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

FUJIFILM Holdings America Corporation; Warminster Township (Bucks County); On-site; USD 143,540 - 165,000; Full time

Benefits offered by this job

Medical, Dental, Vision

401k

Paid Time Off

Job summary

FUJIFILM Holdings America Corporation is seeking a Sr. R&D Manager - Upstream to oversee the RUO to GMP conversion for various protein products. The role requires at least 5 years of relevant experience in a GMP environment, a Master's or PhD in a biological or chemical science, and a proven ability to manage projects while fostering collaboration in a fast-paced setting. The position offers a competitive salary and benefits including medical and retirement plans.

Qualifications

• 5+ years of relevant working experience with a Master's or PhD.
• Experience in a GMP environment with bioassay and cell culture methods.
• Strong ability to work independently with excellent organizational skills.

Responsibilities

• Lead key R&D projects supporting business goals.
• Plan and execute cell culture activities and bioassays.
• Write standard operating procedures and study reports.

Skills

Team leadership

Analytical protein characterization

Cell culture techniques

Molecular biology techniques

Communication skills

Education

Masters or PhD in Biological/Chemical Science

Tools

qtPCR

ELISA

Western blot

Job description

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.

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 troubleshoot complex technical problems and find 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.
• 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

EEO Information

Fujifilm is committedto 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.