Vice President of Manufacturing
Reports to Chief Executive Officer
The Vice President of Manufacturing is responsible for leading drug manufacturing and facility operations of the GMP manufacturing facility. This role leads a team for the production of clinical oncolytic virotherapies as well as supporting the product development of pipeline oncolytic virotherapies focusing on technology transfers, process development and optimization and routine clinical cGMP manufacturing. In addition, leading the facility systems management and serves as the subject matter expert on the policies, processes and procedures supporting the facility by developing a broad knowledge of the business and technology.
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
- 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
Position Specific Competencies – Performance Expectations
- 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.
- Manages the manufacturing operations for drug substance and drug product.
- Oversees manufacturing incidents and investigations, corrective and preventive actions (CAPA), process variances and deviations.
- Ensures completion of manufacturing change controls, CAPAs, and deviations.
- Ensures that facilities are inspection ready including staff compliance with cGMP and all related elements such as documentation (standard operating procedures [SOP] and validation protocols etc.), training, reports and records.
- Develops short- and long-term goals for the manufacturing efforts in support of regulatory submissions, clinical efforts, and program-driven milestones.
- Effectively recruits, retains, develops and leads a manufacturing team.
- Leads and directs filing activities for regulatory agencies including assisting quality assurance in representing the site during agency inspections and in the formulation of inspection responses.
- Communicates and escalates operational status regularly.
- Collaborates across functions to drive manufacturing excellence, share best practices and lessons learned.
- 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.
- 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.
Ph.D. in Biology, Medicine, Chemistry, Engineering or related field required
- Ten (10) years of relevant experience in GMP manufacturing.
- Five (5) years of management or supervisory experience.
- Ten (10) years of relevant experience virotherapy drug manufacturing in a cGMP facility operating in a cleanroom manufacturing or FDA compliant environment.
Five (5) years of experience in pharmaceutical industry, medical device or chemical manufacturing or related area.
Experience and Skill Requirements
Advanced knowledge of current Good Manufacturing Practice (cGMP) regulations, European cGMP regulations (Annex 1, 15, 16) and related international standards including ISO-14644.
Advanced knowledge of FDA guidance relevant to the manufacture of investigational new drugs for human use and aseptic processing and FDA Title 21 of the Code of Federal Regulations Part 11.
Excellent verbal and written communication skills, critical thinking / problem-solving skills, interpersonal skills, time management skills, organizational skills, project management skills and leadership and strategic planning skills.