Daniel Lavin Email and Phone Number
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Accomplished pharmaceutical engineering director with over 30 years experience leading development, design, construction, commissioning, validation, and operation of biologics manufacturing facilities.Provided daily technical support for cGMP biologics manufacturing including troubleshooting, helping determine and implement validation strategy and quality-based solutions, and implementing process and equipment improvements.Built and managed technical groups responsible for process development, scale-up, and technology transfer of cGMP processes within biotechnology companies.Specialties: • Program management• Process equipment & facility design, construction, start-up, and qualification• Process development, technology transfer & managing manufacturing operations• Managing production of therapeutic product as owner’s representative at a CMO• Managing projects including defining scope, developing manhour and cost estimates and execution schedules, allocating resources, completing deliverables on budget and on time, and managing clients.Director Engineering Technical ServicesLION – LinkedIn Open NetworkerConnect with me using:► daniel.lavin1@gmail.com ◄ 617-512-1495
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Biopharma Sme - Biopharma And Life SciencesExyteAlbuquerque, Nm, Us -
Biopharma Sme - Biopharma & Life SciencesExyte Dec 2022 - PresentStuttgart, Baden-Württemberg, De -
Director Program ManagementCuria (Formerly Amri) Jan 2022 - Nov 2022Albany, Ny, UsLed a $110M facility expansion program involving the design, installation, start-up, qualification and licensure of two new isolated filling lines. Created an integrated project execution strategy and managed the overall execution of the program. Led cross-functional project members including engineering, facilities, quality assurance, regulatory and compliance, finance, procurement, technical operations, validation, and operations personnel to ensure all aspects of the program were captured and progressing on schedule and within budget. -
PrincipalBioprocess Design And Technology Management Sep 2018 - Dec 2021Provided consulting services in engineering and qualification of processes, equipment, and facilities.
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Sr Director, Engineering And MaintenanceNantkwest May 2017 - Jul 2018Culver City, Ca, UsDirected Engineering, Maintenance, and Validation for three facilities, two of which are focused on clinical production and one focused on process development. Managed design, procurement, construction, and start-up of equipment and facility in new 20,000SF clinical production facility in which novel technologies are used to produce live cells for cell therapy. New facility included production suites, QC laboratories, clean utilities, plant utilities, warehouse, kitchen, and offices. Directed ten process and validation engineers and maintenance technicians. -
Associate Director, Process Engineering | Technical ServicesShire (Formerly Baxalta And Baxter Bioscience) 2010 - 2017Deerfield, Illinois, UsResponsible for all activities involved with Process in new facility project including managing process engineering, process control systems, and technical services groups. Managed design, procurement, fabrication, construction, start-up, commissioning, and qualification of all process equipment and associated piping, instrumentation, and control systems ($100MM) in 115,000SF multi-product plasma processing commercial manufacturing building. Managed twenty-two process and automation engineers and scientists, directed activities of engineering design firm, and co-directed activities of construction management firm. -
Senior Principal Process EngineerParsons 2004 - 2010Chantilly, Virginia, Us• Process Lead for design and construction of pharmaceutical production facilities.• Commissioning, Qualification, and Validation Lead for commercial manufacturing facilities.• Lead Consultant for compliance evaluation and renovation of biopharmaceutical production facilities. -
Director Biopharmaceutical Technology | EngineeringProcess Facilities Inc (Pfi) 2002 - 2004• Owner's representative overseeing all aspects of preliminary engineering design of upstream and downstream processes for cell culture production facility.• Developed process simulation of cell culture production facility with asymmetric downstream processing trains. Utilized process scheduling software to optimize design of purified water and WFI generation & distribution systems.• Developed conceptual design of microbial process for feasibility study of insulin production including operational schedule, detailed equipment list, and project cost & schedule estimates.
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Director Process Development | Technical ServicesAcusphere, Inc. May 2000 - Dec 2001UsManaged projects to design, fabricate, commission, and validate complex custom aseptic processing equipment. -
Manager Process EngineeringProcess Facilities Inc (Pfi) 1996 - 2000Developed and managed a new business unit focused on carrying out projects for pharmaceutical companies.• Developed production facility strategies including comparing timeline and cost projections for building new facility, purchasing and renovating existing facility, and utilizing contract manufacturer.• Managed production of clinical trial material at CMO, including technology transfer, management of daily activities, budget and schedule, evaluation of cGMP manufacturing documentation, and coordination of contract negotiations.
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Research ScientistRepligen Corporation 1992 - 1995Waltham, Ma, UsLed a group responsible for developing, scaling up, and transferring to manufacturing complete downstream processes for microbial expressed products, supervising six scientists.• Transferred cGMP processes to clinical manufacturing including writing batch records, starting up equipment, training manufacturing personnel, and troubleshooting production operations.• Directed team that developed a complete microbial commercial manufacturing process resulting in fivefold reduction in cost of goods.
Daniel Lavin Skills
Daniel Lavin Education Details
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Bucknell UniversityChemical Engineering -
University Of MinnesotaBiochemical Engineering
Frequently Asked Questions about Daniel Lavin
What company does Daniel Lavin work for?
Daniel Lavin works for Exyte
What is Daniel Lavin's role at the current company?
Daniel Lavin's current role is BioPharma SME - BioPharma and Life Sciences.
What is Daniel Lavin's email address?
Daniel Lavin's email address is da****@****ail.com
What is Daniel Lavin's direct phone number?
Daniel Lavin's direct phone number is +161751*****
What schools did Daniel Lavin attend?
Daniel Lavin attended Bucknell University, University Of Minnesota.
What skills is Daniel Lavin known for?
Daniel Lavin has skills like Gmp, Technology Transfer, Process Engineering, Validation, Biotechnology, Capa, Process Simulation, Pharmaceutical Industry, Engineering, Biopharmaceuticals, Chemical Engineering, Commissioning.
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