Our client is a venture-backed, early-stage biotech company focused on the development of novel cell-based cancer therapies. The company is located in Gaithersburg, Maryland and has assembled a team of biotechnology professionals with expertise in biologics discovery, characterization, and development. Lead products will incorporate proprietary technologies that enhance tumor-specific killing by genetically engineered human immune cells.

Primary Objective

The candidate will bring to the role a strong understanding and demonstrated expertise with the latest bioanalytical technologies, method development/qualification/validation, and CRO outsourcing. His/her functions will include but are not limited to the external transfer and oversight of the development, qualification/validation, implementation of assays across a variety of technological platforms, and generation of documentation supporting regulatory filings. The successful candidate will be responsible for working across functional areas such as research, translational, clinical, regulatory, and manufacturing to enable critical decisions across the portfolio.

MAIN ACCOUNTABILITIES:

The main responsibilities will include but are not limited to:

• Provide management and accountability to the generation of bioanalysis and biomarker data for the support of pre-clinical and clinical safety and efficacy studies.
• Provide senior scientific leadership and set strategic direction of technology advancement.
• Manage development and qualification/validation of bioanalytical assays at CROs for PK, TK, immunogenicity and PD assays.
• Conduct and manage bioanalytical work at CROs to a high degree of quality and rigor, ensuring compliance with regulatory guidelines. Review and finalize SOPs, protocols, method validations, stability studies and bioanalytical reports that meet all applicable regulatory requirements.
• Work closely with clinical/nonclinical project teams and deliver bioanalytical data and prepare reports under agreed timelines. Also communicate results, progress and issues to project teams on a regular basis.
• Provide sample collection procedures, storage and transmission specifications for nonclinical and clinical protocols in preparation of lab manuals.
• Conduct comparability assessment (as needed) for any changes made to qualified/validated assays.
• Contribute to relevant bioanalytical sections of CSRs, and other regulatory and submission documents.
• Strong scientific and operational background in implementation of immunoassays/cell-based assays, molecular biology assays and target engagement assays
• Understanding of method validation, sample analysis, GLP, GCP requirements, ICH guidelines and FDA guidance.
• Interact closely with other team members to ensure that bioanalytical activities are prioritized appropriately and the deliverables are achieved in a timely manner.
  

Preferred Qualifications:

• PhD in Chemistry, Biochemistry, Pharmacology or Analytical Science with 10 or more years of pharmaceutical industry experience and a demonstrated technical leadership in bioanalytical techniques
• Experience working in the regulated bioanalytical space with an understanding of regulatory guidelines as well as laboratory experience with GLP regulations and GxP documentation.
• Proven ability to provide bioanalysis or biomarker expertise on programs/project teams for pre-clinical and clinical studies with a wide variety of techniques and technologies
• Strong background in the development and validation of immunochemical and cell-based assays for a variety of biotherapeutic molecules including new modality molecules.
• Excellent track record in PK, biomarker and immunogenicity testing in clinical trial settings, with proven experience of external vendor and/or sponsor oversight.
• Experience with IND and/or BLA submissions.
• Experience managing individual contributors.

Competencies:

• Detail oriented, exceptional documentation practices, technical writing and verbal communication skills.
• Demonstrated effective interpersonal, communication and negotiation skills for a wide variety of audiences, including senior R&D leaders
• Courage to lead and make tough decisions/strong influencing skills.
• Maintaining a disciplined approach, ensuring a relentless focus on quality, compliance, scientific rigor and operational excellence
• Excellent contingency planning and time management skills and demonstrated ability to manage several projects simultaneously.
• Possess strong problem solving and analytical skills and be an independent and creative thinker.
• Ability to navigate and be successful in a fast-paced, highly matrixed work environment.
• Must be detail oriented with strong documentation and organizational skills.