We Are Hiring Asst. Manager for F&D; Department @ Concord Biotech, Valthera, Ahmedabad Plant.

Job Details:

Department: Formulation & Development (F&D;) Injectable

Designation: Senior Executive & Assistant Manager

Experience: 08 to 15 Years

Job Location: Valthera, Ahmedabad

Role Summary:

The Assistant Manager/Sr. Executive in Formulation & Development will spearhead the development of liquid and lyophilized injectable formulations for the US, ROW, and domestic markets. This role involves designing strategic plans, developing prototypes, conducting stability studies, and executing pilot bioequivalence studies. The incumbent will manage pre-exhibit and exhibit batch planning and execution, prepare Product Development Reports, and provide documentation support for regulatory filings, including Form-29 and import licenses. They will oversee the scale-up and optimization of manufacturing processes, ensuring seamless technology transfer from F&D; to production within set timelines. The role requires active collaboration with API manufacturers, CROs, and CMOs, and involves working with cross-functional teams to manage change controls related to manufacturing and packaging records. The Assistant Manager/Sr. Executive will also be responsible for creating and reviewing SOPs, ensuring compliance with GMP requirements, and coordinating with regulatory affairs to address deficiencies. Additionally, they will review batch records, process characterization reports, and validation reports, while also training and inspiring subordinates.

Role Responsibility:





- Develop formulations for liquid and lyophilized injections targeting the US, ROW, and domestic markets.

- Design strategic plans and develop prototypes, conducting stability studies and pilot bioequivalence studies.

- Plan and execute pre exhibit and exhibit batches, preparing Product Development Reports and supporting documentation for regulatory filings.

- Provide documentation support for license applications, including Form-29 and import licenses.

- Oversee the scale-up and optimization of manufacturing processes, ensuring timely technology transfer from F&D; to production.

- Collaborate with API manufacturers, CROs, and CMOs, and work with cross-functional teams to manage change controls related to manufacturing and packaging records.

- Create and review SOPs, ensuring compliance with GMP requirements, and coordinate with regulatory affairs to address deficiencies.

- Review batch records, process characterization reports, validation reports, and investigation reports.

- Train and motivate subordinates, fostering a collaborative and efficient work environment.

Interested candidates can apply for a Virtual Interview at the URL mentioned below:

https://welhire.ai/careers/concordbiotech/1993

Also share your CV on below mention mail Id:

[email protected]

Job Location:

Concord Biotech Limited

297-298/2P, At.: Valthera, Bavla Siyavada road.

Ta. Dholka. Dist: Ahmedabad, Gujarat, India 382225.

Location: https://maps.app.goo.gl/vNyDyJZvzjYGRJXA8

📌 We Are Hiring Asst.Manager For F&D Department @ Concord Biotech (Valthera)
🏢 Concord
📍 Valthera