David Sek

Background

About David Sek

As a resourceful and driven professional, I have extensive experience in leading cross-functional teams in the research, design, and execution of scientific studies for the production of drugs.Being skillful at achieving corporate objectives, I have stabilized proteins and biotherapeutics while enabling successful clinical trials and commercialization. I hold a proven track record of navigating compliance processes while preparing submissions for regulatory authorities.My expertise lies in managing projects and crafting effective solutions to meet quality, timeline, and budget objectives. As an influential leader, I have transferred drugs between manufacturing sites to streamline facility operations.A few of my career highlights include: • Reduced delivery time of drug products to clinical facilities at Blueprint Biotherapeutic Advisors by revitalizing technical transfer processes.• Supported clinical studies and commercialization of products while creating CMC sections of regulatory documents, including INDs, BLAs, amendments, and query responses.• Delivered stable dosage forms for clinical studies at Pfizer, leading half a dozen projects from candidate selection to first-in-human studies.• Overhauled the drug product development roadmap, setting up a web-based platform with detailed guidelines and facilitating seamless candidate progression from selection to clinical studies. “Dave’s exceptional leadership in spearheading the BLA authoring for my team’s novel gene therapy product was truly commendable. His unwavering dedication, coupled with his innate ability to foster a collaborative environment, helped set a foundation for our team’s success. Dave’s remarkable adaptability, coupled with his strong leadership skills and approachable demeanor, make him an invaluable asset to any project or team. His contributions undoubtedly had a lasting impact.” - Christopher W, Senior Scientist, Pfizer