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