Chief Technical Operations Officer at Redpin Therapeutics
Greater Boston Area
Principal Scientist @ Amgen From 2000 to 2006 (6 years) Staff Scientist @ ICOS From 1998 to 2000 (2 years) Chief Technical Operations Officer @ Redpin Therapeutics Responsible for all aspects of process, analytical and formulation development and cGMP manufacturing to advance Redpin's portfolio of chemogenetically controlled gene therapy programs. Redpin is developing uniquely controllable gene therapies...
Principal Scientist @ Amgen From 2000 to 2006 (6 years) Staff Scientist @ ICOS From 1998 to 2000 (2 years) Chief Technical Operations Officer @ Redpin Therapeutics Responsible for all aspects of process, analytical and formulation development and cGMP manufacturing to advance Redpin's portfolio of chemogenetically controlled gene therapy programs. Redpin is developing uniquely controllable gene therapies to address diseases of the central nervous system. Vice President and Head, Manufacturing @ CRISPR Therapeutics Responsible for cGMP manufacturing operations for all of CRISPR’s product portfolio including hemoglobinopathies (β-thalassemia and sickle cell disease) and immuno-oncology (focused on CRISPR/Cas9-edited allogeneic CAR-T cell therapies). Included internal manufacturing facility design and setup, oversight over multiple CMOs and MS&T functions. CRISPR Therapeutics is a leading biopharmaceutical company created to translate CRISPR/Cas9, a breakthrough gene-editing technology, into transformative medicines for serious human diseases. From 2019 to 2019 (less than a year) Cambridge, MASenior Vice President, Process Development and Manufacturing (KBI) and CSO (JSR LifeSciences) @ KBI Biopharma Contract process development and manufacturing for biopharmaceuticals. Created, hired and led a 200 FTE organization with cell line development, upstream and downstream process development and analytical methods development functions. Development of robust manufacturing processes for biopharmaceutical production through phases ranging from proof-of-concept to early-stage clinical trials and commercial launch. Execution of process characterization and scale-down validation studies in support of licensure filings. Expanded manufacturing in dedicated suites for mammalian cell culture (3x2000L scale) towards clinical production and commercial launch. Grew organization from ~ 20 to > 200 FTEs in various functional areas. Organization supported 12-14 new IND filings every year in addition to late-stage development and commercial launch.Scientific support for development and acquisition of novel bioprocess materials and technologies for JSR LifeSciences (KBI's parent company). From 2015 to 2018 (3 years) Raleigh-Durham, North Carolina AreaVice President, Process Development & Manufacturing @ KBI Biopharma Built a cutting-edge biopharmaceutical process development and manufacturing team from the ground up. Grew team from ~ 20 FTEs to > 200 FTEs supporting both process & analytical development and clinical/commercial launch manufacturing to support 12-14 IND filings annually in addition to several late-stage development and commercial launch programs. Achievements include a first-ever PPQ campaign in 2018. A number of leading publications and technologies have come out of the process development team. From 2011 to 2015 (4 years) Raleigh-Durham, North Carolina AreaDirector, Manufacturing Sciences & Technology @ Bristol-Myers Squibb Started and established the MS&T functionality to focus on commercialization of all biopharmaceuticals at BMS. Activities include process characterization, process validation, tech transfer and CMC regulatory interface for late-stage biopharmaceutical manufacturing processes. Post-commercial product support.Key accomplishments include FDA and EMA approval for Yervoy and Nulojix in 2011. From 2006 to 2011 (5 years) Vice President & Head, Biologics Process Development @ Shire Biologics development for all of Shire's biopharmaceutical programs across Lexington, MA and Vienna, Austria sites. Includes all aspects of drug substance and drug product process development from pre-clinical to commercial. Functions include upstream process development, downstream process development, formulation development, process analytical support, drug product process development, pilot plant operations and CMC product stewardship. From 2018 to 2019 (1 year) Greater Boston Area
Amgen
Principal Scientist
2000 to 2006
ICOS
Staff Scientist
1998 to 2000
Redpin Therapeutics
Chief Technical Operations Officer
CRISPR Therapeutics
Vice President and Head, Manufacturing
2019 to 2019
Cambridge, MA
KBI Biopharma
Senior Vice President, Process Development and Manufacturing (KBI) and CSO (JSR LifeSciences)
2015 to 2018
Raleigh-Durham, North Carolina Area
KBI Biopharma
Vice President, Process Development & Manufacturing
2011 to 2015
Raleigh-Durham, North Carolina Area
Bristol-Myers Squibb
Director, Manufacturing Sciences & Technology
2006 to 2011
Shire
Vice President & Head, Biologics Process Development
2018 to 2019
Greater Boston Area
What company does Abhinav Shukla work for?
Abhinav Shukla works for Amgen
What is Abhinav Shukla's role at Amgen?
Abhinav Shukla is Principal Scientist
What industry does Abhinav Shukla work in?
Abhinav Shukla works in the Pharmaceuticals industry.
Who are Abhinav Shukla's colleagues?
Abhinav Shukla's colleagues are Wesley Dobbs, Tripti Gaur, Sonal PhD, Maureen Connelly, Jaya PhD, Lawrence Klein, Demetrios Kalaitzidis, Kala Subramanian, Gamze Karaca, and Sorana Ailinca-Luchian
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