Philip Ross

About Philip Ross

Leader and Scientist | Analytical Development and Quality Control | CMC Strategy and Operational Excellence • 20+ years in pharmaceutical industry spanning large and small molecule development, with deep expertise in ASO and nucleic acid modalities. • 10+ years of managerial expertise, applying servant leadership principles to mentor staff, empower future leadership, and navigate through change and complexity.• Collaborative, flexible and authentic cross-functional team player and leader, with proven track record of successful CMC submissions in multiple global jurisdictions.• Extensive analytical development expertise in ASO modalities, regulatory starting materials, with additional background in small molecules, protein/ADCs.• Demonstrated success in advancing projects via CDMO and CRO models, plus complementary expertise gained from leadership roles within contract manufacturing/testing organizations. • Expertise in managing resources, budgeting, scenario planning and operational excellence to drive a complex portfolio of short and long-term technical and strategic analytical objectives.• Core member of site leadership teams driving operational excellence, workflow and process optimization, and technology innovation for an expanding pipeline- Modalities: Complex synthetic API, siRNA, ASOs, and small molecules, mRNA/LNP, conjugates-protein/ADCs, peptides- CDMO management: RFP, MSA through to final dispo and stability. Tech transfer, change management, Investigations, CAPA\'s, PPQ, comparability- CTL management: Long term successful relationships for method development, validation, routine testing and lifecycle management- Regulatory: Author, review of Analytical, QC, structure, impurities and DS/DP sections for IND, CTA, IMPD, NDA in multiple global jurisdictions. Cross-functional CMC strategy, meeting prep, responses to agency questions- CMC Strategy: DS, DP and starting material control strategy, setting and refining specifications, defining CQA\'s, reference standard, impurity ID, stability strategy, comparability and characterization- Technical: Expertise in methodologies for large and small molecules. Hands-on career experience across HPLC/UPLC multiple modes and detectors, LC-MS and LC-MS/MS including structure elucidation, RI, MALS/DLS, KF, electrophoresis, PCR, DNA sequencing, proteomics, CD, NMR, RAMAN, FTIR, biochemistry, biophysics, enzyme digestion- Strong industry publication record specializing in analytical chemistry, LC/MS, biochemistry, biophysics, small molecule drug development.

Experience

1. Senior Director, Analytical Development Quality Control Cmc

   Wave Life Sciences

   Feb 2021 — Present · Lexington, MA, US

   Build/grow Analytical/QC dept. supporting novel chemistry platform at GMP manufacturing facility.• CMC strategy, writing, review (IND, IMPD, NDA) for complex platform chemistry and analytics.• Oversee Analytical/QC workstreams at all CDMOs/CTLs for DS and DP IPC, release, and stability.• Support and experimental design of formulation development, in-use stability and forced deg studies.• Analytical SME in regulatory discussions, health agency responses and advisory board interactions.• Developed staff from bench scientists to high-performing managers and team leaders.• Oversight of on-site stability assets and internal/external protocols, testing, data analysis, expiry. • Expanded analytical technical capabilities, capacity, and compliance to support platform complexity. • Designed strategies for in-process, release, stability, characterization, and novel starting materials.• Internal and external quality event records (CAPAs, Change Controls, Deviations, OOS’s).• QC host/PoC for audits, inspections, responses, key business collaborations and KOL relationships.• Cross-functional collaborator in CDMO selection, RFP and proposal cycles leading to successful NPI.• Operations strategy: Resourcing, forecasting, technology, budget, compliance, culture.

Education

• Massachusetts College of Pharmacy and Health Sciences

  RAC, Regulatory Affairs and Health Policy

  2012 — 2013

• University of Delaware

  Doctor of Philosophy (PhD), Analytical Chemistry

• University of Waterloo

  Bachelor of Science (BSc), Physical Chemistry

Skills

• Product Development
• Drug Development
• Team Leadership
• Bioanalysis
• Chromatography
• Biologics
• Lc-Ms
• Cgmp Practices
• Life Sciences
• Regulatory Affairs
• High-Performance Liquid Chromatography (Hplc)
• Validation
• Mass Spectrometry
• CRO Management
• Oncology
• Biochemistry
• Business Development
• Biotechnology
• Project Management
• Infectious Diseases
• Protein Chemistry
• Hplc
• Proteomics
• Drug Discovery
• Good Laboratory Practice (Glp)
• Glp
• Adcs
• Analytical Chemistry