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

Fujifilm•Warminster, PA

9d•Onsite

About The Position

We are hiring a Sr. R&D Manager - Upstream. The Sr. R&D Manager - Upstream will lead upstream process development including Cloning, Expression Testing and Cell Culture Development (bacterial and mammalian) for recombinant growth factors. Lead Research Use Only to GMP conversion, manage multiple projects and establish cross-functional and cross-department workflows, document data under GMP guidelines, prepare presentations for meetings and reports for senior management as needed. 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.

Requirements

Masters or PhD in a Biological/Chemical Science plus relevant work experience
Minimum 8 years of relevant working experience
Exposure to GMP environment
People leadership and staff development
Experience in fermentation process development
Hands-on experience with operating 5L to 100L fermenter (bacterial).
Hands-on experience with bioreactor (mammalian) operations.
Experience with process scale-up from R&D to production scale.
Experience in mammalian cell culture including primary cell isolation, cell line development, and statistical data analysis.
Experience in making genetic constructs for bacterial and mammalian protein expression.
Working in a cGMP environment
Good management, communication both oral and written and organizational skills.
Excellent organizational and documentation skills.
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.
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

Responsibilities

Lead upstream process development (Bacterial and Mammalian) and manufacturing to support business goals
Troubleshoot technical challenges during R&D and manufacturing
Lead production of cell banks of Bacterial and Mammalian expression systems for use in manufacturing
Lead 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