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Accomplished Production leader with over 20 years of both hands-on experience in biotech manufacturing facilities and external management of CMOs. Oversight of full operational supply chain from APIs through Finished Good packaging. Technical experience with large and small molecules in addition to peptide manufacturing, mRNA production and LBPs, as well as sterile injectables, and solid oral dosage forms including capsule and tablet drug product formulation. Strong industry knowledge of both critical packaging components and brand artwork development and maintenance. Dependable and driven partner recognized by colleagues, peers and vendors as a detail-oriented, empathetic, and reliable collaborator who values and maintains relationships.Motivated and passionate employee with a demonstrated loyalty to long term strategy and values within the company and across partnerships. A creative thinker who appreciates efficiency and identifies areas of opportunity to reduce waste and improve yields.
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Vp, Head Of ProductionVedanta Biosciences, Inc. Jul 2023 - PresentCambridge, Ma, Us -
Senior Director, Clinical ManufacturingModerna Jan 2021 - Apr 2023Cambridge, Massachusetts, Us -
Head Of ManufacturingIronwood Pharmaceuticals Feb 2020 - Jan 2021Boston, Ma, Us• Work closely with entire supply chain of CMOs to ensure reliable compliant execution against production schedules to meet company and program goals.• Work closely with Regulatory and Quality departments to coordinate and lead key activities including packaging line trials, engineering batches, validation campaigns, process changes and scale-up.• Operationalize Ironwood’s strategic manufacturing plan by transferring the formulation process for IW-3718 Phase 3 to additional site to ensure sufficient commercial forecast capacity.• Initiate and manage campaigns for Feasibility and CTM batches at new DP CMO.• Lead transition of operational oversight for China LINZESS to partner. -
Associate Director, Commercial ManufacturingIronwood Pharmaceuticals Jun 2017 - Feb 2020Boston, Ma, Us• Operational oversight of API, DP, and external packaging CMOs.• Lead Quarterly Business review meetings with CMOs to ensure strong relationships with external partners.• Establish and publish KPIs and monitor vendor performance.• Served as key voting member of Joint Operation Committee with partner for Chinese approval and supply to support for launch.• Lead Artwork development and approval for Swiss AXULTA and China LINZESS.• Technical Transfer of packaging process for Hong Kong market.
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Sr Manager, Commercial ManufacturingIronwood Pharmaceuticals Sep 2015 - Jun 2017Boston, Ma, Us• Operational oversight of API and Drug Product CMOs.• Submission support for Filings in US, Switzerland, Hong Kong, China, and Japan.• Coordinated Ironwood brand trade dress for DUZALLO and ZURAMPIC.• Assist QA with vendor qualification audits.• Successful scale up of Drug Product and API processes.
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Manager, Commercial ManufacturingIronwood Pharmaceuticals Oct 2012 - Sep 2015Boston, Ma, Us• Operational oversight of Active Pharmaceutical Ingredient (API) CMOs • Technical expert and owner of change controls, deviations, and corrective actions.• Reviewer and approver of Master Batch Records, executed batch records, and batch summaries for commercial release• Track processing metrics for quarterly meetings
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Downstream Manufacturing LeadIpsen Jul 2010 - Oct 2012Boulogne Billancourt, Fr• Chosen for and obtained Six Sigma Green Belt with a project concentrated on improving batch record review time. Streamlined number of entries as well as organized test requests and ancillary documents. • Coordinated all process step activity, inclusive of glass-washing, part assembly, and sterilization of equipment in autoclave.• Lead Investigation for on the floor deviations and work to implement CAPAs as needed to improve the process.• Authored Master Batch Records (MBRs) and validation protocols for all purification processing steps. -
Senior Manufacturing AssociateIpsen Dec 2008 - Jul 2010Boulogne Billancourt, Fr• Lead purification group from the Harvest Clarification step, through the final dilution of Formulated Bulk of OBI-1(OBIZUR), a Hemophilia drug that was in Phase III clinical trials.• Chromatography column operation: packing, qualifying, cleaning, processing and maintenance for BPG 100 and 300s. SP, Q and DEAE chromatography steps performed on GE skids using Unicorn.• Oversight and operation of DNA filtration and Nanofiltration process. • Experience with validation protocols for new equipment installation and qualification. • Procurement of GMP materials and processing Equipment direct from manufacturers.
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Senior Manufacturing Associate, Cell CultureAmgen Mar 2006 - Oct 2007Thousand Oaks, Ca, UsSkilled in all phases of mammalian cell culture with a high level proficiency in the production and harvest steps. Main responsibilities included directly managing eight operators on a daily basis to ensure ENBREL production in a sterile and controlled environment.• Interacted cross-functionally with facilities and engineering departments on preventative maintenance and continuous improvement protocols by adhering closely to scheduling tools including Finite and Werum to ensure product safety. • Provided expert knowledge to close out over 100 Non-conformance, Corrective action/Preventative action investigations using Trackwise that assisted to streamline the process at both the Rhode Island and Colorado plants. • Revised and improved SOP’s and manufacturing procedures to ensure that instructions were clearly delineated and in GMP compliance, including more than 50% of the purification procedures for Denosumab during clinical trials. -
Manufacturing Associate, Cell CultureAmgen Mar 2004 - Mar 2006Thousand Oaks, Ca, Us
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Assisstant Swim CoachBoston University Sep 2001 - Sep 2003Boston, Ma, Us
Jason Ellow Skills
Jason Ellow Education Details
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Harvard Extension SchoolManagement -
Boston UniversityEngineering
Frequently Asked Questions about Jason Ellow
What company does Jason Ellow work for?
Jason Ellow works for Vedanta Biosciences, Inc.
What is Jason Ellow's role at the current company?
Jason Ellow's current role is VP, Head of Production.
What is Jason Ellow's email address?
Jason Ellow's email address is ja****@****hoo.com
What is Jason Ellow's direct phone number?
Jason Ellow's direct phone number is +140192*****
What schools did Jason Ellow attend?
Jason Ellow attended Harvard Extension School, Boston University.
What skills is Jason Ellow known for?
Jason Ellow has skills like Gmp, Biotechnology, Validation, Fda, Purification, Chromatography, Trackwise, Microsoft Office, Microsoft Excel, Technology Transfer, Sop, Lean Manufacturing.
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