R&D Analytical Development Supervisor

Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team youll 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 worlds 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 57 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 57 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:

• Bachelors degree in Pharmaceutical Chemistry Chemistry Biology or a related field with 5 years of relevant experience or
• Masters 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.