Associate Scientist I, R&D - Formulation & Development (F&D)
Req #: JR - 177870
Location: Ahmedabad, Gujarat, India
Company Overview
Baxter’s Research and Development teams innovate and develop creative solutions to meet global patient needs. Our collaborative environment spans scientists and engineers dedicated to creating life-saving products. We support our employees with benefits including parental support, continuing education, health and well-being programs, paid time off, and volunteer days.
Success Profile
Key traits we look for in our R&D team members:
Courage
Action-Oriented
Collaborative
Innovative
Comfortable with Ambiguity
Results-Driven
Job Summary
The Associate Scientist I will work as a formulation scientist supporting new product development and existing product improvements. This role involves formulation and stability testing, supporting Baxter’s external partners, and ensuring timely project delivery.
Key Responsibilities
Product Development
Conduct formulation development trials following Quality by Design (QbD) principles.
Compile, evaluate, and analyze development and stability data.
Prepare technical documentation including Master Formula Records (MFR), Product Development Reports (PDR), Product Development Lifecycle Management (PDLM) documents, protocols, and reports.
Provide technical information for cross-functional team meetings (Analytical, Regulatory, PSM, Product Quality, Manufacturing, CMOs, Project Management).
Support execution of stability and process validation batches at Baxter sites and CMOs.
Assist with technology transfer of drug products to manufacturing and contract manufacturing sites.
Review engineering and stability batch documentation.
Collect and review stability batch data for trending and artwork review.
Assist in reviewing technology transfer documents from CROs ensuring QbD alignment and regulatory compliance.
Support remediation projects related to regulatory commitments, Out of Specification (OOS), change control, CAPA, and product criticality.
Handle troubleshooting and investigation of OOS or Out of Trend (OOT) results during batch runs.
Collaborate with plant teams for new product introduction.
Support internal and external regulatory audits related to manufacturing processes.
Assist in handling market complaints related to products.
Stay updated on regulatory submissions and guidelines including ICH, US-FDA, MHRA, EMEA.
Identify and procure necessary resources, infrastructure, and instruments for formulation development.
Assist in complaint and deviation investigations, root cause analysis, and corrective actions.
Prepare and manage change control documentation and ensure timely closure.
Maintain compliance for lab equipment, instruments, documentation, and warehouse.
Prepare and update Standard Operating Procedures (SOPs) for review and approval.
Document experiments in Electronic Lab Notebook (ELN).
Identify needs for new equipment or instruments for continuous lab improvement.
Follow global quality procedures and conduct Hazard Identification Risk Assessment (HIRA) in coordination with EHS.
Administrative & Collaborative
Work collaboratively within cross-functional teams.
Liaise with customers, suppliers, and staff for procurement and queries.
Review entries in logbooks.
In absence of executive, assist Sub-department Manager with responsibilities.
Authorities & Communication
Hold projects due to resource constraints as directed by Sub-department Manager.
Make decisions on non-compliance results under guidance.
Communicate with sourcing, cross-functional teams, and management regarding product development, failures, or non-compliance issues.
Report project issues and implement action plans under supervision.
Qualifications
Education
M.S. (Pharm.), M. Pharm, or Ph.D. in Pharmaceutics.
Experience
1 to 8 years in formulation and development of injectable drug products.
Experience in writing protocols, reports, and presentations.
Expertise in formulation instrumentation and development strategies.
Knowledge of ICH guidelines and cGxP practices preferred.
Experience working in global cross-functional teams and project management is a plus.
Skills
Strong problem-solving and data synthesis abilities.
Effective communication across technical and non-technical teams.
Comfortable managing risk, ambiguity, and critical timelines.
Personal responsibility and ownership of results.
Quality-oriented and adaptable.
Ability to delegate and work collaboratively.
Location
Navratna Corporate Park
Tower A, Ground Floor
Tower B, 21st and 22nd Floor
Ahmedabad, Gujarat – 380058, India
Equal Employment Opportunity
Baxter is an equal opportunity employer committed to diversity and inclusion. We evaluate candidates without regard to race, color, religion, gender, sexual orientation, gender identity, disability, veteran status, or any other legally protected characteristic.
Reasonable Accommodations
Baxter provides reasonable accommodations during the application and interview process. Requests can be submitted [here].
Recruitment Fraud Notice
Beware of fraudulent parties impersonating Baxter employees or recruiters. Learn how to protect yourself by reviewing our Recruitment Fraud Notice.
How to Apply
Click Apply Now to submit your application.
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