Senior Manager, Combination Product Development

Otsuka Pharmaceutical Co., Ltd.; United States; Remote; USD 150,000 - 224,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

401(k) match

Paid holidays and paid time off

Job summary

Otsuka Pharmaceutical Co., Ltd. seeks an experienced Device Development professional in the United States. The role focuses on combination products and drug-delivery devices, managing design history files and technical dossiers across platforms.

The candidate will coordinate risk assessments, human factors studies, and the creation of specifications, design controls, and technical reports. Travel up to 15–20% may be required.

Qualifications

• 5-8 years of experience in Pharmaceuticals, Medical Devices, Biotechnology, or related industries.
• Deep understanding of device verification, testing, validation, QA, and regulatory requirements for devices.

Responsibilities

• Manage design history files and support authoring of technical dossiers for combination product and device projects.
• Facilitate risk assessments and coordinate human factors usability studies.
• Create and manage product and component specifications, design controls, engineering protocols, and technical reports.
• Present findings to project teams and management; coordinate external resources in a matrix organization.
• Develop project plans and manage cross-functional teams including third-party resources; execute HF engineering & usability activities.

Skills

Device development

Quality systems (CFR 820/ISO 13485)

Human factors engineering

Risk management (ISO 14971)

Technical writing

Presentation skills

Project leadership

Education

Bachelor's degree in engineering

Masters degree preferred

Tools

MSProject

MSOffice

Job description

Job Description

This is an Individual Contributor position, reporting to the Director of DeviceDevelopment and Technology. This individual is knowledgeable in the field of combination products &drug delivery devices Primary expertise shouldbe demonstrated in engineering, device quality systems (CFR 820, ISO 13485), humanfactors engineering principals, risk management for medical devices (ISO 14971), etc. The successfulcandidate should demonstrate strong technical writing and presentation skills and be able to translatetechnical information to non-technical audiences. This position requires 5-8 years of applicable experience in the pharmaceutical, biotechnology or medical device industries.

The candidate will be responsible for the management of design history files and support authoring of technicaldossiers for combination product and device projects for new and existing platforms. Additional responsibilities include facilitation of risk assessments, coordination of human factors usability studies, creation andmanagement of product and component specifications, design control documents, engineering protocols, technical reports, and frequent presentations to project teams and management. This position will frequentlyrequire management of outside resources as well as assigned and/or unassigned leadership of project teams in a matrix organization. Technical Writing experience required.

The position may involve frequent domestic and international travel up to 15-20% or as required by the project.

Job Responsibilities:

• Support the vision for the Device Development function
• Support a vision with appropriate strategies that supports the OPDC objectives and alignswith the business and OPCJ/OPDC/MDD development programs
• Work with members of Device Development and Technology, and other functions including Packaging,Supply Chain, Clinical Supplies Operations, Quality Control, Regulatory and Quality Management tosupport strategies for product and process improvements.
• Develop and support the strategic activities of the department
• Support appropriate filing strategies working with OPCJ, OPDC, MDD and OAPIdepartments to support registration of all new products and life-cycle management products.
• Evaluate new and innovative delivery device technologies to support new and life-cycle management projects.
• Develop and perform the tactical activities
• Ensure efficient transfer of products and on-going product support all products to CMO's from deviceperspective.
• Develop and maintain departmental knowledge, experience, and expertise in state-of-the-art devices for pharmaceutical products.
• Assure adherence to latest worldwide regulatory rules and guidance concerning devices and work todevelop device risk mitigation.
• Create, maintain, and update device related documents required for regulatory filings and compliance
• Facilitate studies as required.
• Write protocols, reports, specifications, procedures, change control requests, technical assessments, etc.
• Program management of Device projects
• Develop project plans and corresponding project managements tools to support the execution of allprojects
• Manage cross functional teams (including 3rd party resources)
• Execute Human Factors Engineering & Usability activities

Qualifications/ Required

Knowledge/ Experience and Skills:

• 5-8 years' experience in Pharmaceuticals, Medical Devices, Biotechnology, or other related industries
• In-depth understanding of device verification including functional testing, process validation/verification, quality assurance, and regulatory requirements as they pertain to and devices.
• Ability to work strategically and independently with internal and external groups.
• Demonstrated leadership skills especially the management of high-visibility project teams
• Demonstrated knowledge of parenteral delivery devices (syringes, self/ or auto-injectors), etc.
• Self-Starter: ability to solicit & obtain time-sensitive information from various internal & external project stakeholders
• Effective communicator across all levels of the organization
• Able to deliver high level to detailed level status reports on programs, projects and portfolio information
• Utilizes experience, presentation and influencing skills to facilitate successful team discussions and outcomes
• Competency in use of business and project management computer software (such as MSProject and MSOffice).
• Experienced with usability testing / user studies / human factors
• Ability to operate effectively in a fast-moving dynamic environment

Educational Qualifications

• Bachelor’s degree in a related Engineering discipline (Mechanical, Electrical, Biomedical, etc.)
• Masters or advanced degree preferred.

Competencies
Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
Empowered Development - Play an active role in professional development as a business imperative.

Minimum $150,034.00 - Maximum $224,250.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.

Application Deadline

This will be posted for a minimum of 5 business days.

Company benefits: Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.

Disclaimer:

This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.

If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request.