Subject Matter Expertise

Technical Project Management

 

  • Identify scope & purpose to design a effective/efficient study

  • Step into on-going projects bringing focus and identifying gaps/gates to advance goals

  • Use industry knowledge and regulatory expectations to generate phase-appropriate timelines

  • Generate documents for study execution, including process maps, trackers, and meeting agendas/minutes

  • Support active internal and external communications

  • Work with teams to track progress and mitigate risks

CRO, CDMO, CTL
Research & Selection

 

  • Search, score, and rank international contract organizations based on client’s projects and priorities

  • Assist in generation of RFI, RFP, etc.

  • Initiate communications and review MSA’s and contracts

Technical Writing

 

  • Generation and review of technical documents needed by any scientific team

  • Documents include:

    • Control strategy documents

    • Standard Operating Procedures, including department logistics procedures and test methods

    • Technical protocols and reports, including development, qualification, validation, forced degradation, and comparability

    • Regulatory documents & presentations (Type-C / NMPA)

    • Journal articles

  • Examples

Assay Development and Assessment

  • Generate product analytical and stability profiles

  • Assess assay performance and provide feedback based on industry standards and regulatory expectations

  • Assist in assay development and validation in alignment with ICH, USP, and EP Guidelines

  • Develop and lead training courses

  • Knowledgeable of AD and QC laboratory design

  • Equipment selection and IOQ support

  • Operational readiness including logistics mapping

Analytical Laboratory Readiness

Protein Characterization

 

  • Identify critical quality attributes (CQAs) and appropriate assays for testing

  • Assist in LC method development and scale-up chromatography for fraction collection

  • Design of forced degradation studies to probe CQAs

  • Data interpretation and summary to develop holistic protein profile

  • Experience working in the protein biopharma space (mAbs, vaccines, gene therapy, VLPs)

Mass Spectrometry

 

  • Design MS method and studies for molecules ranging from peptides to intact protein complexes

  • Interpret MS results and incorporation into larger analytical profile

  • Work with CROs and core labs to facilitate MS method development

  • Recommend instrumentation and techniques based on desired end goals

Troubleshooting

 

  • Guide teams through root cause analysis, including relevant documentation

  • Design troubleshooting work instructions or procedures

  • Draft column/instrument operation and maintenance SOPs