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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in technical lifecycle management, process validation, and regulatory compliance within the pharmaceutical and biotechnology sectors. Proven ability to lead technical improvement projects, manage supplier relationships, and ensure product quality across multiple manufacturing operations.
Highest-signal resume keywords
Technical Lifecycle ManagementProcess ValidationRegulatory ComplianceProject ManagementStatistical Analysis
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Process ValidationContinued Process VerificationDeviation ManagementRoot-Cause AnalysisStatistical AnalysisChange ControlRisk ManagementProduct Quality ReviewTechnical WritingManufacturing Process Knowledge
Soft Skills
CollaborationCommunicationProject ManagementProblem-SolvingLeadership
Tools & Technologies
CAPA SystemsFDA GuidelinesICH GuidelinesDevice AssemblyAutomated Device AssemblyDry-Powder FormulationsNasal Delivery SystemsInhalation Delivery SystemsStatistical SoftwareManufacturing Equipment
Industry Keywords
PharmaceuticalBiotechnologyMedical DeviceCombination ProductsMSAT/MS&TTechnical OperationsQuality AssuranceRegulatory AffairsSupply Chain ManagementProduct Stewardship
Tech Stack
Tools & technologiesAssembly
About the role
Key responsibilities & impact- Support the technical lifecycle management of Atzumi™
- Serve as technical owner and subject-matter expert 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
- Serve as technical interface with contract manufacturing organizations and suppliers
- Develop and execute technical improvement plans to improve robustness, reduce variability and defects, improve yield, strengthen supply continuity, and lower cost while maintaining quality and compliance
- Maintain the product and process knowledge base, including critical material attributes, critical quality attributes, critical process parameters, process dependencies, technical risks, and manufacturing-process rationale
- Establish and govern continued process verification, including data collection, performance trending, alert and action-limit review, and action-plan management
- Provide technical direction and support for deviations, batch failures, complaints, nonconformances, supplier defects, atypical trends, and recurring performance issues
- Manage manufacturing and supplier changes and support post-approval changes, qualifications, stability, batch-record updates, and impact assessments
- Support maintenance and reliability of Satsuma-owned manufacturing equipment, including equipment changes, reliability improvements, maintenance and obsolescence planning, critical-spare strategies, and automation or software-change assessments
- Support regulatory inspections, partner audits, and internal inspection-readiness activities
- Author and review technical content for post-approval 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 larger technical improvement projects spanning multiple organizational areas
- Proactively assume additional responsibilities, initiatives, and special projects as business needs evolve
- Report to the Senior Director, Operations
Requirements
What you’ll need- Bachelor’s degree in chemical, mechanical, biomedical, pharmaceutical, manufacturing, or related engineering; pharmaceutical sciences, chemistry, or another relevant technical discipline
- 7+ years of experience in pharmaceutical, biotechnology, medical device, combination-product, MSAT/MS&T, process engineering, product stewardship, or technical operations roles, including support of commercial or late-stage products
- 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 and ICH guidelines and requirements
- Strong project-management, collaboration, and communication skills
- Ability to coordinate CMOs and suppliers, manage multiple priorities, and communicate technical risks and recommendations clearly
- 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
- Must satisfy applicable work authorization and employment eligibility requirements
Benefits
Comp & perks- 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