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Group Leader - Biopharmaceuticals (GMP)

Location Middleton, ウィスコンシン州, アメリカ合衆国 Job Id R-01305370 Job Type フルタイム Category ラボラトリーサービス Remote すべてオンサイト
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JOB DESCRIPTION

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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.

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 needs, supervise daily operations to monitor quality and project timelines, and assist in preparation and implementation of company policies, quality systems and training programs. Ensures responsiveness to the customer and overall, client satisfaction. Plans and monitors the progress and quality of projects by applying 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 facility and data audits. Leads client and FDA audits.

  • Allocates, schedules and manages laboratory resources for group's project activities and updates project status. Reviews timesheet reports for billing accuracy.

  • Responds to client's 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 business development 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. Ensures adherence and makes recommendations to quality system improvements.

Keys to Success:

Education

  • Bachelor's degree or equivalent and relevant formal academic / vocational qualification

Experience

  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years) or equivalent and relevant combination of education, training, & experience.

  • 1+ year of leadership experience

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, Abilities

  • Previous experience as a supervisor or manager

  • Demonstrated knowledge of HPLC, CE, or ELISA preferred

  • Ability to cultivate a collaborative work environment with a team

  • Previous experience in GMP Lab or regulated lab environment preferred

  • Effective negotiating skills

  • Proven knowledge of QA metrics of program base; ability to write and recommend changes to PPD 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 the impact 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.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.

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