Adherence to all Good Manufacturing Practices (GMP) Safety Standards
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.
Key responsibilities:
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 development for Small Molecule New Chemical entities and Investigational Medicinal Products.
This role is Fully On-site
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.
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.
Working 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 with
proficiency.
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.
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!
