Senior Study Lead, Biopharmaceuticals (GMP)

About the Role

The Senior Study Lead is responsible for overseeing and managing multiple complex or large-scale routine projects (release, stability, or quality control), ensuring seamless interaction with clients and internal leadership to communicate project updates, milestones, and strategic priorities. This role delivers high-quality outputs, conducts thorough reviews and evaluations of data, and prepares comprehensive protocols and reports. The Senior Study Lead is accountable for managing quality records and ensuring strict adherence to regulatory guidelines and scientific standards for routine testing. This position holds decision-making authority for routine investigations, deviations, and risk-based assessments, ensuring scientifically sound and compliant outcomes.

Responsibilities

• Independently draft and/or approve detailed and comprehensive technical documents, perform meticulous data/report reviews, and provide constructive feedback and guidance to Study Leads to ensure high-quality deliverables.
• Design and manage robust project study plans and complex program strategies, ensuring technical accuracy, high-quality outcomes, and alignment with client expectations and business objectives.
• Proactively identify solutions for technical challenges associated with routine testing, develop innovative and effective solutions, and mentor scientists in advanced problem-solving methods.
• Identify and eliminate obstacles, develop strategic improvement plans, and continuously identify opportunities to optimize laboratory processes and project efficiency.
• Lead and oversee the execution and coordination of routine projects using established methods.
• Identify improvement opportunities and collaborate with internal stakeholders to evaluate and implement changes.
• Hold decision-making authority for routine investigations, deviations, and risk-based assessments, ensuring scientifically sound, compliant, and well-documented outcomes.
• Communicate complex technical information concisely and effectively with clients, lead technical visits and discussions, and prepare for audits or site visits.
• Lead audit readiness efforts, ensuring studies, documentation, and processes are inspection-ready; serve as a key contact during audits and drive resolution of audit observations.
• Review and/or approve client deliverable documents, including routine protocols, reports, and quality records.
• Develop and evaluate technical Key Performance Indicators (KPIs), collaborate with clients and internal stakeholders to drive continuous improvement.
• Support comprehensive contract reviews, evaluate scientific proposals, provide recommendations, and estimate resource needs.
• Train and mentor Study Leads and other staff on compliance, audit readiness, and problem-solving techniques, fostering a culture of excellence.
• Ensure overall study quality, data integrity, and compliance across assigned programs, aligning with GMP, regulatory requirements, and internal standards.

Requirements

• Bachelor's degree or equivalent and relevant formal academic/vocational qualification.
• 8+ years of relevant experience or equivalent combination of education, training, and experience.
• Advanced knowledge of routine analytical testing, instrumentation, and laboratory systems.
• Strong understanding of regulatory requirements (e.g., GMP, FDA guidelines).
• Expertise in data evaluation, trend analysis, and interpretation of complex data sets.
• Demonstrated leadership in managing multiple complex projects.
• Proficiency in Microsoft Office applications and laboratory information management systems (LIMS).
• Excellent written and verbal communication skills.
• Ability to conduct root cause analyses and lead investigations.
• Proven ability to identify and implement process improvements.
• Strong attention to detail and commitment to data integrity.
• Ability to build and maintain positive relationships with internal teams and clients.

Qualifications

• Advanced knowledge of routine analytical testing, instrumentation, and laboratory systems.
• Strong understanding of regulatory requirements (e.g., GMP, FDA guidelines).
• Expertise in data evaluation, trend analysis, and interpretation of complex data sets.
• Highly proficient in Microsoft Office applications and Power BI.
• Skilled in the use of laboratory information management systems (LIMS).
• Excellent technical writing and communication skills.
• Ability to mentor and train junior staff.
• Proven track record in process improvement and innovation.

Skills

• Advanced problem-solving and decision-making skills.
• Strong project management and organizational skills.
• Effective communication and collaboration abilities.
• Attention to detail and commitment to quality.
• Ability to work under pressure and manage multiple priorities.

Work Environment

This is a fully onsite role based at our GMP Laboratory in Middleton, WI. The role requires the ability to work upright and stationary for typical working hours, lift and move objects up to 25 pounds, and use standard office equipment and technology. There may be exposure to potentially hazardous elements typically found in laboratory environments. The position demands successful performance under pressure while prioritizing and handling multiple projects.

Additional Information

This role requires legal authorization to work in the United States without sponsorship. Candidates must pass a comprehensive background check, including a drug screening. Relocation assistance is not provided, and any relocation costs will be the responsibility of the candidate.