Manager, Analytical Method Validation

Sterling Pharma Solutions Limited; Town of Germantown (WI); On-site; USD 140,000 - 190,000; Full time

Job summary

Sterling Pharma Solutions Limited is seeking a Manager, Analytical Method Validation to lead validation, verification, transfer, and lifecycle management for small molecule API programs in a fast-paced CDMO environment.

You will provide scientific leadership, oversee validation documentation, and collaborate with R&D, Quality, Regulatory, and Project Management to ensure regulatory compliance and customer satisfaction. This role requires strong leadership and strategic thinking.

Qualifications

• Bachelor’s degree in a relevant scientific discipline with pharma exposure.
• Minimum 8 years in analytical development/validation or QC in pharma.
• 3–5+ years of direct people leadership experience.
• Experience authoring and reviewing validation documents in cGMP.

Responsibilities

• Lead validation, verification, transfer, and lifecycle activities for development and commercial programs.
• Develop validation strategies aligned with ICH, FDA, EMA, USP, and cGMP.
• Oversee validation protocols, reports, and method transfer packages.
• Represent analytics during customer meetings, audits, and site visits.
• Coach and develop analytical staff; recruit and retain talent.
• Manage budgets, equipment investments, and resource planning.
• Maintain data integrity and ensure inspection readiness.

Skills

Analytical method validation

Method transfer

Regulatory liaison

Team leadership

Education

Bachelor's degree in Chemistry/Analytical Chemistry/Pharmaceutical Sciences

Tools

Empower

Chromeleon

LIMS

Job description

Summary of Role

The Manager, Analytical Method Validation is accountable for leading analytical method validation, verification, transfer, and lifecycle management activities in support of small molecule API development, technology transfer, and commercial manufacturing programs within a fast-paced CDMO environment.

The incumbent provides technical and personnel leadership for the Analytical Method Validation group and is responsible for ensuring analytical methods are validated, transferred, and maintained in accordance with current regulatory expectations, client requirements, and internal quality standards.

The position partners closely with R&D, Quality, Regulatory, Business Development, and Project Management teams to ensure successful execution of customer programs.

Essential Functions

• Provides leadership and technical oversight for analytical method validation, verification, qualification, transfer, and lifecycle management activities supporting development and commercial programs.
• Develops and implements analytical validation strategies consistent with ICH, FDA, EMA, USP, and cGMP requirements.
• Oversees execution and review of validation protocols, reports, method transfer packages, and supporting technical documentation.
• Serves as the primary technical representative for analytical validation activities during customer meetings, project reviews, audits, and site visits.
• Partners with Business Development and Project Management teams to support proposals, project scoping, technical assessments, and customer engagements.
• Provides scientific leadership for troubleshooting analytical methods and resolution of complex analytical challenges.
• Ensures data integrity, inspection readiness, and compliance with applicable regulatory and company requirements.
• Reviews and approves SOPs, specifications, protocols, reports, validation packages, and controlled documents.
• Provides direct supervision, coaching, performance management, and career development for Analytical Method Validation scientists and technical staff.
• Participates in recruiting, interviewing, hiring, onboarding, and retention activities.
• Develops, manages, and monitors departmental operating and capital budgets.
• Evaluates and recommends investments in laboratory equipment, software, instrumentation, and personnel resources.
• Manages project prioritization, laboratory workload, and resource utilization across multiple customer programs.
• Builds and maintains strong customer relationships while ensuring high levels of scientific quality, communication, and customer satisfaction.
• Identifies and implements continuous improvement initiatives.
• Ensures timely completion and compliance with cGMP, safety, and all other relevant company training requirements.

Key Competencies

• Expert knowledge of analytical method development, validation, verification, transfer, and lifecycle management.
• Advanced knowledge of HPLC, UPLC, GC, KF, FTIR, LC‑MS, GC‑MS, ICP‑MS and related analytical techniques.
• Strong understanding of ICH validation guidelines, cGMP requirements, and global regulatory expectations.
• Demonstrated ability to lead validation strategies and defend analytical approaches during audits and inspections.
• Demonstrated ability to lead, motivate, and develop high-performing scientific teams.
• Strong business acumen with the ability to balance customer expectations, project priorities, resource utilization, and financial performance.
• Demonstrated experience managing departmental budgets and capital expenditures.
• Proven ability to build productive customer relationships and successfully represent analytical functions in client-facing environments.
• Excellent written and verbal communication, negotiation, and influencing skills.
• Demonstrated commitment to quality, compliance, safety, and continuous improvement.

Education and Experience

Required

• Bachelor's degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or related scientific discipline.
• Minimum 8 years of pharmaceutical industry experience in analytical development, analytical validation, or quality control laboratories.
• Minimum 3-5 years of direct people leadership experience.
• Experience authoring and reviewing validation protocols, reports, and method transfer documentation.
• Experience operating within a cGMP-regulated pharmaceutical environment.
• Experience participating in customer meetings, technical reviews, and audits.

Preferred

• Advanced degree (M.S. or Ph.D.) in a relevant scientific discipline.
• Experience within a pharmaceutical CDMO environment.
• Experience supporting business development activities and proposal generation.
• Experience managing departmental budgets and capital planning activities.
• Experience supporting client audits, regulatory inspections, and regulatory submissions.
• Experience with Empower, Chromeleon, LIMS, or similar laboratory systems.

Travel Requirement

Up to 5% travel may be required for customer, supplier, training or business needs.

Other Qualifications, Skills and Abilities

• This position is eligible for a flexible schedule.
• This position is not eligible for remote / hybrid work location.

Diversity and Inclusion

Sterling values diversity and we are committed to creating an inclusive environment for all employees. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion, sex, pregnancy, age, national origin, physical or mental disability, past or present military service, marital status, gender identification or expression, medical condition (including genetic characteristics) or any other protected characteristic as established by law.

Why Consider Sterling?

Sterling Pharma Solutions is a global contract development and manufacturing organisation (CDMO) with more than 50 years’ experience in developing and manufacturing Active Pharmaceutical Ingredients (APIs). This is complimented by Antibody Drug Conjugate (ADC) research and development bioconjugation services.

We are a fast growing, dynamic business with facilities in the UK and the US, where we employ more than 800 talented and passionate people who support our customers in bringing new medicines to market, improving and saving the lives of patients.

Our culture and our way of working is what really sets us apart as a business; we aim to deliver an exceptional experience to our customers and our employees. You can expect to be part of a supportive team, all working towards a shared goal: to deliver first‑class science and service to our customers every day.