Senior Manager, Combination Product Development

Job Description This Individual Contributor position reports to the Director of Device Development and Technology. The role requires deep knowledge of combination products and drug delivery devices, with primary expertise in engineering, device quality systems (CFR 820, ISO 13485), human factors engineering principles, risk management for medical devices (ISO 14971), and strong technical writing and presentation skills. The candidate should have 5‑8 years of applicable experience in the pharmaceutical, biotechnology, or medical device industries. The primary responsibilities include management of design history files, support authoring of technical dossiers for combination product and device projects, facilitation of risk assessments, coordination of human factors usability studies, creation and management of product and component specifications, design control documents, engineering protocols, technical reports, and frequent presentations to project teams and senior management. The position often requires management of outside resources and unassigned leadership of project teams in a matrix organization. Technical writing experience is required. Travel may be required up to 15‑20% domestic and international. Job Responsibilities Support the vision for the Device Development function. Develop and support strategic activities aligned with OPDC objectives and business development programs. Work with Device Development, Technology, Packaging, Supply Chain, Clinical Supplies Operations, Quality Control, Regulatory, and Quality Management to support product and process improvements. Support appropriate filing strategies working with OPCJ, OPDC, MDD, and OAPI departments for registration of new and life‑cycle management products. Evaluate new and innovative delivery device technologies for new and life‑cycle management projects. Ensure efficient transfer of products and ongoing support of all products to CMOs from a device perspective. Develop and maintain departmental knowledge of state‑of‑the‑art devices for pharmaceutical products. Assure adherence to worldwide regulatory rules and guidance concerning devices and develop 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 tools; manage cross‑functional teams and 3rd‑party resources. Execute Human Factors Engineering and Usability activities. Qualifications and Requirements 5‑8 years’ experience in pharmaceuticals, medical devices, biotechnology, or related industries. In‑depth understanding of device verification, functional testing, process validation/verification, quality assurance, and regulatory requirements. Ability to work strategically and independently with internal and external groups. Demonstrated leadership skills, especially in managing high‑visibility project teams. Knowledge of parenteral delivery devices (syringes, self‑injectors, auto‑injectors). Self‑starter: ability to solicit and obtain time‑sensitive information from stakeholders. Effective communicator across all levels of the organization. Ability to deliver high‑level and detailed status reports on programs, projects, and portfolio information. Utilizes business and project management software (MSProject, MSOffice). Experience with usability testing, user studies, and 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.). Master’s or advanced degree preferred. Competencies Accountability for Results : Stay focused on key strategic objectives and lead change. Strategic Thinking & Problem Solving : Make decisions with long‑term impact. Patient & Customer Centricity : Focus on customer needs. Impactful Communication : Communicate clearly and influence at all levels. Respectful Collaboration : Value diverse perspectives and partnerships. Empowered Development : Engage in professional growth. 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; generous 401(k) match; flexible time off; paid holidays and leave programs. Minimum $150,034.00 – Maximum $224,250.00 with an incentive opportunity. The pay range represents the typical starting pay for individuals hired in the role in the United States. Actual pay may vary based on experience and skill. Equal Opportunity Statement Otsuka is an equal opportunity employer. All qualified applicants are considered for employment without regard to race, color, sex, gender identity or 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 reasonable accommodation. Contact Attribution: View email address on click.appcast.io‑us.com. #J-18808-Ljbffr Otsuka America Pharmaceutical Inc.