Associate Director, Contract Manufacturing

Associate Director, Commercial Drug Product Manufacturing And Packaging

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.

The associate director, commercial drug product manufacturing and packaging is responsible for overseeing crucial manufacturing production and ensures uninterrupted supply of SMPA's commercial oral solid dosage (OSD) portfolio through successful execution of production campaigns within our global network of external contract development & manufacturing organizations (CDMOs). This role will serve as a leader and work with external manufacturing sites to ensure quality and compliance is met, provide technical oversight; collaborates with internal stakeholders and alliance partners to bring commercial products to desired markets; leads technology transfer and ensures commercial preparedness for manufacturing at CMOs.

The individual must have the ability to work independently, be an effective and engaged technical and strategic leader in a fast-paced environment. This role requires excellent technical expertise, strong interpersonal skills, and outstanding communication skills to manufacture and deliver important medicines to patients.

Job duties and responsibilities :

• Oversee and coordinate the overall evaluation and selection of external contract development & manufacturing organizations (CDMOs) for commercial needs.
• Serves as a point of contact for contract development & manufacturing organizations (CDMOs), and act as technical lead.
• Actively manages CDMOs in assigned projects to coordinate technology transfer and development efforts per project milestones, timelines, and deliverables for projects.
• Reviews and coordinates quality-related documents pertaining to production with CDMO's (complaints, deviations, change controls, OOS, etc.)
• Assists in coordinating release and stability tests for drug product manufacturing and packaging.
• Responsible for implementation and maintenance of serialization systems to ensure compliance with regulatory requirements and enhance traceability within the pharmaceutical manufacturing process.
• Monitors and verifies implementation of SMPA's controlled documents at CDMOs partner sites.
• Assist in review and revision of departmental SOPs in order to streamline and improve current practices.
• Manages CDMOs on a daily basis, responsible for all interactions with CMO's on the assigned projects.
• Works with line manager and partner functions to develop processes / systems to effectively manage vendor selection and performance assessments.
• Participates in solving issues of high complexity.
• Communicates issues to line manager and project team in a timely manner.
• Develops specific manufacturing recommendations for coordination of production schedules, environmental concerns, and safety issues.
• Coordinates production flow from process development to manufacturing.
• Responsible for driving continuous improvement in all operation processes.
• Assist in continuous process verification (CPV) of all products.
• Perform other duties as assigned.

Key core competencies :

Education and experience :

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.