Job Description
Vacancy Description:
1. Process Development Lab (Upstream)
Designations: Junior Executive/ Executive/ Senior Executive/ Assistant Manager/Deputy Manager
Responsibilities:
- Creation and execution of effective recovery and upstream procedures, with an emphasis on innovative biotherapeutics and biosimilars.
- Knowledgeable about process characterisation, scale-down models, and upstream process development as directed by QBD.
- To transfer technology to larger scales and scale it up.
- Possess a solid understanding of the software required to automate processes related to fermentation and recovery (such as centrifugation, homogenization, and NLT).
- Practical knowledge of centrifugation systems, decontamination systems, high pressure homogenizers, fermenters, Class A and Biosafety equipment (PDL and Pilot Plant), upstream and recovery-related accessories, DHS, HPHV, etc.
- Create technical documentation to aid in the tech transfer of processes at bigger scales, such as presentations, SOPs, and reports.
- To look into deviations and promptly finish CAPA and change control.
2. Process Development Lab (Downstream)
Designations: Junior Executive/ Executive/ Senior Executive/ Assistant Manager/Deputy Manager
Responsibilities:
- Creation and use of effective purification techniques, both upstream and downstream, with an emphasis on innovative biotherapeutics and biosimilars.
- Well-versed in process characterisation, scale-down models, and downstream process development guided by QBD.
- To transfer technology to larger scales and scale it up.
- Conduct purification experiments based on DOE independently, evaluate experimental results, and optimize both upstream and downstream processes to produce therapeutic proteins.
- Possess a solid grasp of the software used to automate purifying processes.
- The use of statistical methods to assess process consistency and performance must be the main focus.
- To guarantee that cGMP is used and rigorously adhered to in every PDL component.
- Practical knowledge of Novasep chromatography, Akta Avant, Akta Explorer, Centrifuge, Glass and Stainless Steel Columns, Lyophilizer, PCS, DHS, HPHV, etc.
- Create technical documentation to aid in the tech transfer of processes at bigger scales, such as presentations, SOPs, and reports.
- to look into deviations and promptly finish CAPA and change control.
3. Process Development Lab (HPLC, Analytical)
Designations: Junior Executive/ Executive/ Senior Executive/ Assistant Manager/Deputy Manager
Responsibilities:
- Analytical creation and evaluation of DCW & LOD, SDS-PAGE, and in-process sample analysis, as well as data maintenance for comparison.
- Analytical design and evaluation of release tests, such as residual trypsin, residual carboxypeptidase, and host cell protein and DNA.
- Examination of the raw materials for trypsin and carboxypeptidase B (SDS PAGE, Specific activity)the creation of protocols, the conduct of the studies, and the final report following their conclusion.
- Installation, Certification, and Performance Certification As part of the instrument qualification process, prepare the protocol and reports.
- Reconciliation and upkeep of molecular biology kits, buffers, and chemicals.
- Pipettes, instruments, and equipment upkeep (validation, verification, or calibration), etc., as well as keeping the logbooks in their proper locations.
- Analytical method validation and qualification.
- Providing new hires and analysts in the lab with training, training records, and analyst qualification.
Important Note:
Walk-In at Pune (Only for the shortlisted candidates)
Click on the link to apply: http://nauk.in/bzWU5FA
We'll scrutinize your applications & select the suitable CVs.
Selected candidates will be informed for the Walk-In details (Venue, Date, Time, etc.) via email/ call/ message.
For all the above positions, candidates having good communication and interpersonal skills and sound exposure of working in a Regulatory Plant, cGMP/ GDP knowledge will be preferred.
All positions are for Pune location. Some positions may require working in shifts.