Senior Manager, Technical Product Owner

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Assist in the technical lifecycle management of Atzumi™.

• Act as the technical owner and subject-matter expert in areas such as API and excipients, bulk formulation, device components, filling and assembly, and secondary packaging.

• Define operational objectives, policies, and procedures related to technical product ownership activities.

• Serve as the technical liaison with contract manufacturing organizations and suppliers.

• Create and implement technical improvement plans aimed at enhancing robustness, reducing variability and defects, improving yield, ensuring supply continuity, and lowering costs while upholding quality and compliance.

• Maintain the product and process knowledge base, covering critical material attributes, critical quality attributes, critical process parameters, process dependencies, technical risks, and the rationale behind manufacturing processes.

• Establish and oversee continued process verification, which includes data collection, performance trending, alert and action-limit reviews, and action-plan management.

• Offer technical guidance and support for deviations, batch failures, complaints, nonconformances, supplier defects, atypical trends, and recurring performance issues.

• Manage changes in manufacturing and suppliers, and support post-approval changes, qualifications, stability, batch-record updates, and impact assessments.

• Aid in the maintenance and reliability of Satsuma-owned manufacturing equipment, including equipment changes, reliability enhancements, maintenance and obsolescence planning, critical-spare strategies, and assessments of automation or software changes.

• Assist with regulatory inspections, partner audits, and internal inspection-readiness activities.

• Author and review technical documentation for post-approval submissions, regulatory commitments, health-authority inquiries, audits, and inspections.

• Collaborate with Quality, Regulatory Affairs, Supply Chain, Commercial, and external partners to prioritize technical tasks, support supply decisions, and facilitate changes.

• Lead larger technical improvement projects that span various organizational areas.

• Proactively take on additional responsibilities, initiatives, and special projects as the business landscape evolves.

• Report directly to the Senior Director of Operations.

⛳️ Requirements

• Bachelor’s degree in chemical, mechanical, biomedical, pharmaceutical, manufacturing, or a related engineering field; pharmaceutical sciences, chemistry, or another relevant technical discipline.

• Over 7 years of experience in pharmaceutical, biotechnology, medical device, combination-product, MSAT/MS&T, process engineering, product stewardship, or technical operations roles, with a focus on supporting commercial or late-stage products.

• Experience in supporting pharmaceutical or drug-device combination products across various unit operations and/or external manufacturing partners.

• Proficient understanding of process validation, continued process verification, process capability, product quality review, deviation and CAPA systems, change control, risk management, and post-approval lifecycle requirements.

• Preferred experience with combination-product design controls, component specifications and drawings, supplier manufacturing processes, device assembly, and device risk-management documentation.

• Proven track record in leading investigations and improvement projects, statistical analysis, process-capability assessments, and root-cause analyses.

• Familiarity with applicable FDA and ICH guidelines and requirements.

• Strong skills in project management, collaboration, and communication.

• Capable of coordinating with CMOs and suppliers, managing multiple priorities, and clearly communicating technical risks and recommendations.

• Preferred experience with dry-powder formulations, nasal or inhalation delivery systems, unit-dose devices, spray-drying, powder filling, automated device assembly, or secondary packaging.

• Willingness to travel to domestic and international manufacturing and supplier sites as needed, with an anticipated travel requirement of up to 25%.

• Demonstrated ability to advise teams on moderately complex matters and contribute to accountability for outcomes that affect the business segment.

• An equivalent combination of education, training, and relevant experience may be considered in place of stated qualifications.

• Must meet applicable work authorization and employment eligibility requirements.

🏝️ Benefits

• Health Insurance

• Dental & Vision Insurance

• Healthcare & Dependent Care FSA

• Employee Assistance Program (EAP)

• 401(k) Savings Plan

• Long-term Incentive Plan

• Life Insurance

• Accident & Disability Insurance

• Telemedicine

• Generous Paid Time Off

• Company Holidays

• Remote work arrangement

• Equal opportunity employment