Analytical Development Lead

Valid8 Financial, Inc.; Philadelphia (Philadelphia County); On-site; USD 80,000 - 120,000; Full time

Job summary

An established industry player is seeking an Analytical Development Lead to drive innovation in cell therapy. This pivotal role involves developing and validating analytical methods, ensuring the accuracy and robustness of lab processes, and providing essential support to R&D projects. The ideal candidate will have extensive experience in biochemistry and bioanalytical techniques, along with a collaborative mindset to manage cross-functional teams. Join a passionate team dedicated to advancing life-changing therapies for cancer patients, where your contributions will significantly impact the future of healthcare. Embrace a culture that values work/life balance and career development.

Qualifications

• 5+ years of experience in analytical development in cell and gene therapy.
• Expertise in biochemistry and bioanalytical techniques required.

Responsibilities

• Develop and validate analytical methods for cell therapy characterization.
• Lead technical documentation and ensure compliance of analytical methods.

Skills

Analytical Development

Biochemical Techniques

Biophysical Techniques

Bioanalytical Techniques

Cell Processing

Leadership

Troubleshooting

Project Management

Education

Master’s degree in a related scientific field

Tools

FlowJo

Prism

JMP

Job description

Our team is small but driven, with the single focus of bringing life-changing cell therapies to patients with cancer. With a solid pipeline built around a novel KIR-CAR platform, our technology has found a way to circumvent the barriers in solid cancer where other CAR therapies have limited success. KIR-CARs eliminate the artificial chimeric constructs within T cells and instead use a natural NK-cell derived signaling system. This system is potent against both hematologic and solid tumors, and in preclinical models is superior to current CAR-T in conferring long-term sustained anti-tumor function to overcome the challenges posed in solid cancer. We have a strong semi-virtual team for CMC, clinical product manufacture, and clinical investigators already established and moving fast to bring KIR-CARs to patients in need.

Our company is comprised of individuals who each bring something unique to the table and are valued for their contributions. Our culture is based on the concept of ‘love what you do’ and the dedication that builds a team where people do their best and support one another. Because we believe our people are our greatest asset, career development is an important aspect of our investment in our team and we encourage work/life balance.

About the Position:

Verismo Therapeutics is seeking an experienced Analytical Development Lead to join our team. The ideal candidate should have an understanding of biochemical, biophysical, and bioanalytical techniques and cell processing/engineering methods. You will be responsible for developing, optimizing and validating analytical methods for cell therapy characterization, ensuring the robustness and accuracy of lab processes, and providing technical support to research and development projects.

• Develop, optimize, and validate automated and manual analytical methods such as ELISA, PCR, flow cytometry, potency and other relevant assays for cell therapy and viral vector release and characterization.
• Develop standard operating procedures (SOPs) for process- or product-related development, optimization and characterization activities.
• Assess and integrate existing cell processing/engineering methodologies and/or technologies and design methodologies/experiments to support cell therapy development.
• Lead technical documentation efforts associated with laboratory experiments, activities, validation studies and maintenance processes.
• Ensure the robustness, accuracy and compliance of analytical methods, processes and activities.
• Lead tech transfer of assay to relevant external partners.
• Track and report analytical development status and progress to management.
• Troubleshoot and solve analytical problems, and propose technical solutions.
• Participate in meetings and manage active communication with external partners and stakeholders.
• Assist in authoring and reviewing regulatory filings as needed.

Preferred Experience & Abilities:

• Demonstrated experience leading analytical development efforts in cell and gene therapy or biopharmaceutical environments.
• Familiarity with regulatory expectations for analytical methods supporting IND-enabling and clinical-stage programs.
• Hands-on experience with analytical method qualification/validation and technology transfer.
• Expertise in designing and optimizing multiparametric assays for complex biologics, including potency and identity assays.
• Experience working in cross-functional teams involving R&D, Quality, and Manufacturing.
• Proficiency in data analysis tools and software (e.g., FlowJo, Prism, JMP, or equivalent).
• Ability to manage and prioritize multiple projects in a fast-paced, evolving environment.
• Strong leadership skills with the ability to mentor junior scientists and contribute to team development.
• Familiarity with automated liquid handling platforms and high-throughput screening tools.
• Collaborative mindset and experience communicating technical findings to both scientific and non-scientific stakeholders.

Qualification Requirements:

• Master’s degree in a related scientific field (e.g. biochemistry, molecular biology, cell biology, bioengineering, etc.)
• Minimum of 5 years of relevant experience in a laboratory environment.
• Expertise in biochemistry, biophysical, and bioanalytical techniques as well as cell processing/engineering methodologies.
• Ability to troubleshoot analytical instrumentation, develop automated liquid handling techniques, and design and execute experiments.
• Strong document writing, technical problem solving, and scientific presentation skills.
• Working knowledge of laboratory safety and good laboratory practices.
• Experience with ELISA, PCR, flow cytometry, FACS, potency and/or other relevant cell therapy and vector assays.
• Excellent communication, interpersonal, and organizational skills.

To apply, please submit your most recent CV. We also recommend including a cover letter and your LinkedIn profile URL as part of your application.