Work Schedule
Other
Environmental Conditions
Office
Job Description
Senior Group Leader -Biopharma
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.
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.
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Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
Location/Division Specific Information
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.
Discover Impactful Work:
The role of Senior Group Leader is to provide support to our Biopharma department by providing management and direction to a group of laboratory staff and resources for project activities and needs, overseeing daily operations to monitor quality and project timeliness, and assist in preparation and implementation of company policies, quality systems and training programs.
A day in the Life
- Management of a tiered organizational structure comprised of supervisors and analysts
- Allocation, scheduling and managing laboratory resources for group's project activities and updates LIMS for project status. Reviews timesheet reports for billing accuracy.
- Review and approval of study protocols, project status reports, final study reports and other project-related technical documents.
- Reviewing data for technical quality and compliance to protocols, methods and SOPs. Approve laboratory investigations, deviations, QA facility and data audits. Leads client and regulatory authority audits.
- Responding to client 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 clients on timelines and budgets.
- Preparing and implementing SOPs and company operational policies Ensuring adherence and making recommendations for quality system improvements.
- Collaborates with business development as technical representative for client visits/discussions. Identifies business opportunities through client interactions, within community, at conferences/workshops. Participates in technical sales and marketing.
- Participates in bi-annual SOP review and change management. Ownership of changes needed to comply with SOPs.
- Regularly communicates to staff quality related issues and items for staff development, and implements quality improvements.
Education and Experience
- Educated to a bachelor's degree level in a relevant area, ie chemistry, biochemistry
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.
- 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.
- 2+ years of management responsibility
Knowledge, Skills, Abilities
- Management experience in the pharmaceutical, biotech or analytical contract laboratory industries
- Stability/QC/analytical R&D/project and program management
- Direct supervision of technical staff, including mentoring/coaching
- Ability to cultivate a collaborative work environment with a team and across business units; including the ability to identify and implement common efficiencies across the teams/units, as well as projects/programs
- Full understanding of GMP requirements, client SOPs, ICH guidelines, EP and USP requirements, EMA and FDA guidance's.
- Knowledge and experience of a wide range of techniques, such as HPLC, UPLC, Electrophoresis (CE, iCE, SDS-PAGE), ELISA, spectrophotometry.
- Understanding of basic financial terms and definitions as it applies to the business
- Ability to independently develop project proposals/plans. Utilizes expertise of others to develop programs to meet client needs.
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 15-20 pounds.
- Able to work in non-traditional work environments.
- Frequently interacts with others, relates sensitive information to diverse groups
- 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.
We welcome and encourage applicants from outside of Ireland. We can provide support with immigration and visa needs for successful applicants and dependents, tax consultations and other basic destination services. All other relocation costs are at the expense of the applicant.