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 LinkedIn.

Job Overview

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. 

Job Duties and Responsibilities

• 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. 

Key Core Competencies

• 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 influence others, internally and externally, in a positive and effective manner. 

• Exceptional organizational skills with the ability to manage multiple complex projects/tasks at the same time, and to effectively prioritize deliverables.

• Excellent written and oral communication skills. 

• Highly proficient using Microsoft Word, Excel, PowerPoint, Project, and SharePoint; or similar applications and systems. 

• A commitment to collaborative leadership, management, teamwork, delegation, and the maintenance of a professional culture based on trust and mutual respect. 

Education and Experience

Minimum 10 – 15 years (w/o Masters) or 8 – 12 years (with Master's) of relevant experience in biotech or pharmaceutical industry

Validation experience with multiple therapeutic modalities (e.g. API, solid dosage, biologics, gene therapies, drug/device combination products) is required. 

Must be familiar with EMA and FDA validation requirements, including Lifecycle Model. 

Lean Six Sigma training/certification is preferred

The base salary range for this role is $173,200 to $216, Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state.  Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter.  Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.

Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.

Compliance: Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Mental/Physical Requirements: Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.

Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer

Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.