Dy.Manager/Manager - Technical Operations(Injectables)

Candidate should be B.Pharmacy/M.Pharmacy/Ph.d with 15 to 20 years of experience in

Technology transfer and process developement from a reputed Pharmaceutical organisation.

1. Expertise in Manufacturing science & technology of Parenteral, Ophthalmic and Solid Orals dosage forms belonging to Oncology, and the general category of products for USA markets.

2. Proficiency in Alliance Management & Project Management Methodologies

3. A good understanding of Packaging Development, Supply Chain Management, and plant technical operations would be an added advantage

4. Strong intrapreneurial skills and mindset from start-up to established organisation

5. Proficient in Microsoft Office Suite

1. Lead and oversee the Technology Transfer function, including planning, troubleshooting, and technical support in R&D and commercial launches

2. Drive process development & optimisation activities by working in a cross-functional environment.

3. Lead and oversee the Technology Transfer function of pharmaceutical products, including planning, formulating, and timely delivery.

4. Provide strategic input on processes, technologies, capacities, etc., to support existing and future products.

5. Anticipate, communicate, and solve technical challenges in manufacturing during commercial manufacturing.

6. To work as an interface between R&D, plant, and commercial teams to ensure the timely launch of products.

7. Provide inputs on regulatory strategies for early market entries like pre-validation, validation, protocol-based studies etc.

8. Provide technical support for the selection of types of equipment in terms of capacity, technical requirements, FAT, and qualification of equipment.

9. Collaborate closely with Regulatory Affairs staff to ensure all development activities are in accordance with the latest guidelines.

10. To work with CFTs on financial forecasts and budgets as & when required.

11. Lead technical inputs for investigations and regulatory inspections.

12. Work closely with regulatory and supply chain to plan for day-1 launch upon product approval.

13. Manage, coach, mentor, and motivate employees for outstanding performance.

14. Efficiently represent the formulation, technology transfer, and packaging development functions at all cross-department and leadership meetings.

15. Any other ad hoc tasks assigned by the management

1. Autonomy and leadership.

2. Ability to communicate effectively, negotiate, and persuade.

3. Ability to work on multiple projects at the same time.

4. Ability to keep tight deadlines and work under pressure.

5. Flexibility and ability to adapt to change.

6. Proficient in managing business relationship at senior level /functional heads and able to work & deliver within teams of different nationality / ethnic groups, across the geographies Fluency in English (written and spoken).

7. Organizational skills and structured work habits.