Description

Work ScheduleStandard (Mon-Fri)Environmental ConditionsAdherence to all Good Manufacturing Practices (GMP) Safety StandardsJob Description<div><div>Group Leader, Pharma </div><div>At PPD, part of 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. </div><div>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, our work spans laboratory, digital and decentralized clinical trial services. </div><div>Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future. </div><div>Location/Division Specific Information </div><div>Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic guides. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations. </div><div>Discover Impactful Work: </div><div>The role of Group Leader is to 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 Associate Group Leaders, resource planning and allocation, client communication, technical document generation and review, mentoring technical staff and troubleshooting method and product-related issues. Ensures the compliance of work performed within the laboratory as well as working with manager to meet the financial goals of the organization. </div><div> </div><div>A day in the Life </div><div><ul><li>Prepares, reviews, and approves study protocols, project status reports, final study reports and other project-related technical documents. </li></ul></div><div><ul><li>Designs experimental study and participates in technical troubleshooting. </li></ul></div><div><ul><li>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. </li></ul></div><div><ul><li>Allocates, schedules, and manages laboratory resources for group's project activities and updates project status. Reviews timesheet reports for billing accuracy </li></ul></div><div><ul><li>Responds to clients questions and needs; leads client technical meetings. </li></ul></div><div><ul><li>Assists in preparation of proposals by provided project definition. </li></ul></div><div><ul><li>Identifies new opportunities within client base and ability to work with business development to pursue opportunities. </li></ul></div><div><ul><li>Coordinates and prioritizes project activities with internal functional groups (physical testing, analytical development, microbiology, etc.) and support functions (QA, sample management, etc.). </li></ul></div><div><ul><li>Assists management in their responsibilities. </li></ul></div><div><ul><li>Prepares and implements PPD SOPs and company operational policies. Ensures adherence and makes recommendations to quality system improvements. </li></ul></div></div><div><div><ul><li>Coordinating and prioritizing project activities with internal functional groups (physical testing, analytical development, etc.) and support functions (QA, sample management, etc.) </li></ul></div><div><ul><li>Assisting senior group leaders and/or managers in their responsibilities. </li></ul></div><div><ul><li>Preparation and implementing SOPs and company operational policies. Ensuring adherence and making recommendations for quality system improvements. </li></ul></div><div> </div><div>Education and Experience </div><div><ul><li>Min. Degree level education in Relevant scientific field (inc. Chemistry) </li></ul></div><div><ul><li>Min. 5 years relevant experience within an analytical lab environment in a similar position </li></ul></div><div><ul><li>Management experience in pharmaceutical/contract lab environment </li></ul></div><div><ul><li>Strong quality experience – review and approval of quality documentation </li></ul></div><div>Knowledge, Skills, Abilities </div><div><ul><li>Demonstrated proficiency within a lab environment to include HPLC, GC, MS, Dissolution testing, Karl Fischer, UV-vis, FT-IR, TOC.  </li></ul></div><div><ul><li>Proven leadership skills  </li></ul></div><div><ul><li>Ability to train and mentor junior staff  </li></ul></div><div><ul><li>Demonstrated ability to be project solution driven  </li></ul></div><div><ul><li>Good written and oral communication skills as well as presentation skills  </li></ul></div><div><ul><li>Can independently perform root cause analysis for method investigations  </li></ul></div><div><ul><li>Technical writing skills; ability to write quality documents (SOPs, investigation forms, etc.)  </li></ul></div><div><ul><li>Demonstrated knowledge of QA metrics of program base; ability to write and recommend changes to PPD SOPs  </li></ul></div><div><ul><li>Ability to independently optimize analytical methods  </li></ul></div><div><ul><li>Project and time management skills  </li></ul></div></div><div><div>Work Environment </div><div>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: </div><div><ul><li>Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. </li></ul></div><div><ul><li>Able to work upright and stationary and/or standing for typical working hours. </li></ul></div><div><ul><li>Able to lift and move objects up to 25 pounds. </li></ul></div><div><ul><li>Able to work in non-traditional work environments. </li></ul></div><div><ul><li>Able to use and learn standard office equipment and technology with proficiency. </li></ul></div><div><ul><li>May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments. </li></ul></div><div><ul><li>Able to perform successfully under pressure while prioritizing and handling multiple projects or activities. </li></ul></div><div> 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. </div><div>Apply today! <a href="http://jobs.thermofisher.com/" target="_blank">http://jobs.thermofisher.com</a> </div><div>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. </div><div>Accessibility/Disability Access </div><div>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. </div><div>*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. </div><div> </div><div> </div></div>

Group Leader, Pharma

Description

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