocation(s): Noida, Gurugram
Keyskills: Injectables Lyophilization Liquid Isolators Sterilization Pre-filled syringe ampoule Parenteral Drug Machine Handling Clean room Validation
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