Brij Singla has over 20 years of experience in the Biotechnology industries.

Brij has spent many years in different roles and responsibilities with Biotechnology companies in disciplines from Facilities & Project Engineering, Operations, Technical Services, Technology Transfer, Validation, and Management. His career in Biotechnology industry started by leading Clean Room Qualification, ISO Classification and Dynamic Environment Monitoring of large scale facility with 22 units for a global biotechnology company, moving into a role where he supported validation and compliance initiatives both internally and with partner companies throughout the US.

Brij is skilled in Biotechnology Process design & development, manufacturing and support services, especially, Microbial Fermentation and Mammalian & Insect Cell Culture processes. He has a valuable experience in building quality into design and development of processes with a special focus on "doing the right thing." Brij has facilitated the implementation of many programs including quality programs, validation systems, master plans, process control strategies, process comparability protocols, SAS SPC tools, FMEA and remediation projects.

Merck Green Belt Certified, Brij Singla's talent lies in his ability to distil out workable solutions, using Lean Six Sigma Methodology. He listens to client concerns and understands their needs, before providing options to meet their expectations. He is a thought provoking leader who is well versed in handling complex projects within specified time &budget. Brij recently expanded his experience in technology transfer & process validation by pioneering manufacturing of 1st cGMP/validation batch by utilizing Single Use Disposable Bioreactor, including Harvest & Recovery, instead of using traditional stainless steel bioreactors for mammalian/Insect cell culture processes.

Brij is known as a Tech Transfer and Process Validation Strategist, whose fundamental goal is to design the success of a PV campaign into Process Development and Characterization studies. He has recently spearheaded completion of one (1) Insect Cell process and another Microbial Fermentation process validation from the tech transfer till the start of CPV, and now building foundation to ensure success of three (3) PV campaigns for Microbial and Mammalian cell culture processes.

Brij has analysed new investments and complex strategic partnership options with consortiums, using financial modelling and statistical tools by formulating cost, benefits, efforts vs. risks matrices, including estimation of human and capital resource utilization to operate a Biological Manufacturing facility.

Brij has profound knowledge of US FDA and EMEA regulatory guidelines and has defended several Technical, QA/Validation and Operations Systems during PAI and cGMP audits.

Mr. Singla holds B.E.ChE from Panjab University, India and M.S.ChE from Oregon State University, USA with specialization in Microbial Fermentation & Purification Processes. He has recently completed his M.B.A from Kenan Flagler Business School, UNC Chapel Hill, USA to supplement his technical skills with specialization in Finance, and therefore, expanded his services to portfolio analysis & management; due-diligence, Evaluation of tangible/intangible assets, business process mapping, risk assessments and post-acquisition integration support related to Mergers/Acquisition activities, including involving potential venture capitalist/investment bankers.

His most recent quotes “No doubt that old fashioned sales and marketing and plenty of hard work is a way to expand your business, but there is a short cut to growth, allowing the hard work reinforced with financial muscles to achieve desired growth through acquisitions. Merger, Acquisition, Partnership & Alliance are smarter and more efficient vehicles to grow an organization as compared to those super charged ambitious sales and marketing team efforts.”

His experience includes working with Corning Bio, Covance Biotechnology, Diosynth Biotechnology, Merck Bio-manufacturing and Fujifilm Biotechnology, not limited to but inclusive of working with Small Molecules API companies Capricorn pharmaceuticals, Boehringer Ingelheim Chemicals, Schering Plough, Organon/Akzo Nobel; and Ranbaxy Laboratories Limited, Punjab, India, where he began his career as Graduate Engineer Trainee.