Senior Scientist - Cleaning Verification

at  Thermo Fisher Scientific

JOB DESCRIPTION

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.
Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to leverage the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits.

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 AND 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.

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.

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.