We are conducting Walk-In interview for Biologics / Biopharma / Biosimilars experienced personnel,
Departments:
PRODUCTION / MANUFACTURING (Microbial / Mammalian / Vaccine /Enzyme Products):
UPSTREAM PROCESS : Microbial /Yeast /Mammalian /Vaccine Products & sound knowledge on Bioreactors. SOP's preparation with exposure in QMS.
DOWNSTREAM PROCESS: Purification process of Microbial /Yeast/ Mammalian/ Vaccine products & sound knowledge on chromatography & Filtration. SOP's preparation with exposure in QMS.
Experience: 02-08 Years.
Positions: Executive /Sr.Executive/Assistant Manager.
PRODUCT & REGULATORY STRATEGIES (Biosimilars):
CMC-RA: CMC(Module 2&3) content development & regulatory writing for rDNA biosimilar submissions. Thorough understanding of regulatory guidance's as applicable for CMC requirements of ICH, EMA, USFDA & other regulatory agencies.
NON-CLINICAL & CLINICAL-RA: Non clinical & clinical (Module 2, 4 & 5)content development & regulatory writing for rDNA biosimilar submissions. Thorough understanding of regulatory guidance's as applicable for non C/C requirements of ICH, EMA, USFDA & other regulatory agencies.
Experience:06-10 Years.
Positions:Assistant Manager / Dy Manager/ Manager.
TECHNOLOGY TRANSFER: Technology transfer protocols with objectives and timelines to execute TT's at various stages of product development with internal and external stakeholders. Good understanding about the technical nuances & regulatory requirements for TT's.
Experience : 06-08 Years.
Position: Assistant Manager / Dy Manager.
ANALYTICAL DEVELOPMENT:
EARLY STAGE DEVELOPMENT: Method development & validation in HPLC/UPLC methods for MAb's & glycosylated hormones, product characterisation. Instruments: CZE, SDS-PAGE, PCR.
Experience:02-05 Years.
Position: Jr.RA/Research Associate.
MASS SPECTROMETRY LAB: Experience in handiling LC-MS, ESI-MS/MS MALDI-TOF of proteins and peptides preferble. Independently should be able to handle mass spectrometry lab.
Experience: 03-06 Years.
Position: Research Associate / Sr. Research Associate.
GLOBAL PROJECT DEVELOPMENT-ANALYTICAL: Various analytical methods such as SEC.RP peptide mapping, electrophoresis (SDS-PAGE, IEF), Capillary electrophoresis(CZE, CE-SDS, cIEF) glycan etc.
Experience: 08-10 Years
Position: Assistant Manager /Dy Manager.
PROJECT MANAGEMENT(Vaccines / Insulin / Biotherapeutics):
Manage all the five level of Project Management: Initiation, planning, execution, monitoring & control and closing.
Technology transfer, Scale-Up, Manufacturing & Outsoucing scenarios (CRO/CMO) of Biological products like Vaccines. Antibodies, Biotherapeutics etc.
Experience: 10-14 Years.
Position: Manager/ Sr.Manager /AGM.
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