Work Schedule
Standard (Mon-Fri)
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.), Strong Odors (chemical, lubricants, biological products etc.), Will work with hazardous/toxic materials
Job Description
Group Leader – Morning Shift, 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.
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 Group Leader – Morning Shift 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, coordinating daily operations to supervise 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 team of analysts
* Allocation, scheduling and leading laboratory resources for group's project activities and updates LIMS for project status. Reviews timesheet reports for billing accuracy.
* Preparation, review and approval of study protocols, project status reports, final study reports and other project-related technical documents.
* Designing experimental study and participates in technical troubleshooting.
* Reviewing data for technical quality and compliance to protocols, methods and SOPs. Review and approve laboratory investigations, deviations, QA facility and data audits. Assists in client and regulatory authority audits.
* Responding to client questions and needs; leads client technical meetings.
* Assisting in preparation of proposals, project definition and pricing.
* Coordinating and prioritising project activities with internal functional groups (physical testing, analytical development, etc.) and support functions (QA, sample management, etc.)
* Assisting senior group leaders and/or managers in their responsibilities.
* Preparation and implementing SOPs and company operational policies. Ensuring adherence and making recommendations for quality system improvements.
Education and Experience
* Educated to a bachelor's degree level in a relevant area, ie chemistry, biochemistry
* Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years) or equivalent and relevant combination of education, training, & experience.
* 1+ year of leadership 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.
* 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, HPLC, UPLC, Electrophoresis (CE, iCE, SDS-PAGE), ELISA, spectrophotometry.
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 prioritising and handling multiple projects or activities.
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.
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