Senior Manager, Technical Product Owner

Satsuma Pharmaceuticals•Durham, NC

21d•$150,000 - $180,000

About The Position

Satsuma Pharmaceuticals is 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.

Requirements

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 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.
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.

Nice To Haves

Experience with combination-product design controls, component specifications and drawings, supplier manufacturing processes, device assembly, and device risk-management documentation is preferred.
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.

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.