UMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations i.e., Injectables, Tablets, Capsules, Suspensions, Dry Syrups, etc. UMEDICA's manufacturing facility, located in Vapi (Gujarat), is approved by global regulatory. UMEDICA was founded in 1983 and has business operations in more than 85 countries including the USA, Canada, EU, UK, Australia, Middle East, Central & South American countries, Africa, Asia & CIS countries.
We at UMEDICA strive to achieve more through a culture of innovation & continuous improvement.
We are seeking an experienced and highly motivated Senior Manager – Formulation Development with strong expertise in Oral Solid Oncology Product Development. The incumbent will be responsible for leading formulation development activities from pre-formulation to exhibit/registration batches, ensuring timely execution of development projects in compliance with regulatory requirements for global markets.
The ideal candidate should possess extensive knowledge of oncology product handling, formulation design, process optimization, technology transfer, and regulatory documentation for oral solid dosage forms.
The remuneration package will be commensurate with the incumbent's professional experience and will be in line with market standards.
Job Title: Senior Manager – Formulation Development (Oral Solid Oncology)
Organization: Umedica Laboratories (Amoli Group)
Location: Turbhe, Navi Mumbai, Maharashtra
Department: Research & Development (R&D) – Formulation Development
Dosage Form: Oral Solid Dosage Form
Experience: 12–14 Years
Industry: Pharmaceuticals – Oncology / Generic Drug Development
Reporting To: Head – Formulation R&D
Key Responsibilities
- Lead formulation development of Oral Solid Oncology products (tablets, capsules, modified-release formulations) from concept to commercialization.
- Design and optimize formulations using QbD principles, pre-formulation studies, and excipient compatibility assessments.
- Drive development of cytotoxic/high-potency oncology products, ensuring compliance with safety and containment requirements.
- Oversee scale-up activities, including pilot, exhibit, validation, and commercial batches, and facilitate seamless technology transfer to manufacturing.
- Prepare and review development reports, regulatory documentation, and dossier support for US market
- Collaborate cross-functionally with Analytical R&D, Regulatory Affairs, Production, QA, Procurement, and Packaging teams to achieve project milestones.
- Manage multiple projects, ensuring timely delivery, effective risk mitigation, and resolution of formulation/process challenges.
- Lead, mentor, and develop a high-performing formulation team, fostering innovation and technical excellence.
- Ensure compliance with cGMP, GLP, data integrity, and quality standards, and support regulatory audits and inspections.
Required Qualifications
- M.Pharm / Ph.D. (Pharmaceutics preferred).
Required Experience
- 12–14 years of experience in Pharmaceutical Formulation R&D.
- Minimum 6–8 years of experience in Oncology Formulation Development.
- Hands-on experience in Oral Solid Dosage (OSD) Oncology Products.
- Experience in development for regulated markets such as USFDA, EMA, MHRA, Health Canada, and other global markets.
Technical Skills
- Oral Solid Dosage Form Development
- Oncology Formulation Development
- QbD (Quality by Design)
- Risk Assessment Tools
- Process Optimization and Scale-Up
- Technology Transfer
- Stability Studies
- Regulatory Documentation (CTD/eCTD)
- DOE (Design of Experiments)
- cGMP & GLP Compliance
- Product Lifecycle Management
Key Competencies
- Strong technical and scientific acumen
- Leadership and team management
- Project planning and execution
- Problem-solving and analytical thinking
- Cross-functional collaboration
- Communication and stakeholder management
- Decision-making and result orientation
Preferred Candidate Profile
- Proven track record in successful development and commercialization of oral solid oncology products.
- Strong understanding of regulatory expectations for oncology products in global markets.
- Experience working in a high-potency manufacturing and development environment.
- Ability to lead strategic R&D initiatives and drive innovation.
