Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Laboratory Setting
Job Description
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Discover Impactful Work:
The Supervisor, Analytical Development, provides leadership and technical oversight within the Analytical Development group. This role is responsible for managing a team of approximately 5–7 scientists/analysts, overseeing day-to-day laboratory operations, and ensuring high-quality, compliant analytical execution. The Supervisor supports method development, validation, and regulatory activities while driving operational efficiency, staff development, and continuous improvement.
What to Expect:
- Manage and lead a team of approximately 5–7 staff members, including workload planning, performance management, coaching, and professional development.
- Oversee day-to-day laboratory operations to ensure timely and compliant execution of analytical activities.
- Schedule activities and allocate resources to meet project timelines and throughput targets
- Compare laboratory results with specifications and determine acceptability, including evaluation of Out-of-Specification (OOS) and Out-of-Trend (OOT) results.
- Ensure compliance with GMP, GLP, safety, and data integrity requirements.
- Author and/or review: OOS investigations, Deviations and Change Controls, Specifications and technical reports, Protocols and validation summaries, SOPs, Regulatory documents (IND, NDA, CMC sections)
- Serve as a technical subject matter expert and support regulatory inspections and client interactions.
- Lead or support root cause investigations, failure analysis, and problem-solving activities.
- Collaborate cross-functionally with Quality, Manufacturing, Regulatory, and clients to implement changes and resolve issues.
- Support internal and external audits and inspections by providing documentation, responding to inquiries, and ensuring audit readiness and compliance.
- Drive continuous improvement initiatives to enhance laboratory efficiency, compliance, and quality systems.
- Maintain knowledge of regulatory expectations, industry trends, and cGMP requirements.
- Ensure all job-related safety training and compliance requirements are met.
Education and Experience:
- Bachelor’s degree in Pharmaceutical Chemistry, Chemistry, Biology, or a related field with 5+ years of relevant experience, or
- Master’s degree with 4+ years of relevant experience, or
- PhD with 3+ years of relevant experience in Analytical Development, Quality Control, or related field
- Experience with OOS, OOT investigations, deviations, CAPA, and change control systems
Knowledge, Skills, Abilities:
- Strong background in analytical techniques including: HPLC, GC, Atomic Absorption, Dissolution, FT-IR, UV, Karl Fischer Titration, IEF (preferred), ELISA (preferred), CGE (preferred), Dot-Blot (preferred).
- Experience with analytical method development, validation, transfer, and verification for drug products and raw materials
- Experience testing for assay, impurities, content uniformity, potency
- Data trending and interpretation of analytical results
- Strong knowledge of GMP, GLP, ICH, and FDA regulatory requirements
- Experience with DEA-controlled substances (preferred)
- Experience with cleaning method validation (preferred)
- Strong organizational, communication, and leadership skills
- Ability to manage multiple priorities and meet deadlines
- Proficiency in Microsoft Office applications
- Demonstrated ability to work independently and collaboratively
- Fluent in English
Benefits
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
Other
Relocation assistance is not provided.
Must be legally authorized to work in the United States now and in the future, without sponsorship.
Must be able to pass a comprehensive background check, which includes a drug screening.