Downstream Process Development ( MAbs ): Biologics

Responsibility brief:

Execution of downstream process activities as per design at downstream process development department with necessary documentation and with required and defined level of compliance.

Responsibilities:

1. Execution of downstream process development activities as per the design and documentation of all the downstream processing activities. Also, ensure proper and safe archival of downstream process related documents.
2. Ensure the correctness of the entries in the logbooks, lab notebook, batch records, solution preparation records and submission for review. Ensure compliance to Developmental Quality Assurance systems and Quality Assurance systems.
3. Preparation of reports and document preparation such as BMR, SPR, and SOP.
4. Co-ordination with QC for sample analysis which includes sample submission and receiving the results and co-ordination with QA for the issuance of batch records and other DQA documents. Also, co-ordination with other teams such as Upstream, Analytical, Engineering and SCM for cross functional activities.
5. Analytical data (process related) compilation, interpretation and systematic archival.
6. Data review and management.
7. Ensure smooth functioning of all the equipment in the downstream processing area which includes an oversight on the documentation of equipment related activities and tracking the calibration/preventive maintenance schedule.
8. Training and development of self on the operation of equipment, downstream processing concepts, new technologies in the field of purification etc., and attend all the relevant trainings.
9. Ensure safety of self and personnel in the Downstream PD lab.

Additional responsibilities:

1. Co-ordination with Manufacturing for cross functional activities.
2. Support downstream manufacturing activities based on requirement.