Manager, R&D – Complex Product Development (CPD)
Location: Ahmedabad, Gujarat, India
Company: Baxter
Job Requisition ID: JR - 195701
Employment Type: Full-Time
Experience Required: 15–20 Years
Job Overview
Baxter is hiring a Manager, R&D – Complex Product Development (CPD) to lead analytical research and development functions at its Ahmedabad site. This senior leadership role will oversee GMP and non-GMP analytical operations, including analytical method development, validation, technology transfers, stability studies, regulatory submissions, and plant/CMO technical support.
The position will act as sub-department leader for the Complex Product Development group, driving operational excellence, regulatory compliance, and scientific innovation across biopharmaceutical and complex formulation projects such as proteins, peptides, and iron formulations.
This is a strategic opportunity for experienced pharmaceutical R&D professionals with strong regulatory exposure, analytical expertise, and proven leadership capabilities in GMP environments.
Key Responsibilities
Analytical Development & Validation Leadership
Plan and monitor analytical method development, validation, pre-validation, and technology transfer activities.
Manage routine and accelerated stability studies, PDR studies, and analytical support for regulatory submissions.
Lead complex product initiatives including proteins, peptides, iron formulations, and niche biopharmaceuticals.
Ensure in-depth technical understanding of projects and deliver documentation within committed timelines.
Regulatory & Compliance Management
Provide scientifically sound responses to regulatory queries within stipulated timelines.
Review and approve SOPs, analytical methods, protocols, and regulatory submission documentation.
Ensure compliance with pharmacopeial updates, cGLP, ALCOA++ data integrity principles, and global regulatory expectations.
Support International Regulatory submissions including ANDA documentation and responses.
Participate in audits and inspections, ensuring readiness and compliance.
Quality Systems & Investigation Support
Provide technical guidance to Plant/CMO during OOS, OOT, LIR, NCR, and CAPA investigations.
Ensure timely closure of quality records and implementation of corrective and preventive actions.
Oversee compliance with HAZID, E&C, data integrity, training, and cGLP standards.
Instrumentation & Laboratory Operations
Provide subject matter expertise in HPLC, UPLC, GC, UV, MS, and other advanced analytical instrumentation.
Review URS/RFPs for new instruments and ensure timely installation, qualification, and validation.
Ensure availability of standards, impurities, columns, and resources for uninterrupted laboratory operations.
Implement improved analytical techniques and develop new methodologies where required.
Project & Cross-Functional Collaboration
Collaborate with Project Management, Regulatory Affairs, Quality, Formulation Development, Manufacturing, and external testing laboratories.
Review weekly and monthly work plans to ensure seamless execution.
Coordinate with production planning for validation and analytical support activities.
Approve R&D specifications, methods of analysis (MoA) for APIs, finished products, excipients, and packaging materials.
Support API and excipient vendor approval and DMF review processes.
Leadership & Operational Excellence
Guide and mentor analytical team members for protocol creation, execution, and report preparation.
Allocate projects and manage workload to ensure timely delivery.
Plan departmental CAPEX and monitor budget utilization.
Ensure adherence to Baxter’s Code of Conduct and internal quality procedures.
Drive laboratory operational excellence and continuous improvement initiatives.
Educational Qualification
M.Pharm / M.S. (Pharm.) / Ph.D. in Pharmaceutical Sciences or related discipline.
Required Skills and Experience
15–20 years of experience in Pharmaceutical R&D, Analytical Development, and Validation within GMP-regulated environments.
Proven expertise in complex product development involving proteins and peptides, preferably with US FDA regulatory exposure.
Strong knowledge of analytical method lifecycle management, technology transfer, pharmacopeial compliance, and regulatory dossier preparation.
Experience in regulatory submissions, ANDA filings, and responding to international regulatory authorities.
Proficiency in business systems such as TCU, Electronic Notebooks, Trackwise, Coupa, and related software.
Strong leadership, communication, and cross-functional collaboration skills.
Core Competencies
Strategic scientific leadership
Regulatory and compliance expertise
Strong analytical and critical thinking ability
Project management and execution excellence
Effective stakeholder engagement across global teams
Why Join Baxter?
Baxter’s R&D teams are at the forefront of developing innovative healthcare solutions that save and sustain lives globally. Employees benefit from professional development opportunities, health and wellness programs, paid time off, volunteer leave, and a collaborative culture focused on scientific excellence and patient impact.
Equal Employment Opportunity
Baxter is an equal opportunity employer and considers all qualified applicants without regard to legally protected characteristics. Reasonable accommodations are available for individuals with disabilities during the recruitment process.
This Manager, R&D – CPD role offers a senior leadership opportunity for experienced pharmaceutical scientists seeking to drive complex product innovation, regulatory success, and analytical excellence within a global healthcare organization.
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