Overview of Position
Orion Specialty Labs is seeking an experienced laboratory leader to design, build, qualify, and operate a new analytical Quality Control laboratory supporting an FDA-registered 503B outsourcing facility. The Senior Manager, Quality Control - Laboratory Startup & Analytical Sciences will establish the laboratory master plan, analytical testing strategy, staffing model, capital budget, equipment platform, computerized systems, and compliant operating procedures from the ground up. The role will also lead the laboratory toward ISO/IEC 17025 accreditation, an uncommon and differentiating capability within the 503B sector.
The successful candidate will bring hands-on analytical expertise, startup leadership, deep knowledge of cGMP laboratory controls, and direct experience supporting FDA inspections of 503B or sterile pharmaceutical operations. This position requires a leader who can move effectively between strategy, project execution, technical problem-solving, and day-to-day team development.
Essential Duties and ResponsibilitiesLaboratory Strategy, Startup, and Capital Execution
· Develop and execute the analytical laboratory master plan, including laboratory layout and workflows, testing capabilities, make-versus-buy strategy, staffing plan, capital budget, implementation schedule, and readiness milestones. Lead selection, purchase, installation, qualification, calibration, maintenance, and lifecycle planning for Waters UPLC/HPLC systems, Empower chromatography data systems, Agilent GC systems, GC-MS, LC-MS/MS, dissolution, UV-Vis, FTIR, Karl Fischer, TOC, and other analytical instrumentation.
Analytical Sciences and Method Lifecycle Management
· Lead analytical method development, optimization, transfer, verification, validation, and continued performance monitoring for raw materials, in-process samples, finished products, cleaning validation samples, and stability studies. Ensure methods are scientifically sound and compliant with ICH Q2(R2), USP <621>, USP <1225>, USP <1226>, applicable compendial requirements, and FDA expectations. Establish analytical lifecycle management practices, including method risk assessments, robustness, system suitability, trend review, and controlled method improvements.
Quality Systems, Data Integrity, and Laboratory Compliance
· Author, review, approve, and implement laboratory SOPs, specifications, protocols, reports, sampling plans, worksheets, and technical standards. Establish compliant laboratory controls for OOS, OOT, deviations, CAPA, change control, reference standards, reagents, instrument logbooks, audit trails, electronic records, and ALCOA+ data integrity. Lead implementation and administration of Empower, LIMS, and related laboratory computerized systems, including validation, access controls, audit-trail review, and ongoing governance.
Organization Building and Operational Leadership
· Recruit, hire, train, mentor, and retain a high-performing team of chemists, scientists, and laboratory support personnel. Establish role-based qualification curricula, competency assessments, performance metrics, workload planning, succession development, and a culture of scientific rigor, accountability, safety, and continuous improvement. Provide hands-on technical guidance during laboratory startup and early commercial operations.
Regulatory Readiness, ISO/IEC 17025, and External Laboratory Oversight
· Lead laboratory inspection readiness and serve as the primary QC representative during FDA inspections, state regulatory inspections, customer audits, and accreditation assessments. Candidates should have successfully led or served as a key laboratory contributor during FDA inspections of a 503B or sterile pharmaceutical facility without significant laboratory observations. Develop and execute the roadmap for ISO/IEC 17025 accreditation, including the laboratory quality manual, competency framework, measurement uncertainty where applicable, traceability, proficiency testing, internal audits, and management review. Qualify and oversee contract laboratories, including quality agreements, method transfers, performance monitoring, investigations, and data review.
Stability Program and Business Support
· Design and manage ICH-aligned stability programs, including protocol development, chamber strategy, sample pulls, testing schedules, trend analysis, excursions, annual stability commitments, and shelf-life support. Partner with Quality Assurance, Manufacturing, Validation, Regulatory, Supply Chain, and Product Development to support product launches, investigations, process validation, continued process verification, and reliable batch disposition decisions.
Qualifications for Education and Experience
· Bachelor's degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, or a related scientific discipline; an advanced degree is preferred.
· Minimum of 6 years of progressive pharmaceutical Quality Control or Analytical Sciences experience, including at least 3 years leading laboratory personnel, projects, or functions.
· Direct experience in a 503B outsourcing facility and experience within sterile pharmaceutical manufacturing are strongly preferred.
· Demonstrated experience establishing, expanding, or remediating a pharmaceutical analytical laboratory in a startup, greenfield, or rapid-growth environment.
· Demonstrated experience with capital planning, vendor selection, equipment procurement, instrument qualification (URS/DQ/IQ/OQ/PQ), computerized system validation, and laboratory operational readiness.
· Proven hands-on knowledge of Waters UPLC/HPLC and Empower, Agilent GC, LC-MS/MS, GC-MS, and associated troubleshooting, maintenance, data review, and compliance controls.
· Demonstrated experience with analytical method development, transfer, verification, and validation under ICH Q2(R2), USP <621>, USP <1225>, USP <1226>, and related regulatory expectations.
· Experience leading or materially supporting FDA inspections involving 503B or sterile pharmaceutical laboratory operations, preferably with no significant laboratory observations.
· Working knowledge of 21 CFR Parts 210 and 211, USP standards, FDA data-integrity expectations, ALCOA+, OSHA requirements, and applicable ICH guidance.
· Experience developing or operating within an ISO/IEC 17025-accredited laboratory is highly preferred.
Preferred Skills and Leadership Attributes
· Ability to translate business and product strategy into a practical laboratory roadmap, capital plan, and phased implementation schedule.
· Strong scientific judgment and the ability to review complex chromatographic and mass spectrometry data, identify technical risks, and make defensible decisions.
· Excellent written communication, including SOPs, protocols, investigations, validation reports, inspection responses, and executive-level updates.
· Demonstrated ability to build teams, establish expectations, coach technical staff, and lead effectively in a fast-paced startup environment with evolving priorities.
· Strong project management, vendor management, budgeting, negotiation, and cross-functional collaboration skills.
· Working knowledge of Lean, Six Sigma, laboratory capacity planning, and continuous improvement principles is preferred.
Measures of Success
· Laboratory startup milestones are delivered safely, compliantly, on schedule, and within the approved capital budget.
· Instrumentation, methods, computerized systems, SOPs, and personnel are qualified before commercial testing begins.
· Testing is accurate, timely, scientifically defensible, and inspection-ready, with strong right-first-time and investigation performance.
· The laboratory achieves and maintains a sustainable state of FDA and cGMP readiness and progresses according to the approved ISO/IEC 17025 accreditation roadmap.
· The QC organization develops sufficient internal capability while maintaining effective, compliant oversight of external contract laboratories.
Work Environment and Physical Requirements
This role operates in office, analytical laboratory, warehouse, and pharmaceutical manufacturing environments. The employee must be able to wear required personal protective equipment, work safely around laboratory chemicals and instrumentation, and occasionally lift or move laboratory supplies and equipment components weighing up to 25 pounds. Reasonable accommodations may be made for qualified individuals with disabilities.
Compensation and Benefits
Orion Specialty Labs offers a competitive compensation and benefits package commensurate with experience, which may include performance-based incentives, health benefits, paid time off, retirement benefits, professional development support, and relocation assistance, as applicable.
Equal Employment Opportunity
Orion Specialty Labs is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, sex, pregnancy, national origin, age, disability, genetic information, veteran status, sexual orientation, gender identity or expression, or any other status protected by applicable law.
Pay: $93,814.54 - $164,808.91 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Professional development assistance
- Retirement plan
Work Location: In person
