Role & responsibilities

- Lead and execute formulation development activities for oral liquid and sterile injectable oncology products, including solutions, suspensions, lyophilized products, and other complex dosage forms.
- Conduct pre-formulation studies, API characterization, excipient compatibility studies, solubility enhancement studies, and selection of suitable formulation components and packaging systems.
- Develop robust, stable, and scalable formulations with emphasis on product stability, compatibility, sterility assurance, and overall product performance.
- Support development of sterile injectable formulations involving aseptic processing, filtration studies, terminal sterilization (where applicable), lyophilization cycle development, and container closure compatibility studies.
- Plan and execute laboratory trials, optimization batches, scale-up batches, exhibit/registration batches, and support successful technology transfer to manufacturing sites.
- Prepare and review formulation development protocols, reports, batch manufacturing records (BMRs), technical documents, scientific justifications, and support CMC documentation for regulatory submissions.
- Troubleshoot formulation, process, stability, and manufacturing-related challenges and provide scientific solutions to ensure successful product development.
- Apply Quality by Design (QbD), Design of Experiments (DoE), and risk assessment approaches during formulation and process development.
- Coordinate effectively with Analytical R&D;, Regulatory Affairs, Quality Assurance, Quality Control, Production, Engineering, and Project Management teams to achieve project milestones and timelines.
- Ensure compliance with cGMP, Good Documentation Practices (GDP), data integrity requirements, and oncology safety and containment procedures.




- Support investigations, root cause analysis, CAPA implementation, and continuous improvement initiatives.
- Assist in project planning, resource utilization, and timely completion of development activities.
- Guide and mentor junior scientists/executives and contribute to building technical capabilities within the formulation development team.
- Stay updated with emerging technologies, regulatory guidelines, scientific literature, and market trends related to oncology and complex generic product development.

Educational Qualification

- M.Pharm (Pharmaceutics) or equivalent qualification from a recognized university.
- Higher qualification in Pharmaceutical Sciences will be an added advantage.

Technical Competencies

- Strong hands-on experience in development of oral liquid and sterile injectable dosage forms, preferably oncology and high-potent pharmaceutical products (HPAPIs).
- Good understanding of formulation approaches involving solubilizers, surfactants, stabilizers, preservatives, antioxidants, buffering agents, and other critical excipients.
- Knowledge of sterile product development, aseptic processing, sterilization techniques, lyophilization, container closure systems, compatibility studies, and related regulatory expectations.
- Practical experience in QbD, Design of Experiments (DoE), risk assessment tools, and pharmaceutical product development lifecycle.
- Experience in scale-up, process optimization,



technology transfer, and manufacturing support.
- Valuable understanding of ICH guidelines and regulatory requirements for generic product development in regulated markets such as USFDA, EMA, and ROW.
- Ability to interpret analytical data, stability results, impurity trends, degradation pathways, and provide scientific recommendations.
- Familiarity with handling procedures, containment practices, and occupational safety requirements for cytotoxic and highly potent compounds.

Behavioral Competencies

- Robust technical problem-solving and decision-making skills.
- Effective project coordination and cross-functional collaboration abilities.
- Good leadership, mentoring, and team management skills.
- Strong communication, documentation, and presentation skills.
- Quality and compliance-oriented approach with a high sense of ownership.

Preferred Candidate Profile

- 810 years of relevant experience in pharmaceutical Formulation R&D;, with significant exposure to oncology oral liquid formulations, sterile injectable products, and/or high-potent pharmaceutical products (HPAPIs).
- Hands-on experience in formulation development activities from concept stage through scale-up, exhibit batches, technology transfer, and commercialization support.
- Experience in development of products intended for regulated markets such as USFDA, EMA, and other global markets.
- Exposure to regulatory documentation, CMC support, and addressing formulation-related technical queries will be an added advantage.
- Experience in working with cross-functional teams and contributing to successful execution of multiple development projects.

Interested candidates can apply or share their resumes on [email protected]

📌 Assistant / Deputy Manager - (Oral Liquid Oncology / Injectables) (Navi Mumbai)
🏢 Umedica Labs
📍 Navi Mumbai