Building expert teams to advance science.

About the Role

At Rose BioSolutions, our capabilities span foundational research with human immune cells and stem cells to the complete advanced therapy manufacturing continuum. We are an established operation with a world-class team of experts, and we apply our R.O.S.E standard to every program and relationship: Reliable, Outcome driven, Scalable, and Excellent!

The Biomanufacturing Manager is responsible for leading all manufacturing activities related to the start-up and GMP production of novel cellular products for new and existing clients in compliance with regulatory agencies and associated guidelines. The Manager will also schedule appropriate resources to meet production schedules and maintain a state of safety, compliance, and control within manufacturing.

ESSENTIAL DUTIES AND RESPONSIBILITIES:  

• Oversee all activities related to the start-up and production of new and existing client processes in accordance with Cognate quality and production timelines and agreements.

• Schedule and manage manufacturing staff ensuring adherence to production schedules; coordinate with relevant functions to ensure schedule adherence.

• Ensure a safe and compliant working environment by enforcing safety and quality policies and practices.

• Serve as manufacturing representative on cross-functional teams ensuring on-time completion of deliverables related to technology transfer, operations, production, and disposition.

• Advise and inform site and company leadership of issues with the potential to impact production timelines or Critical Quality Attributes of client products.

• Participate in Regulatory, Quality, and Customer inspections and audits as manufacturing systems and production process SME.

• Work closely with clients and internal functions to troubleshoot and solve issues related to client processes and production.

• Build, train, and develop highly skilled production teams capable of producing cell therapy products in accordance with regulatory guidelines and Cognate quality standards.

• Oversee the drafting, review, and approval of process specific and Internal Quality System documents.

• Foster a culture of continuous improvement; identify opportunities and lead implementation of improvement activities, as required.

• Performs other duties as assigned.

• Perform all other related duties as assigned.

QUALIFICATIONS:

• BS or MS in a scientific field.

• Minimum of 4 years of applicable experience.

• Minimum of 2 years demonstrated success in a supervisory role.

• Exhibits Exceptional leadership skills and deep knowledge of GMP

• Must be detail oriented and have excellent organizational skills.

• Must possess effective written and oral communication skills.

• Must display a high degree of professionalism and confidentiality.

• Must demonstrate initiative to remain apprised of relevant industry and regulatory trends.

Compensation Data:

The pay range for this position is $94,000-156,500 per year. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

Why Join Us?

Impact: Every process we design is a step toward a cure. You’ll be making a real impact on the health of people in your community and across the globe.

Expertise: Work alongside a world-class team of scientists and operational leaders in a "no-ego" environment.

Stability & Growth: We offer the security of an established operation with the career growth opportunities of a rapidly expanding organization.

Perks & Benefits

• Competitive base salary with performance-based bonus opportunities.

• Comprehensive health, dental, and vision insurance.

• 401(k) with company contribution.

• Generous PTO and professional development support.

Rose BioSolutions is an equal opportunity employer committed to a diverse and inclusive workforce.