R&D Manager-API
Job Type:
Full-Time
Location:
New Delhi, India
About Pharm Alley
Pharm Alley is a technology-driven manufacturing and commercialization platform focused on API intermediates and pharmaceutical process solutions. The company supports pharmaceutical manufacturers and CDMOs by developing, sourcing, and scaling high-quality intermediates through robust process engineering, compliant manufacturing practices, and reliable supply-chain integration. Its operations emphasize process optimization, cost efficiency, regulatory alignment, and scalability, enabling partners to transition from laboratory-scale chemistry to consistent industrial production while meeting global quality and compliance standards.
Role Overview
The R&D Manager – API will be responsible for leading API process development projects from laboratory scale through pilot and plant scale-up. The role involves managing a small team of scientists, driving innovation in synthetic routes, ensuring regulatory compliance, and working closely with cross-functional teams to enable successful technology transfer and commercialization. This is a chemistry-first, execution-oriented role for someone comfortable operating in a fast-paced R&D and manufacturing environment.
Key Responsibilities:
Team Leadership: Mentor, motivate, and guide a team of scientists in synthetic/process chemistry and analytical development.
Project Management: Oversee R&D projects (New Product Development, Existing Product Development) from lab scale to commercialization and managing timelines.
Process Innovation: Develop, optimize, and scale-up robust, cost-effective, and non-infringing synthetic routes for APIs/Intermediates.
Analytical Support: Drive analytical method development, validation, impurity profiling, stability studies, and in-process controls for API batches.
Regulatory Compliance: Ensure all activities adhere to cGMP, GLP, and ICH guidelines; prepare technical documents for regulatory filings (e.g., Quality Overall Summary).
Cross-Functional Collaboration: Work closely with Production, Quality Assurance (QA), Regulatory Affairs, and External Partners (CROs/CMOs).
Technology & IP: Evaluate patents, develop non-infringement strategies, and introduce new technologies.
Key Deliverables:
Completion of Process development in Lab as per stipulated Timeline.
Successful scale-up & tech transfer at Plant.
Process Robustness and validation
Comprehensive technical reports & regulatory documents.
Qualifications & Skills:
Education: M.Sc. or Ph.D. in Organic Chemistry, Medicinal Chemistry, or related field.
Experience: 2-3 Year Experience in API process R&D, project management, and scale-up at Plant.
Technical Expertise: Strong organic synthesis, process chemistry, analytical techniques (HPLC, GC, LC-MS), and ICH guidelines knowledge.
Communication: Excellent written and verbal communication for technical and stakeholder presentations.
Benefits:
Be part of a mission-driven, high-impact project at the frontier of health-tech and biofabrication
Access to in-house rapid prototyping facilities and fabrication tools
Work closely with experts from across disciplines and geographies
Ownership of hardware subsystems with freedom to experiment and innovate
A startup environment with fast decision-making, steep learning curve, and real-world results
Competitive salary and opportunity to grow into a leadership role as we scale
Additional Information:
Applicants who do not fully meet all listed qualifications but demonstrate strong potential are also encouraged to apply.
Applications will be reviewed on a rolling basis until the position is filled.
We would like to emphasize that the pre-selection process is conducted by the responsible recruiters, not by artificial intelligence.
Shortlisted candidates will be contacted for the next steps.