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

Reporting to the Vice President of Quality and Compliance, the Senior Director of QA Viral Vector Manufacturing Operations will be a key member of the Quality Assurance team and is responsible for ensuring that quality and compliance are integrated into long term strategies and day to day operations. This role is instrumental in establishing, improving, and maintaining quality systems at CBM and driving functional and cross-functional projects that embed continuous improvement principles across the company. The Senior Director directs the activities of compliance within Quality Assurance for Viral Vector Manufacturing. This includes the supervision and mentoring of staff, budgeting and resource analysis. In addition, the Senior Director will provide technical, quality, and regulatory guidance in support of Viral Vector Manufacturing operations. Lastly, the Sr. Director will be responsible for ensuring all operations relating to products or services meets the established standards and client requirements.

Responsibilities

• Responsible for leading the QA manufacturing operations and ensuring that compliance objectives are maintained in the context of overall organizational needs and objectives with oversight of QA Compliance, Document Control, and Training, and other functions assigned to QA across viral vector manufacturing.
• Lead CBM efforts to remain “inspection ready” and represents QA during regulatory inspections and client audits.
• Interpret industry regulations and guidance documents for the creation and implementation of quality standards, policies, and site procedures
• Provide direction for the review of compliance procedures, Standard Operating Procedures, master batch records, specifications, validation master plans, and validation protocols and all other GxP documentation.
• Direct the review and approval of GMP impact changes to processes, product specifications equipment and facilities, including oversight of the risk assessment/management process. Provides direction for the review of all physical plant and equipment layouts and specifications to ensure compliance with internal and regulatory requirements.
• Support the internal and external audit programs to ensure appropriate GMP raw material and service suppliers are selected and maintained and that critical internal GMP systems are operated in a compliant manner.
• Judgment and problem-solving - able to define decision criteria and determine the most appropriate course of action.
• Planning and organizational skills - able to establish objectives and schedule tasks and resources efficiently.
• Communication skills - strong written communication skills to provide concise and clear documentation.
• Partner with other business units or departments in support of continuous improvement initiatives.
• Provide Quality System based leadership to ensure that CBM’s systems support the CBM quality mission and ensures quality products are produced for contract manufacturing clients.
• Leads the QA function and evaluates opportunities for continuous improvements, e.g. manufacturing process improvements, improvement to quality programs, etc...
• Lead the effort of tracking and communicating quality improvement initiatives throughout the organization and promoting a working culture in the organization that is quality based.
• Communicates Quality System performance to Senior Management on a regular basis and leads efforts to remediate compliance performance as required.
• Manage product complaints, adverse events, and any market action requirements from a quality assurance point of view.
• Manage the compliance function to ensure deviations, including reports associated with environmental monitoring, water, and cleaning excursions are effectively managed and decisions taken support the overall quality objectives, exercising direct supervision of critical compliance issues, and leadership of critical investigations where necessary.
• Hire, manage and train staff. Plan and assign duties to meet departmental and organizational objectives. Provide guidance and direction to staff; including appropriate training and mentoring for junior staff and development of senior staff to provide appropriate and adequate backup for primary QA Director functions.
• Develop budgets and manages resources to meet departmental and organizational objectives.

Qualifications

• Bachelor's Level Degree or equivalent in a scientific discipline and a minimum of 12 years of relevant experience or equivalent in Biologics and/or Cell and Gene Therapies.
• A combination of experience and/or knowledge of and willingness to adapt to the cGMP environment of Cell and Gene Therapy producing clinical trial materials and market licensed product is required
• Demonstration of initiative and leadership through experience
• Relevant experience and technical knowledge in viral vector products preferred.
• Demonstrated ability to interact with senior management and regulatory officials
• Clear, concise, written, and verbal communication and presentation skills
• Ability to manage risk by maintaining and applying extensive working knowledge of applicable cGMP, FDA, and EMA regulations
• Demonstrates potential for technical proficiency, scientific creativity, productive collaboration with others, and independent thought
• Strong organizational skills, demonstrated ability to prioritize projects, and to meet deadlines with minimal supervision are required
• Ability to manage performance and motivate personnel to work effectively and efficiently
• Demonstrated problem-solving skills