Sr. Manager, R&D- Upstream - Warminster, PA

Fujifilm•Warminster, PA

4d•$143,540 - $165,000•Onsite

About The Position

Position Overview Position Description We are hiring a Sr. R&D Manager - Upstream. The Sr. R&D Manager - Upstream will manage RUO to GMP conversion for Molecular Biology and Expression Testing, Cell Culture, and Bioassay Groups to develop, optimize, and execute cell culture activities and bioassays for all protein products. They will standardize and validate assays under GMP requirements, manage multiple projects and establish cross-functional cross-department workflows, document data under GMP guidelines, prepare presentations for meetings and reports for senior management as needed. They will also lead, manage and deliver high profile, publication quality research and development work tied to business needs and support colleagues within the organization to do the same by fostering learning, respect, and collaboration. Company Overview At FUJIFILM Biosciences, we turn curiosity into breakthroughs that advance the field of life sciences. By offering a comprehensive portfolio of products and services in cell culture media, discovery research reagents, recombinant growth factors and proteins, fine chemicals, and critical assay materials, we partner with the brightest minds in biotech and pharma to tackle the world’s biggest health challenges. Imagine being part of a team that enables life-changing discoveries like new vaccines, therapies, and advancements in regenerative medicine. Our culture fosters curiosity, collaboration, and innovation, and we pride ourselves on delivering unparalleled quality and service to our partners. If you’re ready to make an impact, your future belongs with us at FUJIFILM Biosciences. Our headquarters in Santa Ana, California, is surrounded by world-class schools, lush parks, and scenic beaches like Laguna and Huntington, making it an ideal place to live, work, and explore. With additional campuses across the US, Europe, China, and Japan, we offer opportunities to make a difference worldwide. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers Job Description

Requirements

Masters or PhD in a Biological/Chemical Science plus relevant work experience
Minimum 5 years of relevant working experience
Exposure to GMP environment
Team leadership and staff development
Broad experience with analytical protein characterization methods including bioassay, cell culture growth and expression and various molecular biology techniques.
Working in a cGMP environment
Ability to work as a team player with a positive attitude
Ability to multi-task, attentive to details, and working within a compliance-driven department
Ability to speak, write and read English fluently
Travel up to 15%.

Responsibilities

Lead key projects with R&D to support business goals
Planning for production needs of quality controlled cell banks of prokaryotic and eukaryotic expression systems for use in manufacturing
Plan experiments, including proper controls and sampling strategies
Extensive hands-on experience with cell-based, biomarkers and pharmacodynamic assays including cytokine analysis experience
Experience in qtPCR, ELISA, Western, cell culture including primary cell isolation, additional gene or protein expression methods and statistical data analysis.
Development of new mammalian clones and characterization for establishment of clonal products and cell banking using industry best practices
Maintain manufacturing records
Present data to the department and project teams
Write standard operating procedures, study reports, relevant sections of regulatory filings, and scientific presentations
Assess the scope of research projects and ensure they are on time and within budget
Research, design and evaluate materials, assemblies, process, and equipment
Suggest training tools to enhance employee performance and skill development
Monitor team metrics and objectives ensuring meeting of goals
Oversee in documenting all phases of research and development
High level of expertise to troubleshooting complex technical problems and finding appropriate solutions.
Excellent organizational and documentation skills with prior experience writing bioassay development reports in a GLP-like environment
Ability to work independently, with minimal supervision, highly self-motivated and detail-oriented individual, with proven ability to work in a dynamic and fast paced environment in a small startup company.