Multiple Positions open across the following functions:
1 Bio-Bulk Manufacturing (Drug Substance)
Mammalian and Microbial (Upstream Process) :
Media preparation, Filtration, Aseptic technique, Inoculum Handling, Handling of SU bioreactor/RM, Perfusion technology, upstream analytical instruments.
Handling of SS Fermenter, Continuous centrifuge
Mammalian and Microbial (Downstream Process) :
Buffer preparation, Filtration Technique, SU Technology, chromatography, Column packing, TFF technique.
2 Upstream Process Development (UPD)
Mammalian and Microbial (Upstream Process) :
Mammalian: Handling of AMBR250, Expertise in perfusion technology, Media preparation, media and feed optimization at SF, Expertise in DOE and process characterization
Microbial: Handling of 5L-50L Fermenter, expertise in process optimization, DOE and process characterization
3 Downstream Process Development (DSP/PPD)
Hands on experience in development of protein purification unit operations (like Chromatography, Depth filtration, UFDF, refolding, conjugation reactions, etc.) for mammalian/microbial expressed antibodies and/therapeutic proteins.
Candidate should have awareness about principles of Scale up and scale-down model qualification, process characterization (PC) based on DOE approach, statistical analysis of PC data, technology transfer activities, troubleshooting of process during manufacturing, continuous process, etc.
Drafting/Reviewing of documents such as the study protocols, reports, BMR, TTD documents, etc.
Involve in functional supportive activities like equipment maintenance, calibration, compliance, etc.
4 Advance Analytical Technique (AAT)
Knowledge of analytical method development, method qualification and method transfer - Understanding of analytical instruments: HPLC, UPLC, SoloVPE, Maurice, DSC, CD, Plate reader
Drafting /Reviewing of documents such as the specification, justification for the specification, MOA, SSR, SSP, MVP, and MQR.
5 Method Validation (Quality)
To perform method validation, stability sample analysis and review of analytical data.
Preparation and review of Documents (Specification, STPs, TDS, SOP, COA, MVP, MVR MTR etc.)
Coordination with vendor for external calibration and with QC personal for in-house calibration and verification of laboratory instruments and equipment
6 Drug Product Development (DPD)
Hands on experience in liquid and lyophilized formulation development of therapeutic proteins like MAbs and other bispecific proteins.
Able to design and execute support studies for DP mfg process like, filter, tubing, CCS compatibility studies, etc. and on DP like agitation, TOR, temp excursion studies, etc.
Candidate having knowledge about combination product development for pens and auto-injector with regulatory requirements for the same will be added advantage. Knowledge about scaling up and down of dp formulation mfg process is preferable.
Drafting/Reviewing of documents such as the study protocols, reports, BMR, TTD documents, etc.
Experience: 4 to 10 Years
Qualification: M.Sc/M.Tech/M.Pharm (Biotech, Bioprocess Technology, Life science)
Walk-In-Interview Date : 5th May 2024, Sunday
Time : 9.30 AM - 6 PM
Venue : Novotel Ahmedabad. Iscon Cross Roads, Sarkhej - Gandhinagar Hwy, next to Wide Angle Cinema, Ahmedabad, Gujarat 380015.
Enzene Biosciences Ltd is a technology driven Biotech Company based out of Pune, India. We strive to harness disruptive innovation to enhance global healthcare. Enzene is in business of Biosimlilars, Phytopharma, Peptide and Regenerative Business.