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

Responsibilities

• 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

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
• 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
• Travel up to 15%

Benefits

• Medical
• Dental
• Vision
• Life Insurance
• 401k
• Paid Time Off