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 channels. Comply with industry regulations, safety standards, and best practices in coaching and athlete development.Highlights of accomplishments in this role include:• 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 formulation excipients to ensure long-term storage of stable therapeutic proteins.Highlights of accomplishments in this role include:• 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 white papers to diverse audiences, enhancing comprehension/engagement.

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 skills, writing, and experimental design while supporting their professional development. Steered the approval processes for hormone replacement and gene therapy products, managing license applications and ensuring compliance.Highlights of accomplishments in this role include:• 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 shortening timelines.• 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, communicating information using SharePoint, and automating business processes with PowerApps.Highlights of accomplishments in this role include:• 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