Umedica Laboratories Private Limited
Website:
umedicalabs.com
Job details:
Department: Research & Development (R&D) – Formulation Development
Dosage Form: Oral Liquid & Sterile Injectable (Oncology)
Industry: Pharmaceuticals – Oncology / Generic Drug Development
Experience: 12–14 Years
Number of Positions: 01
Reporting To: Head – Formulation R&D
Job Summary:
Umedica Laboratories is seeking an experienced, technically competent, and result-oriented Sr. Manager – Formulation Development to lead the development of oncology formulations, including oral liquid and sterile injectable dosage forms, for global regulated markets. The incumbent will be responsible for end-to-end product development activities encompassing pre-formulation, formulation optimization, process development, scale-up, technology transfer, regulatory support, and cross-functional team leadership while ensuring compliance with cGMP, data integrity, EHS, and containment requirements associated with handling high-potent oncology products (HPAPIs).
Key Responsibilities:
- Lead formulation development activities for oral liquid and sterile injectable oncology products, including solutions, suspensions, emulsions (where applicable), lyophilized products, and other complex dosage forms.
- Develop product development strategies based on Quality by Design (QbD) principles, Target Product Profile (TPP), critical quality attributes (CQAs), and regulatory expectations for global markets.
- Design robust, stable, and scalable formulations with focus on stability enhancement, bioavailability improvement, compatibility, sterility assurance, and overall product performance.
- Lead development of sterile formulations, including selection of manufacturing processes such as aseptic processing, terminal sterilization (where applicable), filtration studies, lyophilization cycle development, and container closure system evaluation.
- Plan, execute, and monitor laboratory batches, optimization studies, scale-up batches, exhibit/registration batches, and support successful technology transfer to manufacturing facilities.
- Provide technical expertise in troubleshooting formulation challenges, process-related issues, sterility concerns, stability failures, and commercial manufacturing challenges.
- Review and approve formulation development reports, protocols, batch manufacturing records, scientific rationales, technical risk assessments, and development documentation.
- Lead preparation, review, and technical justification of CMC sections for regulatory submissions in regulated and semi-regulated markets, including USFDA, EMA, MHRA, and ROW markets.
- Collaborate effectively with Analytical Development, Quality Assurance, Quality Control, Regulatory Affairs, Production, Engineering, Procurement, and Project Management teams to achieve project timelines.
- Ensure compliance with cGMP, Good Documentation Practices (GDP), data integrity requirements, and strict oncology safety and containment procedures.
- Conduct risk assessments, support investigations, root cause analysis, implement CAPA, and drive continuous improvement initiatives.
- Monitor project timelines, resource planning, and deliverables to ensure successful product development and commercialization.
- Guide, mentor, and develop a team of formulation scientists and executives, fostering a culture of scientific excellence, innovation, and compliance.
- Stay updated with emerging formulation technologies, regulatory guidelines, scientific literature, and the competitive landscape in oncology and complex generic product development.
Educational Qualification:
M.Pharm/MS / Ph.D. (Pharmaceutics) or equivalent qualification from a recognized university.
Technical Competencies:
- Strong expertise in development of oral liquid and sterile injectable dosage forms, particularly oncology and high-potent pharmaceutical products (HPAPIs).
- Comprehensive knowledge of formulation approaches involving solubilizers, surfactants, stabilizers, preservatives, antioxidants, buffering systems, and other critical excipients.
- In-depth understanding of sterile product development, aseptic processing, sterilization methods, lyophilization, container closure integrity, extractables & leachables, and compatibility studies.
- Hands-on experience with QbD, Design of Experiments (DoE), risk assessment tools (FMEA/Ishikawa), and pharmaceutical development lifecycle management.
- Experience in scale-up, process optimization, technology transfer, process validation support, and commercial manufacturing troubleshooting.
- Strong understanding of ICH guidelines, USFDA, EMA, and other international regulatory expectations for oncology and sterile product development.
- Ability to interpret analytical data, stability studies, dissolution/release profiles, impurity trends, degradation pathways, and product characterization data.
- Familiarity with handling requirements, containment practices, and occupational safety considerations for cytotoxic and highly potent compounds.
Preferred Candidate Profile:
- 12–15 years of relevant experience in pharmaceutical Formulation R&D, with significant hands-on experience in oncology oral liquids, sterile injectables, and/or high-potent pharmaceutical products (HPAPIs).
- Proven experience in leading formulation projects from concept to commercialization.
- Exposure to regulated market submissions (USFDA, EMA, and other global markets) will be preferred.
- Experience in managing R&D teams and driving cross-functional collaboration.
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