R&D Manager-API

Location :
New Delhi, India
Duration :
Full time
Website :

About Pharma Alley

Pharma 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. & Ph.D. in Organic Chemistry, Medicinal Chemistry, or related field.

· Experience  : 4-5 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.

To apply for the position, please fill out the application form using the link below. Make sure to provide accurate details, upload your updated resume, and include links to any past projects or portfolios.  Apply here :
form link>

For any queries, contact Recruitment Team   on [HIDDEN TEXT]