Group Leader - Bioanalytical

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 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.

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.

Discover Impactful Work:

Provides management and direction to laboratory staff and resources for project activities and needsoversee daily operations to monitor quality and project timelines and assist in preparation andimplementation of company policies quality systems and training programs. Ensures responsiveness tothe customer and overall client satisfaction. Plans and monitors the progress and quality of projects byutilizing the financial and quality management tools available at PPD.

A Day in the Life:

Prepares reviews and approves study protocols project status reports final
study reports and other project-related technical documents.
Designs experimental study and participates in technical troubleshooting.
Reviews data for technical quality and compliance to protocols methods and
SOPs. Reviews and approves laboratory investigations deviations and QA facilityand data audits. Leads client and FDA audits.
Allocates schedules and manages laboratory resources for groups project
activities and updates project status. Reviews timesheet reports for billing
accuracy.
Responds to clients questions and needs; leads client technical meetings.
Assists in preparation of proposals by provided project definition.
Identifies new opportunities within client base and ability to work with businessdevelopment to pursue opportunities.
Coordinates and prioritizes project activities with internal functional groups
(physical testing analytical development microbiology etc.) and support
functions (QA sample management etc.).
Assists management in their responsibilities.
Prepares and implements PPD SOPs and company operational policies. Ensuresadherence and makes recommendations to quality system improvements.

Keys to Success:

Previous experience that provides the knowledge skills and abilities to perform the job (comparable to5 years) or equivalent and relevant combination of education training & experience.

1 year of leadership responsibility

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:
Proven leadership skills
Ability to cultivate a collaborative work environment with a team
Effective negotiating skills
Demonstrated knowledge of QA metrics of program base; ability to write and recommend changes toPPD SOPs
Ability to troubleshoot multiple systems/methodologies
Ability to independently optimize analytical methods
Understanding of basic financial terms and definitions as it applies to the business
Understanding of proposal and project scope as it relates to pricing resource management and theimpact on business
Project and time management skills
Effective written and oral communication skills as well as presentation skills
Ability to train and mentor junior staff

Work Environment:

Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. 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.