Senior Scientist - Cleaning Verification

As the world leader in serving science, our work is more than something that fills our days – what we do has great purpose. Our industry-leading scale means unparalleled commercial reach, unique customer access and a global footprint. Our broad customer base, from research to clinical to commercial production means you can have a broad and meaningful impact here at Thermo Fisher Scientific. All while working in an environment where you will be supported, valued and rewarded for your performance.

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner, and safer. Whether our customers are accelerating life sciences research, solving sophisticated analytical challenges, growing efficiency in their laboratories, improving patient health through diagnostics, or the development and manufacture of life-changing therapies, we are here to support them. Our global team of more than 100,000 colleagues delivers an outstanding combination of innovative technologies, purchasing convenience, and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations!

Scientist - Bioanalytical

As a Senior Scientist, you will be part of the Analytical Regulated Testing GMP team within the Analytical Strategy & Operations department. You will perform pharmaceutical manufacturing equipment cleaning verification cGMP activities, analytical method validation, and provide analytical support for clinical and commercial development for Small Molecule New Chemical entities and Investigational Medicinal Products.

Job Description

Primary responsibility will be to support the Pharmaceutical manufacturing equipment cleaning verification (CV) activities that includes:

• Development/validation of Total Organic Carbon (TOC) and Liquid Chromatography (HPLC) methods
• Conducting and reviewing CV sample analysis
• Authorizing CV method/validation reports and performing change control associated with the method revisions
• Maintenance of TOC/HPLC instruments
• Assess impacts to CV testing as a result of clinical manufacturing and compound permitted daily exposure limit changes
• Collaborate with clinical manufacturing for periodic procedure revisions and assessment of risks
• Performs analytical cGMP activities and provide technical expertise for evaluation and feedback of methods.
• Provides technical expertise and troubleshooting for technical problems and investigations.
• Participates in the preparation and the critically review of regulatory filings including evaluation of data from collaborator labs.
• Technology transfer of analytical methods to external BMS partners
• Provides input into audit readiness and expertise for internal and regulatory inspections.
• Effective teamwork and communication with the CMC sub teams to ensure all API and drug product release testing, stability testing and filing requirements meet associated clinical timelines.

Qualifications

Education and Experience

• Bachelor's degree in analytical chemistry, organic chemistry, biochemistry or Pharmacy and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4+ years’)
• OR Master’s degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’)
• OR PhD

In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills, Abilities

• Extensive pharmaceutical equipment cleaning verification knowledge and experience
• Demonstrated knowledge of the IND and NDA validation and troubleshooting of chromatographic separation methods used to analyze API and drug product.
• Excellent interpersonal communication skills with capability of interfacing with multi-disciplinary teams.
• Experience with notebook review and regulatory submissions.
• Demonstrate a solid understanding of cGMP compliance, regulatory agency requirements and ICH compliance.
• Ability to adapt to change, lead multiple projects optimally meeting timelines.
• Able to find opportunities and implement solutions to improve efficiency, productivity and quality/compliance.
• Strong verbal and written communication skills to optimally connect with key partners both internally and externally.
• Able to influence teams and seek opportunities to develop new and different ways to resolve project challenges.

Work Environment

Below is listed the working environment/requirements for this role:

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary and/or standing for typical working hours.
• Able to lift and move objects up to 25 pounds
• Able to work in non-traditional work environments.
• Able to use and learn standard office equipment and technology withproficiency.
• May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.