Manufacturing Science and Technology Manager/Senior Manager

Job Overview

We are inviting applications for the role of Manager/Senior Manager of Manufacturing Science and Technology (MS&T), located in Germantown, MD. This represents a remarkable opportunity to engage in the development and delivery of pioneering gene and cell therapies. As a vital member of our innovative team, you will assume a key position in providing technical support for Gene Therapy cGMP manufacturing, contributing to the transition of advanced treatments from late clinical phases to commercial launch.

Key Responsibilities

• Deliver comprehensive technical support for gene therapy product manufacturing, encompassing both drug substance and drug product, at our facilities and with Contract Manufacturing Organizations (CMOs).
• Collaborate across multiple departments, including process development, manufacturing, quality assurance, quality control, supply chain, and facilities, to ensure effective process transfers and implementations.
• Provide hands-on technical oversight during product manufacturing campaigns, assisting in troubleshooting processes and equipment issues, particularly at CMOs.
• Collect, analyze, and trend process data; perform capability assessments and identify opportunities for process enhancement.
• Author and review various technical documents such as process transfer summaries, risk assessments, and specifications, in alignment with tech transfer and regulatory compliance.
• Offer technical expertise to investigate and address production challenges, driving corrective actions and improvements.
• Lead and support initiatives aimed at process enhancement, including the integration of new technologies into the manufacturing framework.
• Serve as a subject matter expert on technical documentation related to project plans, process understanding, and regulatory submissions.
• Create and uphold a center of excellence focused on manufacturing data management and operational advancements.
  
  

Required Skills

• Proficient in technical writing and the ability to convey complex information with clarity.
• Strong analytical and critical thinking skills, coupled with a quantitative mindset for problem-solving.
• Hands-on experience with process development, scale-up studies, and operations in upstream cell culture and downstream unit operations.
• Familiarity with software tools for data management and statistical analysis, including Excel and MiniTab.
• Expertise in upstream and downstream vaccine/vector manufacturing operations is advantageous.
  
  

Qualifications

• Educational Background: B.Sc or M.Sc in Chemical Engineering, Bioengineering, Biotechnology, or a related discipline.
• Experience: A minimum of 4 years in overseeing process changes, technology transfer, and manufacturing support in cGMP biopharmaceutical settings.
• Familiarity with SAS/JMP statistical software and BioSolve is a plus.
  
  

Career Growth Opportunities

This position offers substantial avenues for professional development, including active participation in process improvement projects and the incorporation of emerging technologies, fostering a diverse and fulfilling career trajectory.

Company Culture And Values

We are dedicated to fostering a collaborative and high-performance environment that prioritizes teamwork and maintains rigorous quality standards within a technical framework. Our team members are encouraged to be proactive problem solvers and contribute to a culture of excellence.

Networking and Professional Opportunities

Joining our team presents ample opportunities for networking and professional collaboration, enhancing your skills while connecting with other industry experts.

Employment Type: Full-Time