Dynamic business leader, General Manager and Commercial Life Science Executive with experience on a global, regional, and country level. Launched new products, managed early and mature stage businesses, orphan drugs, and led a turnaround in a company that was experiencing declining revenue. Background includes P&L responsibility and oversight of Commercial, Medical Affairs and Clinical Operations functions. Talented relationship builder cross-functionally, cross-regionally and externally with key customers. Accomplished recruiter and developer of diverse talent. Strong track record in:

  • Sales
  • Marketing
  • Business Development
  • General Management

Seasoned biotech executive with 25 years of deep technical and manufacturing experience in advancing Biologics and Vaccine pipeline products through preclinical, Phase I-III clinical development, licensure and commercial manufacturing operations. Process Development/cGMP manufacturing/Validation/Tech Transfer experience with both Biotech companies and Big Pharma. Hands-on experience in the Design, Engineering, Validation, Start-up and Operation of multiple cGMP compliant manufacturing facilities in the U.S, Europe and India. Experienced in all aspects of Biopharm Drug Substance (DS) and Sterile Drug Product (DP) technical and manufacturing operations including large-scale mammalian cell culture bioreactor operations and Fill/Finish of licensed products. Planned and administered multi-million-dollar budgets with experience managing C-level and senior executive expectations in diverse cultural and multi-national settings to ensure effective direction, strategic/tactical planning, execution and results delivery. Areas of expertise include:

  • Process Development
  • Manufacturing Operations
  • Process Validations
  • Operational Excellence
  • Lean Manufacturing/Six Sigma
  • Technology Transfer

Highly enterprising, solutions-driven and accomplished life sciences executive offering a seasoned track record in value creation strategies, business development and sales management, in-/out-licensing and technology evaluation leading to chemical/biotherapeutic product partnerships and R&D access to the most innovative technology platforms. Possesses deep understanding of pharmaceutical drug discovery research coupled with a Ph.D. degree in molecular/cellular biology, with Oncology and Immunology/Inflammation specialization. Excels at driving successful domestic and/or international research collaborations, global partnerships, joint ventures, co-development/co-marketing alliances, outsourcing and licensing initiatives, and M&A transactions, as proven by an expansive deal sheet across pharma/biotech, government, and academic sectors. Proven strengths in originating key intellectual property and innovative business opportunities with Fortune 100 companies as well as biotech startups. Leverages strategic leadership by example to motivate and inspire teams at all levels. History of buy-side and sell-side negotiation experience resulting in over 700 executed contracts.

  • Strategic Planning/Execution
  • Alliances & Partnerships
  • Drug Discovery
  • Licensing & Technology

Results-oriented, data-driven executive with a history of career advancement and contributions in increasing commercial effectiveness, market share, and profitability for companies. Adept at analyzing, reporting, and transforming data into actionable recommendations and plans to help senior leadership execute quality decisions. Financial background includes supporting commercial prioritization and profitability mapping in Latin America. Bilingual in English and Spanish.

  • Commercial Strategic Planning
  • Business Intelligence
  • Sales Administration
  • Global Team Leadership
  • Multi-Country Operations Management
  • Market Segmentation
  • Pricing Strategies
  • Tender Negotiations
  • Sales Budgeting, Forecasting, & Reporting
  • New Product Launch
  • Sales Incentive Design
  • Lean Process Implementation

Strong track record of driving explosive growth, engineering innovative M&A and equity/debt deals, and laying the foundation for sustainable global expansion in medical device, diagnostics, and biopharma companies ($10M to $200M revenues). Trusted partner for CEO, key member of senior team, and advisor to Board of Directors on revenue growth strategy, business development initiatives, Wall Street investment and banking relationships, and potential liquidity opportunities. Achieved two successful IPO launches and rapidly grew both investor base and analyst coverage at three publicly owned enterprises.

  • Financial Reporting
  • SEC
  • SOX
  • Internal Controls
  • Analysis
  • Forecasting
  • Budgeting
  • ERP/Systems
  • Performance Metrics

Scientist with extensive experience in molecular biology, protein expression, cell line engineering, and protein design. Highly motivated, meticulous, proactive, and accountable with laboratory and interpersonal skills.

  • Protein Expression (E.Coli, Mammalian, BV, and Yeast)
  • Protein Purification (Batch Binding, HPLC)
  • Molecular Biology (Sequence Analysis, PCR, Cloning, Mutagenesis, and RT-PCT)
  • Cell Line Engineering (Gene Over Expression, siRNA, shRNA, and CRISPR-Cas9 based gene knock-down and knock-out)
  • Assay Development (WB, SDS-Page, IF, FACS, Octet Quantitation, Luciferase Assay, 2D-CFA, Kinase Activity Assay, PCR based methylation detection)
  • Lentiviral Based Gene Delivery and Viral Titer Determination
  • CRO Management (Gene to Protein and Cell Line Generation)

Manufacturing / Operations leader with over twenty years’ experience in global FDA regulated environments including biologics, vaccines, drug substance manufacturing and medical devices. Expertise includes upstream and downstream manufacturing of oral solid, semi-solid, liquids, pharmaceuticals and OTC/consumer products. A strong technical and analytical problem solver with a collaborative management style that practices team-based approaches to generate different visions and perspectives to ensure solvability of the most difficult problems. Successful track record of accountable technical leadership in:

  • Operations
  • Manufacturing
  • Project Management
  • Process Development
  • Optimization of Fermentation
  • Downstream Purification Processes
  • Process Validation
  • Technology Transfer of New and Legacy Processes

Manages strategic market research for resource constrained brand teams. Generated foundational patient journey insights for rare hematological conditions and neurological disorders, successfully integrating these insights into cross-functional planning processes. Integrated physician, patient, and payer learning to prioritize lifecycle indications and combined primary and secondary sources to build business cases for pipeline drugs. Executed global creative and message development research projects with complex country-level compliance requirements.

  • Coaches market research suppliers on better communication and insight generation.
  • Conducts multiple training workshops at leading Market Research suppliers; topics ranging from maximizing client interactions to strategic planning.
  • Conducts market analysis/forecasting for management consultants and investors.
  • Analyzes markets using secondary research and syndicated reports for a variety of markets including hormone replacement, glaucoma, incontinence, and sleep aids.

Influential and community-oriented Program Manager with an extensive background working side-by-side with underrepresented populations to support education, professional and personal development, and local resources. Builds and manages strong relationships with community partners to create networking opportunities, expand the recruitment selection, and drive program awareness. Strategically plans and delivers engaging year-round programming, speakers, and workshops. Cultivates a safe and positive environment for staff; fosters healthy communication within diverse teams. Fluent in English and Spanish. Able to keep calm during conflicts; skilled in communication, organization, and time management.

  • Strategic Planning and Vision
  • Workload Prioritization
  • Process Improvements
  • Advocacy Work
  • Cross-cultural Human Relations
  • Communication
  • Public Speaking
  • Project/Program Management
  • Community Engagement
  • Developing Relationships
  • Training
  • Team Leadership
  • Budget Management

Seasoned medical executive with worldwide expertise in directing clinical and non-clinical development programs and regulatory strategy for major pharmaceutical and biotechnology companies. Responsible for over 30 INDs and author of critical sections of successful US and European marketing applications for numerous products in addition to management of FDA Advisory Committee meetings. Strong record of team leadership and employee development. Respiratory experience includes filing 6 INDs for new chemical entities and management of significant programs in cystic fibrosis, nasal allergy, asthma, COPD and pneumonia from Phase 1 through 4. Significant experience in drug/device development. Additional therapeutic expertise includes:

  • NASH
  • Diabetic Neuropathy
  • Therapeutic Vaccines
  • Bacterial and Viral Vaccines
  • Antibiotics
  • Acute Coronary Syndromes
  • Percutaneous Coronary Intervention
  • Cardiovascular Surgery
  • Lipid Disorders
  • Deep Vein Thrombosis
  • Sexual Dysfunction
  • Small molecules with CDER and proteins/biologicals with CBER and the biologicals division of CDER.
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Phone: (610) 725-0290
Fax: (610) 975-0291
Email: info@ashtontweed.com

Ashton Tweed, Ltd.
314 S. Henderson Rd.
Suite G370
King of Prussia, PA 19406

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