David Kroon Email & Phone Number

David Kroon is a President at Rotem Inc. He possess expertise in validation, capa, gmp, change control, manufacturing and 23 more skills. Colleagues describe him as "Dave Kroon has been a key person in the development of PET products in my organization. When we first entered this field, he utilized outstanding networking and interpersonal skills to build a large list of important contacts in the PET industry. Through this, linkages were made that allowed the organization to quickly educate itself and establish expertise. His role quickly evolved into CMO Manager for PET Development. Dave established a list of key producers, visited more than 25 PET production sites to make technical and capability assessments, participated in several site audits, and generally made major contributions to PET manufacturing site selection. He further contributed to the development of a site qualification process, owing the development of qualification protocols. Once sites were selected, Dave functioned as the project manager, coordinating weekly teleconferences and driving the establishment of plans to qualify and to remediate any issues encountered. Ultimately more than 20 sites were qualified. Once a site was qualified, production of clinical supplies became the focus. The delivery of doses to the clinic required close coordination between the Development and Clinical departments. Dave was the key representative for Development in a complicated coordination of logistics. Due to site availability impacts from illness, vacation, and other issues, it became common to move dose production sites to insure backup production. A key strategy Dave implemented was flying doses to cover sites that were unavailable. He contacted and established the process for coordinating pickup and delivery of doses, ultimately achieving an outstanding record of dose delivery. In addition to the above efforts, it is not uncommon for dose production to have technical issues that require investigations. In his role, Dave was frequently the first point of contact, triaging the issue by identifying and engaging the appropriate technical person/area from Development to interface with the technical staff at the production site. Dave was also a key participant in the identification and qualification of key suppliers for reagents and components for product production. He again functioned as the project manager, as well as, coordinating development of master production records and review of completed batch records. In addition, he functioned as a key interface to the Quality organization in our company, aligning support from Quality Assurance for review and approval of production records, investigations and CAPAs. Dave has consistently demonstrated a passion for his work. He has routinely identified creative solutions to issues and project needs that have saved time, money and resources. His dedication included 24/7 availability to support production sites, and frequent long hours coordinating last minute dose production and distribution. There is no doubt Dave has been an outstanding contributor to our efforts and accomplishments. " and "David has led the qualification of 25 contract manufacturing sites over the past 6 years, leading to an uninterrupted supply of clinical materials. David has accomplished this with great creativity and entrepreneurial spirit. He is highly effective in building and directing teams, and in cultivating positive vendor relations. His leadership and insight go well beyond his direct area of responsibility, benefiting our entire Pharmaceutical Development effort. I highly recommend David for management of contract manufacturers and for leadership of development projects in general."

Listed skills include Validation, Capa, Gmp, Change Control, and 24 others.

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  President

  Rotem Inc

  Boston, Ma, Us