CBM

Full Time EE

Center for Breakthrough Medicines is on track to be the largest single-site cell and gene therapy contract development and manufacturing organization in the world. Our comprehensive service offering accelerates speed to market through supply chain disruption mitigation strategies, end-to-end program management expertise and unique platform technology with the ability to follow a molecule from idea to commercialization. CBM’s integrated approach provides high quality and consistent end-to-end manufacturing capability including: Process and Analytical Development; Plasmid DNA production; Viral Vector Production of Lentivirus; AAV and Adenovirus; Testing and Analytics; Autologous, Allogeneic and Gene-edited Cell Therapy Bioprocessing; and Cell banking. CBM’s horizontal and vertical integration provides one source throughout a product’s life cycle.

CBM’s mission is to accelerate the delivery and affordability of lifesaving and life-changing therapies from discovery to market by offering a complete solution for the development and commercialization of cell and gene therapies.

CBM is located just outside of Philadelphia in the Heart of Cellicon Valley on The Discovery Labs campus set on 300 acres with 2.4 million square feet of life sciences lab and manufacturing space, allowing clients to scale their development and manufacturing needs without ever having to change sites, while providing employees a true community campus experience focused exclusively on life sciences.

Summary

The biosafety officer will be responsible for the development, implementation and management of the biosafety program for the Center for Breakthrough Medicines. The biosafety officer will analyze all biological components associated with the facility and operations, as well as perform risk assessments of new client processes with regards to equipment, biological agents, protocols, test methods and processing applications.

Responsibilities

• Responsible for development and implementation of the Biosafety program.
• Management of the Biosafety program in partnership with EHS, Operations, Quality Assurance and Site Leadership.
• Provides biosafety guidance to a cross-functional team for customer projects in laboratory services, process development and/or manufacturing in a R&D and GMP environment
• Develop a site training program and implement regular training at the site.
• Develop procedures and a surveillance program to mitigate biological risks and owns the vaccination program for new and current employees
• Perform risk assessments of new client processes as part of the New Product Introduction process with regards to equipment, biological agents, protocols, and process applications.
• Prepare, update, and draft policies, guidelines, and procedures for biological hazards, processes, and emergency response.
• Performs laboratory audits and inspections, select agent inventories, and other duties as assigned.
• Supports the process of importing/exporting biological agents, permit applications, shipment of biological agents and equipment.
• Collaborates with and supports general EHS at all CBM locations, inclusive of liaison to Safety Committees and chair of Biosafety Committee.
• Collaborates with other CBM locations to further Biosafety within the organization.
• Interfaces with clients and regulatory agencies for audits and inspections.
• Be able to understand and articulate the business drivers aligned with the Biosafety strategy.
• Develops, implements and delivers Biosafety training to all personnel (CBM, Client, Contractor, etc)
• Develops, monitors, and ensures that EHS / Biosafety Key Performance Indicators (KPIs) are being fulfilled
• Ensures timely completion and compliance with SOPs and cGMP compliance and all other relevant company training requirements

Qualifications

• Previous experience implementing policies and procedures that mitigate biological risks, including the leading of culture change required to embrace those policy and procedure changes highly desired.
• Experience evaluating, providing advice and implementing solutions due to complexities of Biological safety, training and industrial hygiene issues strongly preferred
• Must be proficient in word processing and document preparation.
• Ability to work some long hours, work off shifts and off hours, potentially work a Saturday.
• Knowledge of: OHSA, EPA, CDC, NRC, DOT, WHO, IATA regulations as they apply to this position.
• Experience in a cGMP environment preferred.
• Excellent leadership, written and verbal communication skills and ability to influence others
• Excellent critical thinking and problem-solving skills
• Detailed and results orientated
• Excellent negotiation and facilitation skills, with strong communication skills
• Able to professionally handle multiple and sometimes competing priorities
• Strong aptitude for technical comprehension enabling rapid learning in a highly regulated environment
• Proficiency in Microsoft Office programs including Word, Excel and MS Project
• Ensures accuracy and relevance of assigned training curriculum
• Drives timely completion of training for employees to meet regulatory requirements
• Training, coaching, mentorship, and development of employees with regards to Biosafety

Education & Experience

• Masters in microbiology, biology or equivalent bioscience discipline.
• 5-7 years' experience in an applied setting preferably involving the coordination and management of a biosafety program.
• CBSP, RBP certification preferred

Competencies

• Previous experience implementing policies and procedures that mitigate biological risks, including the leading of culture change required to embrace those policy and procedure changes highly desired.
• Experience evaluating, providing advice and implementing solutions due to complexities of Biological safety, training and industrial hygiene issues strongly preferred
• Must be proficient in word processing and document preparation.
• Ability to work some long hours, work off shifts and off hours, potentially work a Saturday.
• Knowledge of: OHSA, EPA, CDC, NRC, DOT, WHO, IATA regulations as they apply to this position.
• Experience in a cGMP environment preferred.
• Excellent leadership, written and verbal communication skills and ability to influence others
• Excellent critical thinking and problem-solving skills
• Detailed and results orientated
• Excellent negotiation and facilitation skills, with strong communication skills
• Able to professionally handle multiple and sometimes competing priorities
• Strong aptitude for technical comprehension enabling rapid learning in a highly regulated environment
• Proficiency in Microsoft Office programs including Word, Excel and MS Project
• Ensures accuracy and relevance of assigned training curriculum
• Drives timely completion of training for employees to meet regulatory requirements
• Training, coaching, mentorship, and development of employees with regards to Biosafety