Sr. Scientist

Real; Cambridge (MA); On-site; USD 140,000 - 210,000; Full time

Job summary

Real is seeking a Senior Scientist in Cambridge, MA to lead the optimization of cell therapy manufacturing processes from design through late-stage development.

You will apply Quality by Design and multivariate methods, develop GMP-compliant workflows, and collaborate cross-functionally with internal and external partners to advance clinical and commercial programs.

Qualifications

• Strong experience in cell therapy process development using multivariate design (Quality by Design).
• Experience with JMP software or equivalent.
• Demonstrated cell production technology development in cell therapy contexts.
• MS Office proficiency in a fast-paced environment.

Responsibilities

• Develop and optimize cellular therapy manufacturing processes using primary mammalian cells and stem cells.
• Implement Design of Experiments and statistical analyses to drive material/process decisions.
• Support later-stage clinical and commercial manufacturing process development.
• Pursue experience with late development stages of cell manufacturing.
• Assist technology transfers, quality documents, regulatory filings, CMOs/CROs.
• Collaborate with internal/external partners to evaluate new process technologies.
• Stay updated on cell therapy manufacturing trends and recommend improvements.
• Author SOPs, protocols, technical reports, and regulatory documents.
• Comply with health, safety, and environmental policies.

Skills

Cell therapy process development

Quality by Design

JMP software

MS Office

Cross-functional collaboration

Education

PhD in Life Sciences

Job description

The Senior Scientist, Cell Therapy Process Development position plays a key role in implementing and optimizing processes related to the development of cellular therapies involving primary cells and stem cells. This individual will work independently to optimize cell culture manufacturing process using Quality by Design principle and multivariate approaches. This position will develop and integrate cell culture platforms into a GMP compliant workflow for late-stage development. We are seeking an individual with the breadth of professional experience and drive to work effectively with both internal and external partners in a highly matrixed and cross-functional organization.

KEY RESPONSIBILITES

• Development and optimization of cellular therapy manufacturing process involving primary mammalian cells and stem cells
• Perform process development studies by implementing Design of Experiment approaches, and statistical analysis to make data driven decisions around implementation of new materials or process.
• Develop, optimize and refine cell manufacturing processes for clinical and commercial manufacturing.
• Proactively pursues experience with later development stages of cell manufacturing processes for clinical and commercial manufacturing.
• Supports technology transfers and quality documents, regulatory filings, interactions with CMOs and CROs.
• Participates in internal and external collaborations to evaluate and implement new process technologies.
• Maintains up to date knowledge of cell therapy manufacturing trends and provides recommendations regarding manufacturing process improvement initiatives.
• Authoring of SOPs, protocols, technical reports, regulatory documents.
• Complies with all applicable laws and Company policies regarding health, safety, innovation and environment.

QUALIFICATIONS AND EDUCATION

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• PhD in Life Sciences, bio-engineering, or related discipline with 5+ years of relevant industry experience.
• Experience with biological products is critical, experience specifically with cell therapy technologies is preferred.
• Demonstrated track record with cell process development supporting early and late-stage development of cell therapies.
• Deep technical understanding of cell production technology and cell process development

REQUIRED SKILLS, KNOWLEDGE, AND ABILITIES

• Strong experience in cell therapy process development using multivariate studies using Quality by Design principles.
• Experience with JMP software or equivalent.
• Demonstrated cell production technology development experience in a cell therapy setting.
• Must have strong initiative and drive to complete challenging tasks and learn new technologies.
• Ability to meet deadlines, adapt to rapid changes, and work in a fast-paced team environment.
• Demonstrated experience working effectively with both independently and with other interdisciplinary and cross-cultural team of scientists, engineers, quality and regulatory specialists, and business professionals.
• Intermediate proficiency of MS Office products.

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

In addition to base pay, employees may be eligible for benefits such as health insurance, health savings accounts, retirement savings plans, life and disability insurance, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.