Director, Commercial Manufacturing Validation

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner.

For more information on SMPA, visit our website  or follow us on Linked In.

We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Director, Commercial Manufacturing Validation
. This role functions within SMPA's Global Technology and Quality organization. In this capacity, the successful candidate will help ensure the globally compliant validation program for SMPA's development and commercial portfolio of products, working with small molecule solid dosage forms. This position ensures that SMPA operates under a Lifecycle Validation model, and that Validation Master Plans are implemented and updated for all development and commercial GMP programs.

The individual must have the ability to work independently and as an effective and engaged team member in a fast-paced environment. Strong initiative and follow-through are essential for this job. The ability to maintain confidentiality and to operate in a role with the highest ethical standards and professionalism are required.

• Accountable for contributing to validation strategies, programs, and continuous improvement initiatives.

• Contribute to and maintain the policies and procedures for a compliant Lifecycle Validation model (Stage 1,2, and
  3) that supports phase appropriate development programs, NDA/BLA enabling validation programs and ongoing commercial manufacturing activities.

• Establish and maintain Validation Master Plans for all SMPA programs/projects, ensuring they are managed and conducted in a consistent manner.

• Lead/support technical transfers activities from a validation and compliance perspective.

• Demonstrate effective leadership on a global level in cross functional teams with internal resources and external CMOs to adopt the required validation policies and procedures.

• Partner on a global level in cross functional teams with internal resources and external CMOs to drive process characterization, variability assessments and statistical evaluation of multiple complex parameters and validation for all programs.

• Accountable for ensuring compliant validation of the following activities - equipment and utilities qualification/validation, process development, process validation, continued process verification, equipment cleaning validation and transportation qualification/validation.

• Plan, Design and execute major NDA/MAA enabling projects through sound DOE, early risk assessments and thorough itemization of applicable deliverables. Have full awareness of the potential consequences (defects and failure modes) of design parameters to establish robust and reproducible processes.

• Responsible for monitoring process and product performance/process history/ technical assessments and ownership of change controls and process deviations both internally and at CMO sites.

• Lead author for applicable sections in regulatory submissions.

• Participate in all validation activities pertaining to commercial products (regulatory starting materials, drug substances, and drug products).

• As needed, work as a member of SMPA's cross-functional product development teams.

• Perform other duties as assigned.

• Good understanding of the CMO landscape, knowledge of CMO capabilities, and limitations.

• Demonstrates in-depth knowledge of Good Manufacturing Practices (GMPs).

• Demonstrates in-depth knowledge of manufacturing principles, concepts, industry practices, and standards.

• Must have strong analytical, problem solving, and statistical analysis capabilities.

• Ability to work effectively in a global cross-functional team environment.

• Ability to work across locations and time zones.

• Strong interpersonal skills with the ability to…