Scientist - Product Development (R&D)

Job Title: Scientist – Product Development (R&D) – API / Intermediate Manufacturing

Location: Lodhiwala, Bhagwanpur, Haridwar, Uttarakhand

Reporting To: Senior Manager / Head – R&D Process Development

Experience: 7-8 years of experience in process development / scale‐up of APIs or intermediates in the pharmaceutical or fine chemical industry

Role Summary:

The Scientist – Product Development will be responsible for developing, optimizing and scaling‐up manufacturing processes of API intermediates (and possibly APIs) from laboratory through pilot to commercial scale. The role involves cross‐functional collaboration (R&D, Manufacturing, Quality, Regulatory and Engineering) to ensure robust, efficient, compliant production.

Key Responsibilities:

* Perform feasibility studies, literature & patent reviews to identify viable synthetic routes and process flows for intermediates / APIs.

* Design, execute and analyze lab‐scale experiments to develop and optimize synthetic routes, unit operations (reaction, crystallization, filtration, drying, etc.).

* Use process intensification, continuous/batch technologies, and design of experiments (DoE) / Quality by Design (QbD) approaches to maximize yield, throughput, selectivity, safety and cost‐effectiveness.

* Develop and validate downstream operations (work‐up, purification, isolation, drying, solvent recovery) and support impurity profile, control strategy.

* Plan and execute pilot‐scale and commercial scale‐up batches (kilolab, demonstration, plant) including technology transfer to manufacturing.

* Participate in process validation / verification campaigns, change control, process safety assessments, scale‐-up risk assessment and troubleshooting of off‐specifications or yield losses.

* Prepare technical development reports, justification reports, scale‐up/scale‐down studies, process safety documents, DMF / CMC filing support and regulatory documents.

* Collaborate with cross‐functional teams (Engineering, Quality, Supply Chain, Manufacturing) to ensure plant readiness, equipment qualification, materials sourcing, process layout and execution.

* Maintain laboratory documentation, standard operating procedures (SOPs), electronic lab notebook (ELN) entries, change logs and comply with GMP/GLP as applicable.

* Continuously monitor technology trends, green chemistry alternatives, sustainable processes, cost‐effective raw materials and make recommendations for improvement.

* Mentor junior scientists/technicians, support training and ensure safe lab/plant operations and good scientific practice.

Required Qualifications & Experience:

* MSc / MPharma in Chemistry / Chemical Engineering / Pharmaceutical Sciences (PhD preferred in some cases).

* Typically 3-7 years of experience in process development / scale‐up of APIs or intermediates in the pharmaceutical or fine chemical industry (adjust depending on level). For example, in one company a mid‐level scientist required 3–8 years in API process R&D.

* Hands‐on experience in organic synthesis, unit operations (crystallization, filtration, drying, extraction, distillation), and core analytical techniques (HPLC, GC, spectroscopy) to interpret synthetic / impurity / quality data.

* Experience in process scale‐up and technology transfer from laboratory to pilot / plant scale, with understanding of process safety, risk assessment, materials of construction, equipment selection.

* Familiarity with design of experiments (DoE), QbD, continuous manufacturing or flow chemistry approaches is highly desirable (see one job description referencing "Knowledge on Flow & process development and scale up from laboratory to commercial scale").

* Good communication, collaboration and presentation skills; ability to work across functions in a matrix environment.

* Strong analytical and problem‐solving capability; attention to detail and data‐driven decision‐making.

* Knowledge of GMP / GLP environment, regulatory filings (DMF/CMC), changes control and technical documentation.

Desired Attributes:

* Proactive mindset with drive for innovation, continuous improvement and cost‐efficiency.

* Ability to prioritize multiple projects, work under shifting timelines and adapt to changing business needs.

* Capacity to mentor and guide junior colleagues; act as a technical contributor and independent project owner.

* Keen interest in sustainable chemistry, resource conservation, process intensification and green solvent technologies

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Performance Metrics / KPIs:

* Successful scale‐up of process with defined throughput, yield, purity and cost targets.

* Reduction in manufacturing cost per kg of intermediate / API.

* Number of robust processes transferred to manufacturing without major deviations or yield losses.

* Compliance of processes with safety, quality and regulatory norms.

* Timely submission of technical reports, DMF / CMC sections and technology transfer dossiers.

* Implementation of process improvements or innovations leading to measurable gains (yield, cycle time, solvent recovery, sustainability).

Working Conditions:

* Work primarily in laboratory and pilot‐plant environments.

* Some site visits to manufacturing facility, vendor locations and hazardous substances handling.

* Collaboration with multiple functions and global teams.

* Standard working hours; flexibility may be required to meet project deadlines or support plant campaigns.

Career Path:

* Scientist → Senior Scientist → Principal Scientist / Team Lead → Manager – Process Development → Head of R&D Process.

* Opportunities for cross‐functional movement into manufacturing, quality or regulatory roles.

Job Types: Full-time, Permanent

Pay: From ₹100,000.00 per year

Work Location: In person