Senior Manager, Technical Product Owner

Satsuma Pharmaceuticals, Inc.; United States; On-site; USD 150,000 - 180,000; Full time

Benefits offered by this job

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

Job summary

Satsuma Pharmaceuticals seeks a Technical Product Owner to manage the AtzumiTM manufacturing technical lifecycle, coordinating API/excipient and device components with CMOs and suppliers. You will drive process control, data-driven improvements, and post-approval activities to ensure supply reliability and quality.

Reporting to the Senior Director, Operations, you will influence multiple teams, address complex technical issues, and pursue cost optimization while maintaining regulatory compliance

Qualifications

• Requires conceptual thinking and in-depth knowledge of organizational objectives.
• Experience coordinating CMOs and suppliers, and communicating technical risks.
• Familiarity with FDA/ICH guidelines and post‑approval lifecycle requirements.

Responsibilities

• Serve as the technical owner and subject-matter expert for AtzumiTM across APIs, excipients, and device components.
• Develop and execute technical improvement plans to increase robustness, reduce defects, and lower cost.
• Interface with CMOs and suppliers; guide cross-functional partners on technical topics.
• Maintain process knowledge base and govern continued process verification.
• Support regulatory submissions, audits, and inspections; manage changes and post-approval activities.
• Lead investigations, root-cause analysis, and improvement projects impacting multiple areas.

Skills

Analytical thinking

Cross-functional collaboration

Project management

Regulatory awareness

Technical ownership

Communication skills

Education

Bachelor's degree in engineering or related field

Job description

Satsuma Pharmaceuticals is a biopharmaceutical company preparing to launch AtzumiTM (dihydroergotamine (DHE) nasal powder), a novel therapeutic product approved in the US for the acute treatment of migraine. AtzumiTM incorporates proprietary advanced powder and device technology (SMART - Simple MucoAdhesive Release Technology™) and is designed to be easy-to-use, easy-to-carry and for quick self-administration.

Position Summary:

The Technical Product Owner supports the technical lifecycle management of AtzumiTM. Reporting to the Senior Director, Operations, this role coordinates and executes technical activities across raw materials, including active pharmaceutical ingredients (API) and excipients; bulk formulation; device components; filling and assembly; and secondary packaging. The role works with cross-functional Satsuma teams, contract manufacturers, and suppliers to improve manufacturing robustness, product quality, operational performance, and supply continuity. The Technical Product Owner is the primary technical interface for AtzumiTM manufacturing, working with CMOs, suppliers, Quality, Regulatory Affairs, and Supply Chain to maintain process control, address technical issues, and support commercial supply. The successful candidate works on issues where analysis of situations or data requires conceptual thinking and an in-depth knowledge of organizational objectives, implementing policies and selecting methods, techniques, and evaluation criteria for obtaining results, and drives the strategy and success of larger projects which contribute to multiple areas of the organization.

Key Responsibilities:

• Serve as the technical owner and subject-matter expert of AtzumiTM across API and excipients, bulk formulation, device components, filling and assembly, and secondary packaging.
• Establish operational objectives, policies, and procedures for technical product ownership activities, delegating assignments and providing guidance to cross-functional partners.
• Serve as the technical interface with CMOs and suppliers. Interact regularly with lower and/or senior management on matters concerning several functional areas and CMOs, requiring the ability to persuade others in sensitive, complex situations while preserving relationships.
• Develop and execute technical improvement plans that increase process and product robustness, reduce variability and defects, improve yield, strengthen supply continuity, and lower cost while maintaining product quality or regulatory compliance.
• Maintain the product and process knowledge base, including critical material attributes, critical quality attributes, critical process parameters, process dependencies, technical risks, and the rationale supporting the approved manufacturing process.
• Establish and govern the continued process verification program, including data collection, performance trending, alert and action limit review, and creation and management of action plans to address risk.
• Provide technical direction and support to CMOs/suppliers in deviations, batch failures, product complaints, nonconformances, supplier defects, atypical trends, and recurring performance issues.Manage manufacturing and supplier changes and support post-approval changes including qualifications, stability, batch record updates, and impact assessments.
• Support the maintenance and reliability of Satsuma-owned manufacturing equipment, including equipment changes, reliability improvements, maintenance and obsolescence planning, critical-spare strategies, and assessment of automation or software changes.
• Support regulatory inspections, partner audits, and internal inspection-readiness activities.
• Author and review technical content supporting post-approval regulatory submissions, regulatory commitments, health-authority questions, audits, and inspections.
• Partner with Quality, Regulatory Affairs, Supply Chain, Commercial, and external partners to prioritize technical work, support supply decisions, and implement changes.
• Drive the strategy and success of larger technical improvement projects which contribute to multiple areas of the organization, implementing policies and selecting methods, techniques, and evaluation criteria for obtaining results.
• Proactively identify, assume, and execute additional responsibilities, initiatives, and special projects as business needs evolve.

Minimum Requirements Education/Experience:

• Bachelor’s degree in chemical, mechanical, biomedical, pharmaceutical, manufacturing, or related engineering; pharmaceutical sciences, chemistry, or another relevant technical discipline.
• Demonstrated ability to work on issues where analysis requires conceptual thinking and in-depth knowledge of organizational objectives, implementing policies and selecting methods and techniques for obtaining results.
• 7+ years of experience in pharmaceutical, biotechnology, medical device, combination-product, Manufacturing Science and Technology (MSAT/MS&T), process engineering, product stewardship, or technical operations roles, including support of commercial or late-stage products.
• Demonstrated experience supporting pharmaceutical or drug-device combination products across multiple unit operations and/or external manufacturing partners.
• Working 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.
• Experience with combination-product design controls, component specifications and drawings, supplier manufacturing processes, device assembly, and device risk-management documentation is preferred.
• Experience leading investigations and improvement projects, statistical analysis, process-capability assessment, and root-cause analysis.
• Working knowledge of applicable FDA, ICH guidelines and requirements.
• Strong project-management, collaboration, and communication skills, including the ability to coordinate CMOs and suppliers, manage multiple priorities, and clearly communicate technical risks and recommendations.
• Experience with dry-powder formulations, nasal or inhalation delivery systems, unit-dose devices, spray-drying, powder filling, automated device assembly, or secondary packaging is preferred.
• Ability to travel to domestic and international manufacturing and supplier sites as business needs require, anticipated at up to 25%.
• Proven ability to advise teams on moderately complex matters and contribute to accountability for outcomes impacting the business segment.
• An equivalent combination of education, training, and relevant experience may substitute for stated qualifications.

Benefits and Pay:

The expected salary range for this position is $150,000.00 - $180,000.00 USD. Actual pay will be determined based on experience, qualifications, and other job-related factors permitted by law.

Satsuma Pharmaceuticals is committed to providing its employees with benefit options that are comprehensive, competitive, and that individual employees can tailor to their and their families’ specific needs. Eligible employees are offered 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, and Company Holidays.

EEO & Employment Eligibility:

Satsuma Pharmaceuticals is committed to building a diverse, equitable, and inclusive company. We provide equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability, or veteran status. Satsuma Pharmaceuticals also complies with all applicable national, state, and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification required of applicable law.