Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
Job Description
Supervisor, Biopharma
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.
We have an opportunity within our Analytical GMP labs facility and analytical testing on drug substances and products.
Provides line-level management coordination of resources and work schedules. Oversees daily operations and assists in preparation and implementation of company policies, quality systems and training programs. Ensures that projects are completed in a timely manner so that company revenues are met, and clients are satisfied with the quality and turnaround time of work being performed. Ensures that staff continue to be developed to keep pace with department goals and growth.
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Supervises the daily activities of analysts within the Biopharmaceutical team, including interviewing, selection, hiring, professional development, performance management, and reviews and approves time records, requests for leave, and overtime.
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Manages daily workflow, allocates resources, and tracks performance metrics.
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Identifies and recommends process improvements and efficiency gains to optimize processes.
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Monitors and ensures compliance with quality standards, investigates and resolves complex problems through root cause analysis, and implements corrective actions.
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Responds to facility audit findings.
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Assists management in their responsibilities.
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Assists in preparation and implementation of PPD/client SOPs and company operational policies. Ensures adherence to SOPs, safety standards and company policies
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 5+ years) or equivalent and relevant combination of education, training, & experience.
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Demonstrated proficiency of good organizational skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging deadlines.
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Proven leadership skills of technical staff
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Ability to train and mentor junior staff
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Demonstrated ability to be project solution driven
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Good written and oral communication skills as well as presentation skills
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Can independently perform root cause analysis
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Technical writing skills; ability to write quality documents (SOPs, investigation forms, etc.)
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Demonstrated knowledge of QA metrics of program base; ability to write and recommend changes to PPD SOPs
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Project and time management skills
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Full understanding of GMP requirements, client SOPs, ICH guidelines, EP and USP requirements, EMA and FDA guidance's.
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Knowledge and experience of a wide range of techniques, HPLC, UPLC, Electrophoresis (CE, iCE, SDS-PAGE), ELISA, spectrophotometry.
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Work is performed in an office and/or a laboratory and/or with exposure to electrical equipment.
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Exposure to biological fluids with potential exposure to infectious organisms. Rare exposure to skin and lung irritants, radiation, toxic materials and hazardous waste.
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Personal protective equipment required such as protective eyewear, garments and gloves.
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Exposure to fluctuating and/or extreme temperatures on rare occasions.
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Frequently stationary for 6-8 hours per day.
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Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
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Occasional mobility required.
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Occasional crouching, stooping, bending and twisting of upper body and neck.
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Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
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Ability to communicate moderately complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
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Frequently interacts with others, relates sensitive information to diverse groups.
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Ability to apply basic principles to solve conceptual issues.
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Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
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Regular and consistent attendance.
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. A 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 at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
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.
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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