Position: Manager-Allogeneic Biology

Company Name: TotiCell Health & Research

Job Responsibilities

Management Functions:

 Leading product / manufacturing process design & development and ensuring compliance with
quality standard;
 Write various SOP of equipment and processes;
 Umbilical Cord Tissue receiving, Documentation, Process and Testing;
 Culture of Mesenchymal Stem cell;
 Testing of Mesenchymal Stem cell;
 Gained exposure in cell culture, Microbiology testing and engineering processes; involved in
producing current and new cell culture products;
 Skilled in handling, expansion & cryopreservation of Mesenchymal stem cell, PBSC, BMAC &
PBSC;
 An effective communicator with strong relationship management, negotiation, coordination and
analytical skills;

Cell Culture:

 Engaging in isolation and differentiation of WJD-Mesenchymal stem cells from umbilical cord
tissue Processing and Cryopreservation, Processing of Platelet Rich Plasma (PRP) stromal
vascular fraction (SVF), and PBSC;
 Performing differentiation & CFU assay, Potency Testing of cells;
 Testing for Mycoplasma, Bacterial Endotoxin & other infectious parameters;
 Performing Trypsinization using enzyme;
 Using various expansion techniques for multiplication of cells;
 Overseeing functions related to microscopy, preparing microbial cultures & samples and looking
after growth, isolation and identification of microorganisms and bacterial staining;
 Assessing and evaluating range of samples and tracking of micro-organisms in range of
environment;
 Ensuring the up keep of lab hygiene and adhering to cGMP during the course of manufacturing;

Quality Control/ Quality Assurance:

 Ensuring compliance to various quality measures for analytical trials in coordination with unit
QC labs;
 Conducting various tests & inspections to ensure that products developed are in compliance with
pre-set technical specifications;
 Managing the maintenance & calibration of equipment's related to techniques
 Doing validation of new product, write validation reports before release into the operations;
 Plot and analyses various quality graphs/charts, helps in quality improvement
 Participating in various EQAS Programme for quality improvement;
  Implementing quality tools to enhance quality of products and monitoring adherence to quality
systems along with maintenance of requisite documents;
 Supervision of all cleaning and housekeeping, checking contamination by Environmental
monitoring as per GMP Guidelines;
 Ensuring that all appropriate procedures and standards as per GLP regulations are followed for
the collection & preservation of analytical samples;
 Experience of active participation in various successful international audits like WHO GMP,
AABB, NABL, ISO & CAP etc.;
 Isolation, expansion, differentiation & cryopreservation of WJD- Mesenchymal stem cell derived
from human umbilical cord Tissue;

Major processes handled and validated:

 Cell culture Media preparation

 Mycoplasma Testing
 Endotoxin Testing
 CFU Testing
 Testing of Trilineage differentiation
 Environment Monitoring
 Processing & Cryopreservation of Mesenchymal stem cells from Umbilical Cord (WJD MSC)
 Microscopy and cell counting using with trypan blue
 Processing of Platelet Rich Plasma (PRP)
 Processing of stromal vascular fraction (SVF)
 Processing and Cryopreservation of Peripheral blood (PBSC) stem cell for future use;
 Any other task assigned by Authority

Employment Status

 Full-time

Educational Requirements

 Bachelor of Science (BSc) in Microbiology

Experience Requirements

 10 to 15 year(s)

Additional Requirements

 Age 30 to 45 years
 Both males and females are allowed to apply.
 Proven track record in basic research and/or drug development in, stem cell biology, genome
editing, or molecular cellular biology;
 Experience managing scientists with demonstration of both leadership and partnership;
 Ability to excel in cross-functional collaborations both internally and externally;
 Ability to quickly identify gaps, agile in adapting and learning on the job;
 Ability to think critically, synthesize and extract simple principles from complex datasets,
communicate effectively across broad spectrum of audience, with excellent written skills;
 Experience in scientific guidance on strategic and operating decisions, setting strategy, and
Performance goals;
 Fluent in English and Sound knowledge in MS Application programs.