Daniel Lavin Email & Phone Number

Albuquerque, Nm, Us

Stuttgart, Baden-Württemberg, De

Albany, Ny, Us

Led 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.

Provided consulting services in engineering and qualification of processes, equipment, and facilities.

Culver City, Ca, Us

Directed 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.

Deerfield, Illinois, Us

Responsible 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.

Chantilly, 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.

• 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.

Us

Managed projects to design, fabricate, commission, and validate complex custom aseptic processing equipment.

Developed 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.

Waltham, Ma, Us

Led 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.

Bs, Chemical Engineering

Biochemical Engineering