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 Associate Director, Manufacturing Sciences & Technology (MSAT), will lead a team of staff focused on process sciences, manufacturing support, and continuous improvement involving viral vector production at the Rockville site. This role is responsible for ensuring the robustness, scalability, and compliance of viral vector processes from clinical to commercial production. The leader will work cross functionally across the site, network partners, and clients to drive operational excellence, implement data drive process improvements, and support the successful commercialization of products. This role will interface with clients periodically as needed as well as regulatory agencies.

This position requires deep technical expertise in upstream and downstream processing techniques, viral vector characterization, and regulatory expectations across a multitude of viral vector modalities.

Why Rose BioSolutions 

At Rose, you are not just another layer in a large organization—you are a key contributor in a nimble, high-impact team. We offer:

• Direct exposure to diverse and complex client projects across multiple modalities.

• A collaborative, low-bureaucracy environment where ideas are heard and acted upon.

• Opportunities to grow your technical expertise and take ownership of your work.

• Close interaction with leadership and clients, enabling real influence on project outcomes.

ESSENTIAL DUTIES AND RESPONSIBILITIES:  

Strategic Leadership & MS&T Management

• Define and execute the MS&T strategy for viral vector process robustness, scalability, and lifecycle management.

• Build and develop a high-performing MS&T team supporting upstream and downstream production processes.

• Drive innovation and technical risk assessments to support process robustness and next generation manufacturing technologies.

• Ensure aseptic practices and controls (training, media fills, CCI) are aligned with current industry guidance and regulation.

Process Sciences & Technical Support

• Support process characterization and scale-up efforts with technical guidance and expertise.

• Own and optimize established critical process parameters (CPPs) and critical quality attributes (CQAs) using Quality by Design (QbD) principles

• Support execution of runs in manufacturing by training plant personnel in performance of the process.

• Collaborate with Process Development to refine real-time monitoring, PAT, and in-process control strategies.

Manufacturing Support & Troubleshooting

• Team will serve as technical leaders for real-time issues resolution, guiding manufacturing teams in troubleshooting deviations and complex process challenges.

• Oversee investigations (RCA, CAPA) for process-related deviations, ensuring data driven problem-solving.

• Support tech transfer activities between development, manufacturing, and external partners.

• Guide team through preparation of manufacturing instructions (SOPs, BPRs, OJTs, etc.) with periodic review and updates as needed.

• Partner with Quality and Regulatory teams to ensure compliance with cGMP, FDA, EMA, and ICH guidelines and regulations.

• Continuous Improvement & Operational Excellence

• Establish a data-driven culture by leveraging digital tools for continued process verification (CPV), real-time analytics, and process modeling.

• Champion advanced manufacturing approaches, benchmarking in industry to implement best-in class and competitive processing technologies at the site.

• Regularly review process performance to suggest improvements for consistent performance and quality.

Continuous Improvement & Operational Excellence

• Establish a data-driven culture by leveraging digital tools for continued process verification (CPV), real-time analytics, and process modeling.

• Champion advanced manufacturing approaches, benchmarking in industry to implement best-in class and competitive processing technologies at the site.

• Regularly review process performance to suggest improvements for consistent performance and quality

QUALIFICATIONS:

• Bachelor’s degree in relevant Science or Engineering discipline with a minimum of 10 years of experience or MS degree with 8 years' experience or PhD with 6 years’ relevant technical experience.

• 6+ years in a Leadership role within the Biologic/Gene Therapy Manufacturing Space

• CDMO working experience, interfacing between sponsors and manufacturers will be preferred.

• Technical expertise in upstream, downstream, and fill finish processes.

• Expert knowledge on industry guidelines and regulatory guidelines for aseptic processing.

Compensation Data:

The pay rate for this role is $165k – $185k 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.