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 for API and excipients, bulk formulation, device components, filling and assembly, and secondary packaging

• Develop and implement operational objectives, policies, and procedures for technical product ownership activities

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

• Create and execute technical enhancement plans aimed at improving robustness, minimizing variability and defects, increasing yield, reinforcing supply continuity, and reducing costs while ensuring quality and compliance

• Sustain the product and process knowledge repository, which includes 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 encompasses data collection, performance trending, alert and action-limit review, and action-plan management

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

• Oversee changes in manufacturing and supplier operations and assist in post-approval modifications, qualifications, stability assessments, batch-record updates, and impact evaluations

• Support the maintenance and reliability of Satsuma-owned manufacturing equipment, including equipment modifications, reliability enhancements, maintenance planning, critical spare strategies, and assessments of automation or software changes

• Facilitate regulatory inspections, partner audits, and internal preparation for inspections

• Draft and review technical documentation for post-approval submissions, regulatory obligations, health authority inquiries, audits, and inspections

• Collaborate with Quality, Regulatory Affairs, Supply Chain, Commercial teams, and external partners to prioritize technical tasks, support supply decisions, and implement modifications

• Lead significant technical improvement initiatives that span multiple organizational areas

• Proactively take on additional responsibilities, initiatives, and special projects as business requirements change

• 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, including support for commercial or late-stage products

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

• Practical knowledge 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 experience in leading investigations and improvement projects, statistical analysis, process-capability assessments, and root-cause analysis

• Familiarity with relevant FDA and ICH guidelines and requirements

• Excellent project-management, collaboration, and communication abilities

• 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 locations as needed, anticipated at up to 25%

• Demonstrated ability to advise teams on moderately complex issues and contribute to accountability for outcomes affecting the business segment

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

• Must meet all applicable work authorization and employment eligibility criteria

🏝️ 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