Shailaja Gada Saxena
Navi Mumbai
Summary
Business professional with 25 years proven track record in driving organizational growth and enhancing operational efficiency in diagnostics. Known for strong focus on team collaboration and achieving results in dynamic environments. Recognized for strategic planning, financial oversight, and adaptability with deep understanding of diagnostic technologies, lab operations, R&D, with understanding of global and local regulatory framework.
Overview
26
26
years of professional experience
Work History
Business Head Diagnostic Services and Regenerative Medicine
Reliance Life Sciences, Dhirubhai Ambani Life Sciences Centre
04.2022 - Current
- Responsible for managing P&L for diagnostics, cord blood banking and stem cell research
- Digital transformation by implementation of enterprise-wide digitalization (LIMS, AI driven analytics), CRM platform, Saleforce management platform.
- Managed cross-functional teams of more than 200 employees across R&D, operations, medical affairs, customercare, logistics, procurement, sales, etc.
- Streamline lab operations, reducing COGS, increasing throughput via automation and better resource management.
- Management of entire diagnostic workflow in a high throughput CAP/ NABL certified molecular pathology laboratory
- Setting up various labs as a part of hub and spoke network lab project
- Key account management
Technical Head : Diagnostic Services and Head: Regenerative Medicine
Reliance Life Sciences, Dhirubhai Ambani Life Sciences Centre
08.2020 - 03.2022
- Managing lab operations and developing assays across Cytogenetics and Molecular Diagnostic Testing including areas of inherited genetic disease, oncology, pharmacogenomics, infectious diseases, cytogenetics, histocompatibility.
- Set up Covid-19 testing laboratory with a capacity of handling 30000 samples per day.
- Evaluation of new tests and technologies, development and validation of technically complex clinical molecular assays for diagnostic testing along with good analytical skills and troubleshooting abilities
- Selection of instruments, lab designing, test validations, designing of report format, staff selection
- NABL and CAP approved authorized signatory for Molecular Genetics, Molecular Microbiology, Cytogenetics, Flow Cytometry and Histocompatibility.
- Operational execution of network labs in Jamnagar, Gorakhpur and Surat
- Mentor/ co-guide for 5 PhD student.
- Execution of multiple research projects.
- Lead the team for NABL (National Accreditation Board for Testing & Calibrating Laboratories) accreditation for the Molecular Medicine laboratory since 2005, and CAP (College of American Pathologists) since 2007.
- Lead the team for AABB (American Association of Blood Bank) accreditation for Cord blood repository and cell therapy facility and FDA inspections since 2019.
Head - Molecular Medicine and Head: Regenerative Medicine
Reliance Life Sciences, Dhirubhai Ambani Life Sciences Centre
04.2018 - 08.2020
- Lead both Molecular Medicine and Regenerative Medicine division for highest level of performance as per regulatory guidelines.
- Lead Research and Development for both the divisions
- Expansion the Molecular Diagnostic Test Menu in the field of Oncology, Genetics, Pharmacogenetics, Predictive diagnosis and Microbial pathology – Over 200 tests developed and launched which are NABL/ CAP certified.
- Genetic counseling
- Development and Execution of Research and Clinical trial projects
- Coordination of lab operations with section heads
- Mentoring 4 Ph.D. students.
- Mentored around 30 trainee students
- Leading the stem cell research, live skin substitute project and adipose tissue derived mesenchymal stem cell project
- Conducting several marketing activities, sales training, CMEs/ RTMs
- Well versed with molecular techniques such as PCR, RQ- PCR, Sanger Sequencing, MLPA, Next Generation Sequencing (NGS), Karyotyping, FISH, Embryo Biopsy
- Also experienced in Intracytoplasmic Sperm Injection, Laser Assisted Hatching, Cryopreservation of Embryos, In Vitro Maturation of Oocytes
- Worked on Derivation of embryonic stem cell lines, Isolation of Inner Cell Mass for the blastocyst using a novel technique for derivation of Embryonic Stem Cells, Culturing and passaging of embryonic stem cells
Head - Molecular Medicine
Reliance Life Sciences, Dhirubhai Ambani Life Sciences Centre
04.2014 - 03.2018
- Lead both Molecular Medicine and Regenerative Medicine division for highest level of performance as per regulatory guidelines.
- Lead Research and Development for both the divisions
- Expansion the Molecular Diagnostic Test Menu in the field of Oncology, Genetics, Pharmacogenetics, Predictive diagnosis and Microbial pathology – Over 200 tests developed and launched which are NABL/ CAP certified.
- Genetic counseling
- Development and Execution of Research and Clinical trial projects
- Coordination of lab operations with section heads
- Mentoring 4 Ph.D. students.
- Mentored around 30 trainee students
- Leading the stem cell research, live skin substitute project and adipose tissue derived mesenchymal stem cell project
- Conducting several marketing activities, sales training, CMEs/ RTMs
- Well versed with molecular techniques such as PCR, RQ- PCR, Sanger Sequencing, MLPA, Next Generation Sequencing (NGS), Karyotyping, FISH, Embryo Biopsy
- Also experienced in Intracytoplasmic Sperm Injection, Laser Assisted Hatching, Cryopreservation of Embryos, In Vitro Maturation of Oocytes
- Worked on Derivation of embryonic stem cell lines, Isolation of Inner Cell Mass for the blastocyst using a novel technique for derivation of Embryonic Stem Cells, Culturing and passaging of embryonic stem cells
Team Lead: R&D, Molecular Medicine
Reliance Life Sciences, Dhirubhai Ambani Life Sciences Centre
04.2010 - 04.2014
- Development and Validation of various molecular and cytogenetic assays for genetic disorders, infectious diseases, drug resistance, oncology, pharmacogenetics etc.
- Including Real–Time based molecular analysis of BCR-ABL transcripts in Chronic leukemia patients, Allele specific PCR based molecular analysis for Jak2 v617 exon 14, High resolution HLA typing for HLA A, B, DR, DP, DQ by Next generation sequencing, Beta thalassemia sequencing, Testing for Alpha and delta thalassemia by ARMS PCR, Alk FISH testing, Testing for K-ras, N-ras, BRAF by sequencing, Testing for C-KIT and PDGFRA by sequencing, Testing for MDS panel including del(5q), del(7q), trisomy 8, del(20q) by FISH, Real time based TB PCR, T and B cell HLA cross match by flow cytometry, Qualitative real time PCR for HIV, HBV, HCV, ParvoVirus B19
- Troubleshooting of various molecular and cytogenetics procedures and instruments.
- Dissemination of domain knowledge through preparation of product literatures, marketing handouts and training activities.
- Standardization of preimplantation genetic diagnosis for hemoglobinopathies
Research Scientist/ Section supervisor (Cytogenetics), Molecular Medicine
Reliance Life Sciences, Dhirubhai Ambani Life Sciences Centre
12.2005 - 04.2010
- Lead the cytogenetics team
- Reporting of Cytogenetics results with zero error at best in class turnaround times
- Genetic counselling
Research Associate, Assisted Reproduction, Genetics & Embryonic Stem Cells
Reliance Life Sciences, H.N. Hospital and Research Center
07.2000 - 12.2005
- Set up of Molecular Diagnostics and cytogenetics Laboratory as per FDA and NABL standards
- Development and Introduction of diagnostic tests in the lab
- Set up the preimplantation genetic screening program
- Standardization of various cytogenetics and molecular genetics assays
- PCR based diagnosis of TB/ HIV/ HBV/ HCV/ CMV/ Viral loads/ HLA typing/ HBV-HCV Genotyping etc.
- Successfully standardized and launched various services including Ovarian Tissue Cryopreservation, In vitro maturation of oocytes, FISH on follicular fluid cells for detection of low grade gonadal mosaicism, Isolation of Inner Cell Mass for the blastocyst using Laser for derivation of Embryonic Stem Cells.
- Imparting technical as well as domain knowledge to the newer team members
Clinical Assistant, Assisted Reproduction
LIFE, Gada Nursing Home
10.1999 - 05.2000
- Involved with clinical protocol management for IVF patients
Research fellow, Assisted Reproduction and Genetic Laboratory
Assisted conception unit, University College Hosp
05.1999 - 09.1999
- Embryo biopsy and blastomere fixation for R&D
- Observer at the IVF laboratory and genetics laboratory at UCL
Education
Ph.D. -
Mumbai University
12-2013
M.Sc. - Prenatal Genetics and Fetal Medicine
University College London
01.1999
M.B.B.S. -
M.G.M Medical College, Devi Ahilya Vishvavidyalay
01.1997
Skills
Operations management -Clinical lab operations to ensure efficiency, accuracy, scalability with focus on R&D, test menu expansion
Regulatory and quality compliance - Ensuring lab processed in line with CAP, NABL, ISO, FDA, ICMR standards
Strategic planning and execution - defining and doing the mission, vision and growth trajectory for diagnostics business
Client relationship management - Build long term mutually beneficial relationships with internal and external customers
People and cultural leadership - developed and retained motivated ethics-driven team with a strong patient focus team for more than 2 decade
Other Achievements
- Publications in peer-reviewed National and International journals.
- Authored several book chapters.
- Invited faculty in more than 100 national and international conferences
- Part of organizing committees for various conferences and workshops
- Several poster presentations and awards
Training
Trainedy in Italy, USA and UK in the area of Oocyte and Ovarian Tissue Cryopreservation, Molecular Biology Techniques, Preimplantation Genetic Diagnosis, In vitro Fertilization especially Blastocyst culture and freezing and thawing of embryos, stem cell culture, Tissue Engineering and Organ Transplantation
Timeline
Business Head Diagnostic Services and Regenerative Medicine
Reliance Life Sciences, Dhirubhai Ambani Life Sciences Centre
04.2022 - Current
Technical Head : Diagnostic Services and Head: Regenerative Medicine
Reliance Life Sciences, Dhirubhai Ambani Life Sciences Centre
08.2020 - 03.2022
Head - Molecular Medicine and Head: Regenerative Medicine
Reliance Life Sciences, Dhirubhai Ambani Life Sciences Centre
04.2018 - 08.2020
Head - Molecular Medicine
Reliance Life Sciences, Dhirubhai Ambani Life Sciences Centre
04.2014 - 03.2018
Team Lead: R&D, Molecular Medicine
Reliance Life Sciences, Dhirubhai Ambani Life Sciences Centre
04.2010 - 04.2014
Research Scientist/ Section supervisor (Cytogenetics), Molecular Medicine
Reliance Life Sciences, Dhirubhai Ambani Life Sciences Centre
12.2005 - 04.2010
Research Associate, Assisted Reproduction, Genetics & Embryonic Stem Cells
Reliance Life Sciences, H.N. Hospital and Research Center
07.2000 - 12.2005
Clinical Assistant, Assisted Reproduction
LIFE, Gada Nursing Home
10.1999 - 05.2000
Research fellow, Assisted Reproduction and Genetic Laboratory
Assisted conception unit, University College Hosp
05.1999 - 09.1999
M.Sc. - Prenatal Genetics and Fetal Medicine
University College London
Ph.D. -
Mumbai University
M.B.B.S. -
M.G.M Medical College, Devi Ahilya Vishvavidyalay