Senior Manager – Process R&D (API Synthesis)

Biopatrika; Bengaluru; On-site; INR 4,200,000 - 6,200,000; Full time

Job summary

Biopatrika in Bengaluru seeks a Senior Manager – Process R&D (API Synthesis) to lead design, optimization, scale-up and technology transfer of API synthesis for global markets, ensuring regulatory compliance and strong IP positioning.

You will drive synthetic route scouting, apply QbD and DoE to maximize yield, throughput and atom economy, while championing green chemistry and coordinating with IP and regulatory teams for DMFs/CMC submissions. Location: Bommasandra, Bengaluru.

Qualifications

• 12+ years of API R&D experience.
• Postgraduate degree in Organic Chemistry.

Responsibilities

• Design non-infringing synthetic routes and evaluate for cost-effectiveness and patent non-infringement (ROS).
• Apply QbD principles and DoE to define CPPs and CQAs to maximize yield and throughput.
• Implement green chemistry practices to reduce solvent use and improve COGS.
• Identify and control impurities per ICH guidelines and support regulatory dossiers (PDRs, DMFs/CMC).
• Oversee lab-to-kilolab and pilot-plant scale-up and manage tech transfer to manufacturing.
• Lead and develop the API R&D team and collaborate with IP and regulatory teams.

Skills

Process Development

QbD

DoE

Green Chemistry

Cross-Functional Collaboration

Education

M.Pharm/M.Tech/M.Sc (Organic Chemistry)

Job description

We are Hiring!!! Position: Senior Manager – Process R&D (API Synthesis) for global markets leads the design, optimization, scale-up, and technology transfer of Active Pharmaceutical Ingredient (API) synthetic processes to ensure commercial viability, regulatory compliance (USFDA, EMA, PMDA, WHO), and robust intellectual property positioning (01 vacancy) Department: Process API R&D, Synthetic Route Scouting & Process Development, Impurity Profiling & Regulatory Compliance, Scale-Up, Process Safety & Technology Transfer Experience: 12 years or more Location: Bommasandra, Bengaluru, Karnataka, India Qualifications: M.Pharm/M.Tech/M.Sc (Organic Chemistry)

Core Job Responsibilities

1. Synthetic Route Scouting & Process Development

   • Non-Infringing Route Design: Conceptualize and evaluate novel, cost-effective, and patent-non-infringing synthetic routes (ROS) for generic and NCE/CDMO APIs, collaborating closely with the Intellectual Property (IP) team to secure Freedom-to-Operate (FTO).
   • Process Optimization & QbD: Apply Quality by Design (QbD) principles and Design of Experiments (DoE) to define Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs), maximizing yield, throughput, and atom economy.
   • Green Chemistry & Cost Reduction: Implement sustainable chemistry practices—reducing solvent footprints, replacing hazardous reagents, minimizing effluent load, and improving overall Cost of Goods Sold (COGS) for lifecycle management projects.

2. Impurity Profiling & Regulatory Compliance

   • Impurity Control Strategy: Identify, synthesize, and establish purge factors for process-related impurities, degradation products, chiral isomers, and mutagenic impurities (nitrosamines, genotoxic impurities) in compliance with ICH Q3A, Q11, and M7 guidelines.
   • Global Regulatory Dossier Support: Author, review, and approve Process Development Reports (PDRs), CMC sections for Drug Master Files (DMFs/CEP/ASMF), and technical justifications for regulatory deficiency queries from global agencies (USFDA, EDQM, PMDA, Health Canada).
   • Starting Material Justification: Define and justify Regulatory Starting Materials (RSMs) per ICH Q11 expectations to mitigate regulatory pushback during global filings.

3. Scale-Up, Process Safety & Technology Transfer

   • Kilolab & Pilot Plant Execution: Oversee lab-to-kilolab and pilot-plant scale-up batches, troubleshooting mass/heat transfer limitations, crystallization kinetics, and polymorphic form consistency.
   • Process Safety Assessment: Partner with Process Safety Engineering to evaluate thermal hazards (DSC, ARC, RC1 calorimetry) and chemical reactivity prior to plant scale-up.
   • Commercial Technology Transfer:

4. Team Leadership & Cross-Functional Collaboration

   • Laboratory & Team Management:
   • Cross-Functional Alignment: