Process & Analytical Development Specialist at Verismo Therapeutics

Philadelphia, Pennsylvania, United States -

Full Time

Start Date

Immediate

Expiry Date

07 Sep, 26

Salary

0.0

Posted On

09 Jun, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Process Development, Analytical Development, Scale-up, Tech Transfer, Quality by Design, Design of Experiment, cGMP Manufacturing, Cell Processing, Lentiviral Vector, Good Documentation Practices, SOP Authoring, Master Batch Records

Industry

Biotechnology Research

Description

PROCESS & ANALYTICAL DEVELOPMENT SPECIALIST Full-Time position Level: Specialist Location: On-site in Philadelphia PA Start date: Open WHY JOIN VERISMO? 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 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: We are seeking a passionate and skilled Process & Analytical Development Specialist to join our growing CMC team. In this role, you will play a pivotal role in advancing Verismo’s cell therapy products by supporting process and analytical development activities. Reporting directly to the Senior Manager of Process Development, you will contribute hands-on expertise to scale up processes, analyze data, and support tech transfers to external manufacturing partners. ESSENTIAL DUTIES & RESPONSIBILITIES: * Contribute to the setup and organization of Verismo Therapeutics’ process and analytical development capabilities. * Execute complex development studies (with multiple experiment sets) related to process development and scale-up, ensuring studies balance time and resources. * Apply Quality by Design (QBD) principals to process development, characterization, establish process parameters, and contribute to CMC regulatory filings. * Support next generation manufacturing processes and analytics for cell therapy and lentiviral vector * Author technical and scientific documents including but not limited to SOPs, Master Batch Records, study protocols and reports. * Ensure all documentation and reports are accurate, complete, and suitable for support of development, characterization, and regulatory approval of products. * PREFERRED EXPERIENCE & ABILITIES: * Experience in a cGMP manufacturing and/or QC setting or process and/or analytical development laboratory * Background in cell processing, scale up and tech transfer * Working knowledge of analytical tools commonly utilized in cell therapy manufacturing * Familiarity with quality by design (QbD) approaches and design of experiment (DoE) based studies * Ability to function in a dynamic environment. * Knowledge of GMP regulations as it pertains to best practices in cGMP manufacturing * Experience with Good Documentation Practices (GDP) * QUALIFICATION REQUIREMENTS: Bachelor’s degree in a scientific field with at least 2 years of relevant experience.

Responsibilities

Support process and analytical development activities to advance cell therapy products, including scale-up and tech transfers to external partners. Execute complex development studies and author technical documents such as SOPs and Master Batch Records.