Job Description

*Work Schedule* Standard (Mon-Fri)*Environmental Conditions* 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. Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission – to enable our customers to make the world healthier, safer, and cleaner. 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:*
• Lead/support ALCM (analytical method lifecycle management) projects including late stage and post-marketing approve analytical activities such as method validation/verification and method transfer
• Be accountable for the success of ALCM projects/activities and ensure on-time deliverables to meet program commitments
• Be a key contributor to analytical method continuous improvement and lifecycle management
• Participate in troubleshooting and the investigations during routine manufacturing and quality control operations
• Be primary SME for microbiological/analytical testing and method performance implemented at CDMOs and contract testing labs
• Support program collaborations with internal functions including Analytical Development, Process Development, Commercial Manufacturing, Supply Chain, and Quality teams
• Support regulatory submissions and responses to health agency inquiry
• Education and Experience:*
• Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology or similar
• *Scientist:* Previous experience that provides the knowledge, skills, and abilities to perform the job *(comparable to 2+ years’)*
• OR *Masters* degree
• *Sr. Scientist:* Previous experience that provides the knowledge, skills, and abilities to perform the job *(comparable to 4+ years’)*
• OR Masters 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:*
• Demonstrated expertise in analytical method development, qualification, validation/verification and transfer for biologics and/or cell gene therapy drug products, with a focus on the safety release methods
• Working experience in late stage or commercial environment with a good understanding of GMP operation is required
• Hands-on experience with compendial microbial safety methods (e.g Sterility, Endotoxin, Mycoplasma, etc) and alternative microbiological methods/technology (e.g Mycoplasma qPCR, BAC-T Alert, Endosafe)
• Experience in method suitability transfers for compendial methods
• Experience and knowledge of regulatory requirements, USP/EU guidelines for compendia and ICH guidance related to safety methods is required
• Experience in managing contract testing sites (CTO/CDMO) is recommended
• Ability to prioritize objectives from multiple projects, adhere to scheduled timelines while maintaining flexibility and efficiency
• Sufficient technical writing skill is a must
• Excellent communication skills with the proven ability to work with internal and external partners is a plus
• 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!

Job Tags

Full time, Contract work, Work experience placement,

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