<p>Work Schedule</p> <p>Standard (Mon-Fri)</p> <p>Environmental Conditions</p> <p>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.)</p> <p>Job Description</p> <p>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.</p> <p>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.</p> <p>A Day in the Life</p> <p>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.</p> <p>Essential Functions:</p> <ul> <li> <p>Provide management and direction to laboratory staff and resources for project activities and needs.</p> </li><li> <p>Coordinate daily operations to supervise quality and project timelines.</p> </li><li> <p>Assist in preparation and implementation of company policies, quality systems, and training programs.</p> </li><li> <p>Ensure responsiveness to customers and overall client happiness.</p> </li><li> <p>Plan and supervise the progress and quality of projects using financial and quality management tools.</p> </li><li> <p>Prepare, review, and approve study protocols, project status reports, final study reports, and other project-related technical documents.</p> </li><li> <p>Design experimental studies and participate in technical troubleshooting.</p> </li><li> <p>Review data for technical quality and compliance to protocols, methods, and SOPs.</p> </li><li> <p>Review and approve laboratory investigations, deviations, and QA facility and data audits.</p> </li><li> <p>Lead client and FDA audits.</p> </li><li> <p>Allocate, schedule, and lead laboratory resources for group project activities.</p> </li><li> <p>Respond to client questions and needs, lead client technical meetings.</p> </li><li> <p>Assist in preparation of proposals by providing project definition.</p> </li><li> <p>Identify new opportunities within client base and work with business development to pursue opportunities.</p> </li><li> <p>Coordinate and prioritize project activities with internal functional groups and support functions.</p> </li><li> <p>Prepare and implement PPD SOPs and company operational policies, ensuring adherence and making recommendations for quality system improvements.</p> </li><li> <p>Interact frequently with internal personnel and outside representatives at various levels.</p> </li></ul> <p>Keys to Success</p> <p>Education</p> <ul> <li>Bachelor's degree in lab sciences such as biology, biochemistry, immunology, chemistry, molecular biology or similar </li></ul> <p>Experience</p> <ul> <li> <p>Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years') or equivalent combination of education, training, & experience.</p> </li><li> <p>1+ years of management responsibility</p> </li></ul> <p>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.</p> <p>Knowledge, Skills, Abilities</p> <ul> <li> <p>Proven experience working in a GMP-regulated lab environment preferred</p> </li><li> <p>Demonstrated knowledge of HPLC strongly preferred</p> </li><li> <p>Demonstrated ability to collaborate with external clients or customers, providing exceptional service and communication</p> </li><li> <p>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).</p> </li><li> <p>Ability to cultivate a collaborative work environment with a team and across business areas</p> </li><li> <p>Effective written and oral communication skills as well as presentation skills</p> </li><li> <p>Proven problem solving and troubleshooting abilities</p> </li><li> <p>Understanding of basic financial terms and definitions as it applies to the business</p> </li><li> <p>Ability to independently develop project proposals/plans</p> </li><li> <p>Project and time management skills</p> </li><li> <p>Proven ability to identify and implement common efficiencies across multiple programs/projects</p> </li><li> <p>Demonstrated understanding of the bid process and can utilize expertise of others to develop programs to meet unique client needs</p> </li><li> <p>Proven ability to cope with a dynamic work environment</p> </li></ul> <p>Benefits</p> <p>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!</p> <p>We provide comprehensive benefits including comprehensive training, annual incentive plan bonus, medical, dental, vision, pharmacy, employee assistance program, wellness program options and more!</p> <p>Other benefits include:</p> <ul> <li> <p>401k with matching contributions, life insurance, long term and short term disability insurance, flexible medical and dependent care spending accounts.</p> </li><li> <p>Work life balance programs including paid time off for vacation/sick time, paid holidays, floating holiday.</p> </li><li> <p>Wellness benefits including health and wellness programs, fitness facility access or discount, health coaching and more.</p> </li></ul> <p>Work Environment</p> <p>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:</p> <ul> <li> <p>Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.</p> </li><li> <p>Able to work upright and stationary and/or standing for typical working hours.</p> </li><li> <p>Able to lift and move objects up to 25 pounds.</p> </li><li> <p>Able to work in non-traditional work environments.</p> </li><li> <p>Able to use and learn standard office equipment and technology with proficiency.</p> </li><li> <p>May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.</p> </li><li> <p>Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.</p> </li></ul> <p>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.</p> <p>Apply today! http://jobs.thermofisher.com</p> <p>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.</p> <p>Accessibility/Disability Access</p> <p>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.</p> <ul> <li>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. </li></ul>