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M.J. Biopharm Walk-In Drive | PDL (Upstream, Downstream, HPLC, Analytical) | Pune
Vacant Positions:
1. Process Development Lab (Upstream) – Junior Executive/ Executive/ Senior Executive/ Assistant Manager/Deputy Manager
2. Process Development Lab (Downstream) – Junior Executive/ Executive/ Senior Executive/ Assistant Manager/Deputy Manager
3. Process Development Lab (HPLC, Analytical) – Junior Executive/ Executive/ Senior Executive/ Assistant Manager/Deputy Manager
Preferred candidate profile:
Qualification: M.Sc./ B. Tech/ B.E./ M. Tech/ M. E. (Analytical Chemistry/ Biotechnology)
Experience: 3 years to 15 years
Job Description:
1. Process Development Lab (Upstream):
- Development and implementation of efficient Upstream and recovery processes, with a focus on biosimilars and novel biotherapeutics.
- Well verse with QBD guided upstream process development, scale down model and process characterization.
- To scale-up and technology transfer to higher scales.
- Should have strong understanding of software used for automation of fermentation and recovery (Centrifugation/ homogenization and NLT ) operations.
- Hands-on experience on fermenter, high pressure homogenizer, centrifugation system, decontamination systems, Class A and Biosafety equipment’s ( PDL and Pilot Plant ), upstream and recovery related all accessories, DHS, HPHV, etc.
- Prepare technical documentation, including reports, SOPs, and presentations, to facilitate the tech transfer of processes at higher scales.
- To investigate and timely complete deviation, CAPA and change control.
2. Process Development Lab (Downstream):
- Development and implementation of efficient Upstream and downstream purification processes, with a focus on biosimilars and novel biotherapeutics.
- Well verse with QBD guided downstream process development, scale down model and process characterization.
- To scale-up and technology transfer to higher scales.
- Independently conduct DOE based purification experiments, analyze experimental data, and optimize upstream and downstream processes for therapeutic proteins.
- Should be focused on assessing recent technologies for development of cost-effective newer technologies for capture and purification of biotherapeutics.
- Should have strong understanding of softwares used for automation of purification operations.
- Must be focused on usage of statistical tools to evaluate process performance and process consistency.
- To ensure that cGMP is implemented and followed strictly in all aspects of PDL.
- Hands-on experience of Akta Avant, Akta explorer, Centrifuge, Columns (Glass and stainless steel), Novasep chromatography, Lyophilizer, PCS, DHS, HPHV, etc.
- Prepare technical documentation, including reports, SOPs, and presentations, to facilitate the tech transfer of processes at higher scales.
- To investigate and timely complete deviation, CAPA and change control.
3. Process Development Lab (HPLC, Analytical):
- Analytical development & review of In-process samples analysis by DCW & LOD, SDS-PAGE and maintain data for comparison.
- Analytical development and analysis of release tests like Host Cell DNA, Host Cell Protein, and residual trypsin, residual carboxypeptidase.
- Analysis of Trypsin & Carboxypeptidase B raw materials (SDS PAGE, Specific activity)Preparation of Protocols, execution of studies and final report after the completion of studies.
- Installation, Qualification and Performance qualification Protocol and Report preparation as part of Instrument qualification.
- Maintenance & Reconciliation of Molecular biology chemicals, Buffers and kits.
- Pipettes, Instruments and Equipment maintenance (Calibration, Verification or Validation) etc. and maintain the log books at appropriate place.
- Qualification and Validation of analytical methods.
- Imparting Training and training records & Analyst Qualification of New Joiners/ Analysts in Lab.
- q-PCR method development and effective implementation for Host cell DNA analysis.
Click on the below link to apply: http://nauk.in/bzWU5FA
