As a Research Scientist in our API (Active Pharmaceutical Ingredient) development unit, you will be at the forefront of creating efficient and scalable synthetic processes. Your work will directly impact our global client projects and strengthen the pharmaceutical supply chain.
Key Responsibilities:
- Route Design & Development:
- Design and develop novel, cost-effective, and non-infringing synthetic routes for APIs and key intermediates.
- Conduct thorough evaluations of scientific literature and patent landscapes to ensure synthetic feasibility and freedom to operate (FTO).
- Process Optimization & Scale-Up:
- Perform hands-on lab-scale synthesis and meticulously optimize reaction conditions to maximize yield, purity, and safety.
- Actively support process development and scale-up activities, transferring technology from the laboratory to kilo-lab and pilot plant levels.
- Analytical & Regulatory Support:
- Collaborate closely with Analytical R&D teams for comprehensive impurity profiling, identification, and characterization of intermediates and final compounds.
- Support the preparation of robust technical data packages required for regulatory filings like DMF (Drug Master File) and ANDA (Abbreviated New Drug Application).
- Technology Transfer:
- Author detailed process development reports and play a key role in the successful technology transfer of developed processes to manufacturing sites.
- Safety & Compliance:
- Adhere strictly to all EHS (Environment, Health, and Safety) and cGMP (current Good Manufacturing Practices) guidelines in the laboratory.
- Maintain impeccable documentation, including electronic laboratory notebooks, MSDS, and reaction logs.
Desired Qualifications & Experience
- Educational Background: M.Sc. in Organic Chemistry is required. A Ph.D. in Organic Chemistry will be a significant advantage.
- Technical Skills: Strong theoretical and practical knowledge of modern organic synthesis, purification techniques, and spectroscopic characterization (NMR, HPLC, MS, etc.).
- Industry Knowledge: Understanding of API process development, patent literature, and regulatory requirements in the pharma industry is highly desirable.
- Personal Attributes: Excellent problem-solving skills, a keen eye for detail, and the ability to work effectively in a cross-functional team environment.
About Piramal Group & Piramal Pharma Solutions
In its three decades of existence, Piramal Group has become a trusted name, driven by a twin strategy of organic and inorganic growth. The Group is steadfast in its pursuit of inclusive growth while adhering to the highest standards of ethical and values-driven practices.
Piramal Pharma Solutions (PPS) is the Contract Development and Manufacturing arm of Piramal Group. We offer end-to-end development and manufacturing solutions across the entire drug life cycle. With a globally integrated network of facilities in North America, Europe, and Asia, we provide comprehensive services, including:
- Drug Discovery Solutions
- Process & Pharmaceutical Development
- Clinical Trial Supplies
- Commercial Supply of APIs and Finished Dosage Forms
- Specialized services in Highly Potent APIs (HPAPIs), Antibody-Drug Conjugations (ADCs), Sterile Fill/Finish, and Peptide Chemistry.
Our track record as a trusted service provider makes us a partner of choice for innovators and generic companies worldwide.
Our Commitment to Equal Opportunity
Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based on race, ethnicity, religion, color, national origin, gender, sexual orientation, gender identity, age, veteran status, disability status, or any other applicable legally protected characteristics.
Our employment decisions are based on merit, qualifications, skills, performance, and achievements. We are committed to providing reasonable accommodation for qualified individuals with disabilities and for individuals with needs related to their religious observance or practice.