Keith L. Email and Phone Number
A highly organized and well-rounded operations leader with extensive experience in clinical & commercial manufacturing; technology transfer; and continuous improvement to achieve maximum productivity for the manufacture of highly complex biologics. Adept at examining current business functions and implementing strategic initiatives that reduce costs and improve efficiency. Proficient at cross-training staff members to conduct various tasks, as well as ensuring all products are manufactured to the highest quality standards and in accordance with applicable regulations and procedures.
Larimar Therapeutics Inc.
View- Website:
- larimartx.com
- Employees:
- 25
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Vice President, Technical OperationsLarimar Therapeutics Inc. Oct 2019 - PresentBala Cynwyd -
Associate Director, Gto External BiologicsMerck Jun 2017 - Oct 2019West Point, PaResponsible for the oversight of technical operations at multiple external partners within the Merck Manufacturing network in support of various commercial products. Interfacing with internal and external stakeholders to ensure effective communication of issues and their timely resolution. Serving as subject matter expert within various product/project teams for the execution of technology transfer and commercial manufacturing of bulk drug substances. Serving as Technical Product Steward for commercial product with end to end (e2e) technical accountability to the value chain management team. -
Director Of ManufacturingOncobiologics Inc. Apr 2012 - May 2017Cranbury, NjDirected all aspects of drug substance manufacturing including facility design; technology transfer; upstream & downstream operations; procurement & inventory control and equipment validation. Collaborated with senior management and cross functional groups in order to develop manufacturing strategy for biosimilar candidates. Advised on process development activities in an effort to keep cost of goods (COGS) low in order to allow the biosimilar platform to maintain a competitive advantage in the marketplace -
Manager Technical ServicesPall Life Sciences Sep 2009 - Apr 2012Exton, PaManage the technical services group for the Mid Atlantic Sales Region. Responsible for all aspects of technical support to Pall Life Sciences’ customers, sales specialists, distributors, etc.. General functions included the management of quote preparation; filterability performance; report authorship; filter integrity test performance; and Pall Life Sciences’ fee-based field-services. -
Director Of Contract Biologics ManufacturingWuxi Apptec May 2006 - Jan 2009Philadelphia, PaDirect the purification, support services and sterile formulation / filling contract manufacturing operations within a three-suite, multi-product facility. Target clients were representative of all phases of drug development (Pre-IND Toxicology, Phases I, II, and III) with therapeutic and diagnostic indications. -
Biopharmaceutical Processing SpecialistPall Life Sciences Jun 2005 - May 2006Provided first-line product support for the Sales Team, targeting pharmaceutical and biopharmaceutical clients at the manufacturing and process-development levels. -
Manager, Downstream Biologics ManufacturingApptec Laboratory Services (Now Wuxi Apptec Jun 2003 - May 2005Managed the purification contract manufacturing operations within a newly constructed 75,000 ft2 five-suite, multi-product facility. Target clients were representative of all phases of drug development (Pre-IND Toxicology, Phases I, II, and III) with therapeutic and diagnostic indications. -
Supervisor, Downstream Support ServicesImclone Systems Jun 2001 - Jun 2003Initially hired as a Level II Operator to assist with commercial launch facility construction and startup activities for the manufacture of Erbitux®. Promoted to supervising all buffer and component preparation activities associated with Downstream Purification Operation at the completion of construction, technology transfer, initial validation and consistency batches (2002). -
Manufacturing Technologist, Group LeaderImmunomedics May 2000 - Jun 2001Responsible for the purification of cell-culture supernatants and ascites fluids, by utilizing Anion, Cation and Affinity Chromatography Methods, Tangential Flow Filtration, Final Formulation and Filling, resulting in a monoclonal antibody and diagnostic product for clinical and commercial use.
Keith L. Education Details
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Biology
Frequently Asked Questions about Keith L.
What company does Keith L. work for?
Keith L. works for Larimar Therapeutics Inc.
What is Keith L.'s role at the current company?
Keith L.'s current role is Vice President, Technical Operations at Larimar Therapeutics, Inc..
What schools did Keith L. attend?
Keith L. attended Muhlenberg College.
Who are Keith L.'s colleagues?
Keith L.'s colleagues are Alison Gillespie, David Chu, Sarah Rose Moore, Amanda Lopuski, Azriel Schmidt, Susan R. Ostrander, Andrea Ong.
Not the Keith L. you were looking for?
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Keith Smith
Edmonds, Wa1kaplan.edu2 +195451XXXXX
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Keith L
Hr Executive: Enterprise Talent Development, Leadership Development, And Organizational DevelopmentRockville, Md1savantage.net1 (301) 2XXXXXXX
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