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, 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).

The remuneration package will be commensurate with the incumbent’s professional experience and will be in line with market standards.

Job Title: Sr. Manager – Formulation Development (Oral Liquid & Injectable Oncology)

Organization: Umedica Laboratories (Amoli Group)

Location: Turbhe, Navi Mumbai, Maharashtra

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;

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

- Solid 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 .

📌 Sr. Manager – Formulation Development (Oral Liquid & Injectable Oncology) (Navi Mumbai)
🏢 Umedica Laboratories Private
📍 Navi Mumbai