Work Schedule

First Shift (Days)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

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.

A Day in the Life

As a Senior Group Leader you will provide oversight and supervision of staff and resources performing pharmaceutical development studies such as method development and validation, stability, QC, etc. You will manage the work activities of group and associate group leaders, resource planning and allocation, client communication, technical document generation and review, mentoring technical staff and troubleshooting method and product-related issues. You will ensure the compliance of work performed within the laboratory as well as work with your manager to meet the financial goals of the organization.

Essential Functions:

Reviews and approves study protocols, project status reports, final study reports and other project related technical documents. Designs experimental studies and participates in technical troubleshooting.

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

Reviews data for technical quality and compliance to protocols, methods and SOPs. Approves laboratory investigations, deviations, QA facility and data audits. Leads client and FDA audits.

Responds to clients questions and needs; leads client technical meetings. Provides recommendations to clients on analytical and compliance issues.

Prepares and approves proposals, project definition and pricing. Participates in project definition and negotiations with client on timelines and budget.

Identifies business opportunities at conferences, workshops, within the community, through client interaction, etc. Participates in technical sales and marketing; prepares technical marketing materials. Works with business development as technical representative for client visits/discussions.

Prepares and implements PPD SOPs and company operational policies. Ensures adherence and makes recommendations to quality system improvements.

Accountable for group's knowledge and application of good practices pertaining to GMP/GLP and / or other laboratory / client requirements.

Participates in bi-annual SOP review & change. Ownership of changes needed to comply with SOPs.

Regularly communicates to staff quality related issues and items for staff development and implements quality improvements.

Keys to SuccessEducation

Bachelor's degree in lab sciences such as biology, biochemistry, immunology, chemistry, molecular biology or similar

Experience

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

2+ years of management 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, Abilities

Proven experience working in a GMP-regulated lab environment

Demonstrated ability to collaborate with external clients or customers, providing exceptional service and communication

Strong background in identifying and implementing process improvements or efficiency enhancements, including experience with financial forecasting and quality management practices such as trending and CAPAs (Corrective and Preventive Actions).

Previous experience with biopharmaceutical testing preferred

Ability to cultivate a collaborative work environment with a team and across business areas

Effective written and oral communication skills as well as presentation skills

Proven problem solving and troubleshooting abilities

Understanding of basic financial terms and definitions as it applies to the business

Ability to independently develop project proposals/plans

Project and time management skills

Proven ability to identify and implement common efficiencies across multiple programs/projects

Demonstrated understanding of the bid process and can utilize expertise of others to develop programs to meet unique client needs

Proven ability to cope with a dynamic work environment

Benefits

Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

We provide comprehensive benefits including comprehensive training, annual incentive plan bonus, medical, dental, vision, pharmacy, employee assistance program, wellness program options and more!

Other benefits include:

401k with matching contributions, life insurance, long term and short term disability insurance, flexible medical and dependent care spending accounts.

Work life balance programs including paid time off for vacation/sick time, paid holidays, floating holiday.

Wellness benefits including health and wellness programs, fitness facility access or discount, health coaching and more.

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.