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

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

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.

Required Skills/Education:

• 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.
• Experience in fermentation/bioreactor operations.
• 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
• Good oral and written communication skills
• Travel up to 15%.

Salary and Benefits:

• The base salary range for this position is $143,540- $165,000. Compensation for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience, location, etc.).
• Medical, Dental, Vision
• Life Insurance
• 401k
• Paid Time Off

*#LI-onsite

EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ([email protected]).