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David Sunseri, Ph.D. is listed as CEO | CMC Drug Development | Aseptic Manufacturing | Parenterals | Inhalation | Medical Devices | Analytical Development at Stealth biopharmaceutical company, based in Nashville, Tennessee, United States. AeroLeads shows a work email signal at haemtech.com and a matched LinkedIn profile for David Sunseri, Ph.D..
David Sunseri, Ph.D. previously worked as Chief Executive Officer at Stealth Biopharmaceutical Company and President at Sunseri Consulting And Management, Llc. David Sunseri, Ph.D. holds Ph.D., Analytical Chemistry from Florida State University.
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AeroLeads found 1 current-domain work email signal for David Sunseri, Ph.D.. Compare company email patterns before reaching out.
Chief Executive Officer with over 20 years in pharmaceutical product development, analytical development, and internal and external clinical and commercial manufacturing. Pharmaceutical and contract development executive leading CMC projects at large public as well as private organizations. Full P&L responsibilities for private organizations and large cross-functional pharmaceutical projects. Proven executive and operational leader with a strong reputation for delivering exceptional results to shareholders and owners by improving right first time and lowering cost of goods. Key areas of strength include:Strategic Leadership: Proven leader with demonstrated ability to develop straight-forward readily executable strategies in both public and private organizations in the pharmaceutical industry. Built CDMO from beginning and sold for double digit multiple of EBITDA in 2.5 years. Demonstrated successful regulatory strategies for IND and NDA filings for small molecule therapies in all phases of development. Exceptional communication skills with internal and external stakeholders.Operational Excellence: Successful project implementations of multi-million dollar capacity expansions and greenfield projects. Successfully scaled up operations over 4x with less cost and resources. Improved right first time for manufacturing and analytical testing from <10% to >90% in 18 months. Delivered 100% clinical trial material on time. Saved $4M annually by improving manufacturing processes.General Management: Built high performing teams and organizations. Demonstrated track record of increasing right first time and encouraging continuous improvement in scientific and business functions. Successfully built relationships with clients and stakeholders to increase repeat business across international cultures.P&L Responsibility: Overall annual P&L responsibilities for large pharma products with >$100M in spend with ~$1.5B in revenue. Responsible for >$10M entire organizational budgets at private pharmaceutical and CDMO organizations.dsunseri@gmail.com+1-908-917-5557
Listed skills include Pharmaceutical Industry, Drug Development, Gmp, Glp, and 13 others.
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A career timeline built from the work history available for this profile.
CEO of stealth biopharmaceutical company with assets ranging from oncology to dermal inflammatory diseases. The company will shortly begin Series A fundraising efforts.
A single member LLC providing consulting and management services to pharmaceutical, biopharmaceutical, and contract development and manufacturing organizations. The company can provide due diligence for VC/PE firms for mergers and acquisitions. Current projects include providing strategic direction for cell therapy in preclinical development and CMC and clinical development strategy for 505(b)(2) asset.
Essex Junction, Vermont, Us
Prolytix, formerly Haematologic Technologies, delivers large molecule and protein chemistry expertise to accelerate your drug development. With more than 30 years of experience, our accessible and attentive team identifies and solves your large molecule product challenges from routine to complex. When it’s time to choose a partner for your next biotherapeutic project, go with the pro — Prolytix. To learn more about our expertise, services, and products, visit GoProlytix.com.
Nashville, Tennessee, Us
Following the acquisition by Oak HC/FT, retained to advise CEO during the transition.
Nashville, Tennessee, Us
Reported to Ownership of company and responsible for all divisions in the company including research, development (analytical, formulation, regulatory), quality, support functions (supply chain and engineering) and finance. Directed the strategic direction of building a company to provide one-stop shop services to pharmaceutical clients. Selected accomplishments include:• Sold company after 2.5 years from start for double digit multiplier of EBITDA• Developed and executed strategic plans to build company from beginning to acquisition target• Accountable for product cost drivers, overall cost of ownership, risk management, compliance, and ongoing cost improvement for all products; negotiated multi-year multi-million dollar contracts• Full P&L responsibilities with ~$10M annual budget and over $12M in revenue
Nashville, Tennessee, Us
Framingham, Ma, Us
Reported to Chief Operating Officer and responsible for all CMC functions. Other positions included Vice President, Manufacturing and Director, Manufacturing. Delivered 100% of clinical trial material on time so no patients ever missed a dose. Increased capacity and improved right first time with minimal capital investment. Led analytical development, quality control, engineering operations, supply chain, formulations, and facility operations and managed $10M operating budget. Selected accomplishments include:• Directed all clinical manufacturing activities at Berg’s Nashville site related to Berg’s small molecule investigational drug products• Led clinical manufacturing process improvement activities to increase output by 4x, reduced overall FTEs, while lowering overall costs by 20%• Directed all outsourced activities related to the manufacture of Berg’s small molecule investigational drug products, including the identification, selection and oversight of Contract Manufacturing Organizations (CMOs) and other key suppliers• Introduced and led implementation of new Quality Management System across the organization for phase appropriate compliance• Identified and facilitated the resolution of manufacturing, supply chain, analytical and quality issues that adversely affected performance goals
Rahway, New Jersey, Us
Reported to Head of External Manufacturing, Drug Delivery Systems. Other position included Relationship Manager with similar responsibilities. Had responsibility for inhalation and women’s health medical devices for US, EU, and ROW. Selected accomplishments include:• Owner and primary point of contact for all business and operational activities between Merck and global external partners for Drug Delivery Systems/Applicators, medical devices, and specialty materials in the Women’s Health Business – Experienced in cGMP and ISO 13485• Managed day to day operational partnership with external partners for supply of products from including manufacturing and analytical activities and negotiating of long term multi-million dollar contracts (including capital spend and pricing) with external partners• Budget responsibilities • Identified and lead for Lean and Six Sigma Laboratory and Manufacturing Right-First-Time and COGs reduction initiatives
Rahway, New Jersey, Us
• Analytical Strategic Leader for 5-7 concurrent small molecule sterile injectable products• Analytical Womb to Tomb Project Leader in oncology and cardiovascular with full Project Management and budget responsibilities including timelines and technical expertise for cross functional team of drug substance, drug product, analytical, regulatory, and CMC
Kenilworth, New Jersey, Us
Served as Project Leader of team of 8 project managers for Global Laboratory R&D Harmonization across 8 international sites with separate business units impacting over thousands of users, responsible for global process improvement, efficiency gains, and reducing the cost of compliance with budget responsibilities.
Kenilworth, New Jersey, Us
Analytical support of Asmanex DPI (approved March 2005) and other joint ventures with Novartis to develop MDI/DPI combination products
Quick answers generated from the profile data available on this page.
David Sunseri, Ph.D. works for Stealth biopharmaceutical company.
David Sunseri, Ph.D. is listed as CEO | CMC Drug Development | Aseptic Manufacturing | Parenterals | Inhalation | Medical Devices | Analytical Development at Stealth biopharmaceutical company.
AeroLeads has found 1 work email signal at @haemtech.com for David Sunseri, Ph.D. at Stealth biopharmaceutical company.
David Sunseri, Ph.D. is based in Nashville, Tennessee, United States while working with Stealth biopharmaceutical company.
David Sunseri, Ph.D. has worked for Stealth Biopharmaceutical Company, Sunseri Consulting And Management, Llc, Prolytix, August Bioservices, Llc, and Berg Health.
You can use AeroLeads to view verified contact signals for David Sunseri, Ph.D. at Stealth biopharmaceutical company, including work email, phone, and LinkedIn data when available.
David Sunseri, Ph.D. holds Ph.D., Analytical Chemistry from Florida State University.
David Sunseri, Ph.D. is listed with skills including Pharmaceutical Industry, Drug Development, Gmp, Glp, Technology Transfer, Lc Ms, Analytical Chemistry, and Validation.
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