David Sek Email & Phone Number

Andover, Massachusetts, United States

• Managed personalized training programs for athletes, coordinating schedules with training, work, and personal commitments. Maximize team cohesion and morale through conflict resolution strategies and open communication.
• Drove success for 20 clients training for endurance events, including swimming, cycling, running, triathlons, and ultra events by providing support in training methodologies, nutrition guidance, and race day strategies.
• Maintained a balanced budget and expanded client base while overseeing various business aspects, encompassing finances, website development, graphic design, clothing, and orders.
• Evaluated athletes' current fitness levels against performance goals, sustaining alignment and progress.

Andover, Massachusetts, United States

• Partner with cross-functional teams, leadership, and project management while directing operations from candidate selection to commercialization. Increase patient safety and minimize manufacturing costs, selecting.
• Reduced delivery time of drug products to clinical facilities by revitalizing technical transfer processes.
• Established container closure systems to fulfill the specific requirements of different phases of drug product development.
• Supported clinical studies and commercialization of products while creating CMC sections of regulatory documents, including INDs, BLAs, amendments, and query responses.o Tailored abstracts, posters, presentations, and.

Andover, MA

• Bolstered clinical studies and product launches by preparing technical and regulatory documentation, including IND and BLA submissions. Guided junior team members, presenting constructive feedback on presentation.
• Focused on regulatory authorship for CMC, primarily in protein therapeutics, formulating products for clinical trial suitability.
• Teamed up with a client partner to effectively navigate Phase II through process validation and BLA authoring, guaranteeing successful commercialization.
• Devised authoring strategies with an emphasis on end (IND/BLA) requirements, developing document templates in line with submission-ready standards while sustaining consistency across CMC Module 3 sections and.
• Delivered stable dosage forms for clinical studies, leading half dozen projects from candidate selection to first-in-human studies.

Andover, Massachusetts, United States

• Developed digital solutions for reforming and driving business processes across the organization. Teamed up with stakeholders and developers to implement custom solutions for visualizing data through Spotfire.
• Established Spotfire dashboards to envision and automate data monitoring, saving time and ensuring consistency in quality across programs.
• Improved departmental information sharing by transitioning the SharePoint environment into an interactive, responsive communications site.
• Collaborated with Software Developers to create over 20 custom PowerApp solutions, optimizing workflows and enhancing productivity.
• Governed a transformative project for Simulated Adaptive Learning, revolutionizing BTX's learning methods.

Bachelor Of Science - Bs, Chemistry

Master Of Science - Ms, Chemistry And Chemical Biology