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.

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 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.

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

Trained as a medical anthropologist with a master’s degree in Library Science. Creates 100+ custom research reports a year to support evidence-based decisions across varying scientific and business functions globally. Curates weekly newsletters to help internal stakeholders stay up to date on key areas of interest. Initiated and continues to run a global awareness campaign, new hire communication plan, and strategic training programs to meet information needs across the company. Designed and implemented a knowledge management system that allows library staff to:

  • Manage research requests
  • Track metrics
  • Reduce time spent on duplicate requests
  • Distribute the workload across multiple time zones in real time

High-performing professional demonstrating visionary guidance and distinguished performance in oncology leadership, business development, and operational management. Disease expert and out-of-the-box thinker with strong business acumen, skilled in driving profitable growth and improving brand position and performance. Exceptional communicator and collaborator able to develop ongoing professional relationships with internal and external stakeholders.

  • Business Development
  • Partnership Cultivation
  • Medical Research
  • Strategic Planning
  • Relationship Building
  • Project Leadership
  • Operations & Sales Analysis
  • Scientific/Medical Presentations
  • P&L Responsibility
  • Market Expansion
  • Customer Relations
  • Process Improvement

Solution-focused senior-level executive with extensive experience in regulatory project management and strategic planning, responsible for building, developing and leading the Regulatory Affairs department for the evolving needs of the company. Possesses a comprehensive knowledge of global regulations to identify and implement effective regulatory pathways to deliver business goals and project objectives. A confident crisis-manager with excellent negotiation, communication and presentation skills to effectively perform gap analyses and assess value propositions to corporate stakeholders. Has a deep understanding of drug development processes (Phase 2 through post-approval) to drive, manage and coordinate eCTD submissions documents (IND/NDA, PREA/iPSP, REMS) to deliver successful results. Led initiatives to design and execute end-to-end global labeling development processes to ensure regulatory compliance of clinical programs.

  • Thorough Knowledge of U.S. FDA/EMEA Requirements
  • Works Effectively Across Multiple Therapeutic Areas
  • Core Member of Product Development Teams
  • Global Project Management/Operations
  • Identify Key Strategic Regulatory Drivers
  • Early to Late Stage Development Programs

A finance manager with experience in turnarounds, re-engineering, and consulting in finance, accounting, and reporting technologies for diverse clientele. Produced notable results in cost reduction, revenue gains, and profit margin increases. Led business improvement engagements that produced meaningful organizational change, strengthened ERP system implementations, and automated financial processes. Created BI tools to sharpen decision-making and optimize performance. Served as a trusted advisor and consultant.

  • Performance Optimization
  • Strategic Planning
  • Process Automation
  • Business Re-engineering
  • Financial Management
  • Business Intelligence
  • Change Management
  • Turnaround Expertise
  • Operations Leadership
  • Information Systems Analyst
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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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