Iovance is seeking a Senior Director, Manufacturing Operations who responsible for developing strategy, setting direction, and continuously improving the manufacturing operations and process for the new Iovance manufacturing site at 300 Rouse Boulevard, Philadelphia, PA. This individual will be directly responsible for the operational teams that support clinical and commercial manufacturing. This individual will provide guidance and oversite to the process and production, ensuring material is made in a safe and compliant manner and meeting company targets. The Senior Director will also be responsible for the development of strategy to accommodate Iovance’s needs within the operations space as a growing organization.
- Develop and grow the organizational infrastructure, support services, and operating strategy for manufacturing in a new commercial suite value stream.
- Oversee the continued operation and improvement of a clinical suite value stream intended for multi-product use.
- Ensure site resources are adequate to complete operations and fully optimized to support both operating suites in a dynamic supply environment.
- Develop and provide monthly manufacturing metrics and “Health of the Operations”
- Serve as a key participant in the manufacturing site leadership team to influence cross functional leadership in support of strategic operations initiatives.
- Identify and implement strategic continuous improvement opportunities for process and production related items. Expertise level in visual management, KPIs, huddle boards etc.
- Ensure the effective application of internal control systems and procedures applicable to each functional area of responsibility by providing management direction to operations personnel.
- Develop and undertake an effective communication strategy for a rapidly growing team in a dynamic environment.
- Provide leadership to ensure the organization attracts, trains, develops and retains the best people and fosters an environment which motivates a diverse team to fully use its capabilities in achieving the desired business results
- Minimum B.S degree in biochemistry, chemical engineering, bioengineering, or related technical field, or equivalent industry experience.
- At least 20 years of relevant operations experience for clinical and commercial production in the life sciences industry. Cell and gene therapy experience is preferred.
- A minimum of 10 years in a supervisory role, with increasing responsibility. Ability to manage and influence large teams within the manufacturing environment (potentially 50+ employees)
- Solid knowledge of FDA regulations and GMP systems.
- Solid knowledge of human error reduction strategies, right-first time execution, and just culture.
- Demonstrated technical knowledge aseptic processing in cleanroom environments a must.
- Excellent oral and written communication skills. Strong technical writing ability required.
- Ability to motivate and mentor peers, staff, foster a culture of continuous improvement and operational excellence.
- Self-motivated and willing to accept temporary responsibilities outside of initial job description.
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
- Must be comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
- Project management skill set with experience in strategic/tactical planning, team building and meeting budgets.