Director of Manufacturing
Reports to Vice-President of Manufacturing
The Director of Manufacturing is responsible for oversight and planning of drug product manufacturing. This role serves as the subject matter expert for all aspects of drug manufacturing including upstream bioreactor production and downstream purification operations. As a single point of accountability for all aspects of site operations, the Director of Manufacturing will have responsibilities for leading production of clinical oncolytic virotherapies as well as supporting the product development of pipeline oncolytic virotherapies. This role will focus on technology transfers, process development and optimization and routine clinical cGMP manufacturing.
Fosters teamwork, personal responsibility, integrity, innovation, trust and communication
- Exhibits an understanding of the roles and responsibilities of team members and recognizes individuals for their contributions
- Contributes to the enhancement of the groups effectiveness by exchanging information, collaborating with other team member and providing constructive feedback
- Accepts feedback and uses it to improve individual and team performance
- Effectively manages emotions, including anger and frustration
- Adjusts to change in a positive and supportive manner
- Completes assignments on time and contributes extra effort to meet organizational needs
Adheres to high standards of personal and professional conduct
- Conducts discussion of confidential information in an appropriate setting to avoid unintentional disclosure
- Conducts work related activities in accordance with the Vyriad Compliance Program and Code of Conduct
- Complies with policies, procedures, guidelines and applicable laws and regulations when conducting daily activities
- Contributes ideas and suggestions and participates in activities that improve systems, processes and services
- Treats others with dignity, mutual respect and contributes to a work place that is free from harassment
- Supports an inclusive work environment by actively discouraging negative cultural, racial, religious, age, disability, socioeconomic, educational, sexual orientation, veteran status, marital status or gender stereotypes
Develops and builds the cGMP-manufacturing and process development functions and capability.
- Leads the development of CMC strategies, capabilities for oncolytic virotherapies and execution of Vyriad’s oncolytic virotherapies programs:
- Direction of technical activities for upstream, downstream and formulation development activities to ensure scalable and commercially viable processes are developed.
- Responsible for all aspects of process scale up, technology transfer and GMP manufacturing.
- Ensure process development group best practices that are aligned with current GMPs.
- Builds, maintains and motivates a multi technology operations team capable of achieving all productivity targets and output requirements to service customers with product on time.
- Cross functional collaboration with Quality Assurance and Quality Control areas to plan and implement the execution of cGMP activities in manufacturing operations for both development processes and commercial operations.
- Develops and manages the budget requirements for each fiscal year. Organizes the purchase of appropriate capital items as required for projects.
- Develops and leads a culture of learning, respect, and employee growth. Establishes the department’s strategic vision and mentor the manufacturing ops team towards goal achievement.
- Responsible for operating all activities in a manner that complies with appropriate safety, regulatory and legal requirements.
- Provides technical leadership and direction to staff internal for process optimization, transfer, and troubleshooting.
- Supports manufacturing campaigns with Person-in-Plant activities, deviation investigation and closure, and technical batch record review for batch release.
- Manages CMO/CRO relationships, to include planning, coordination and technical oversight of drug product activities. Serve as primary contact to support drug product manufacture.
- Designs and plans efforts to improve process efficiency and yields and reduce cost of goods.
- Presents technical information to diverse audiences in a clear and consistent manner.
- Provides vision concerning production methods, equipment, process validation requirements (IQ, OQ, PQ), CMC testing and supply chain management tools
- Directs manufacturing staff to ensure the timely delivery and Right-First-Time execution of manufacturing operations for product manufacturing and development projects.
- Establishes strategic direction for manufacturing resources and activities, and set objectives to maximize new technologies and capabilities.
- Maintains the operational activities at the highest level of cGMP compliance.
- Ensures that operations are compliant with policies and procedures at all times.
- Ensures continued operational efficiencies are realized with reliable schedule adherence, and on time delivery of product, while maintaining the ability to react to changing customer requirements.
- Responsible for participating and representing all manufacturing operations in client audits as appropriate.
- Manages Contract Manufacturing Organization relations, to include planning, coordination and technical oversight of manufacturing activities.
- Participates in the preparation of CMC sections of regulatory filings (IND, NDA’s, annual updates).
- Develops quality and business metrics for assessing productivity/profitability of manufacturing.
- Performs annual planning for manufacturing initiatives.
- Ensures staff training programs are developed and implemented, and effectively provide the tools and information for staff to carry out their assigned duties.
- Assists in the collection, analysis and interpretation of monitoring data for regulatory issues (using statistical tools and graphs). Determines if, or recommends when, process improvements are needed.
Demonstrates effective leadership skills
- Promotes adaptation and flexibility in a rapidly changing environment. Acts as a change leader through team building and influence. Willingness to make difficult or unpopular decisions when warranted.
- Collaborates with colleagues to identify efficient solutions which meet the needs of a variety of stakeholders.
- Effectively evaluates risk, including issues which may involve ambiguity and have significant impact on business and/or personnel decisions. Utilizes good analytical skills, intuition, and other expert resources as appropriate to develop response/plans.
- Recognizes the need for self-development and growth needs to improve personal and professional skills.
- Ensures disciplinary policies are applied and followed consistently.
Leads by creating a positive environment of open communication and staff development
- Provides continuous and timely performance feedback to direct reports, including coaching on performance management and professional advancement.
- Provides employee recognitions for accomplishments in a thoughtful and timely manner.
- Delegates work assignments to staff as appropriate, considering employee strengths and expertise to address associated tasks.
- Mentors individuals, based on individual needs, to meet current job expectations and career goals.
Doctoral degree in an Engineering or Scientific discipline with at least 5 years of experience in virotherapy process development and GMP manufacturing with 5 years of this being in a managerial position, or
Master’s degree in an Engineering or Scientific discipline with more than 10 years of experience in GMP manufacturing with 5 years of this being in a managerial position.
Experience and Skill Requirements
Biotech experience is required (cell and gene therapy, virology or biologics preferred). Understanding of upstream bioreactor production and downstream purification operations such as centrifugation, ultra-filtration and chromatography from pilot to GMP scale is required. Previous experience with FDA current Good Manufacturing Practices, European Union regulations, and/or ISO certification for product manufacturing is required. Additional experience with other international regulations is highly desirable. Must have experience with IND filings.
Excellent communication, interpersonal skills, and people management skills through all levels of the organization. Responsible for building both a high performing team and high performing systems in order to drive and sustain business growth. Should be very detail-oriented and have the ability to work independently and productively with minimal direction, and routinely exercise initiative and sound judgment. The ability to exercise good judgment in ambiguous situations while under pressure and tight deadlines, and strong coping skills are required. Must be flexible in adapting to a variety of responsibilities, work assignments, and priorities. Must be self-motivated and able to independently schedule workday activities with minimal direction.