FSP - Sr. Stability Coordinator

Work Schedule

Environmental Conditions

Job Description

At Thermo Fisher Scientific youll 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 lifechanging 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 fulltime benefits.

The Senior Stability Coordinator is responsible for providing stability program administration support for stability studies that are managed by the Global Biopharmaceutical Stability department. And for the overall department administration support.

Key responsibilities:

• Communication and tracking of commercial batch requirements into the stability program to support the marketed product stability program and other commitments related to product initiatives and business needs.
• Prepare and ship stability samples to contract laboratories for storage and testing and to other BMS sites as required. Ensures samples are shipped per current regulations (i.e. hazardous and nonhazardous) and monitors the shipment for temperature excursions.
• Support stability storage chamber maintenance by working with third party contractors and site maintenance personnel. Review system and responding to chamber related events.
• Enters test results from contract laboratories into the stability study management systems.
• LIMS activities to start stability studies and maintain updated samples inventory.

Education and Experience:

• Bachelors degree in lab sciences such as Chemistry Microbiology or similar
• 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:

• Experience with stability programs desired.
• Solid understanding and knowledge of cGMPs and regulatory principles.
• Excellent verbal written and interpersonal communication skills are essential.
• Able to work independently and as part of a teambased environment.
• Proficient computer software application skills.
• Demonstrated ability for accurate recordkeeping thorough documentation attention to detail and efficient organization/management of records and time.

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 nontraditional 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 forwardthinking organization and outstanding career and development prospects. We offer an exciting company culture that stands for integrity intensity involvement and innovation!