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Associate Group Leader - Biopharmaceutical (GMP) - Middleton Wisconsin
Company: Thermo Fisher Scientific
Location: Middleton, Wisconsin
Posted On: 01/24/2025
Work ScheduleStandard (Mon-Fri)Environmental ConditionsAdherence 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.)Job Description Job Description Role: Associate Group LeaderDepartment: BiopharmaceuticalDetails: Full time, fully onsiteAt 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. Discover Impactful Work: In the Associate Group Leader role, you will manage and coordinate resources and work schedules for laboratory activities, ensuring smooth daily operations. You will assist in the preparation and implementation of company policies, quality systems, and training programs. Your responsibilities will include ensuring timely project completion to meet company revenue targets and client satisfaction with the quality and turnaround time of the work performed. Additionally, you will focus on the continuous development of laboratory staff to align with departmental goals and support growth. A Day in the Life: - Oversee analysts and lab activities for a routine testing and stability team within the Biopharmaceutical department.
- Prepares study protocols, project status reports, final study reports and other project-related technical documentation.
- Designs experimental study and participates in technical troubleshooting.
- Provide regular support and performance management for direct reports, including tracking progress against goals, approving time sheets, and conducting regular meetings.
- Collaborate effectively with other lab leaders to build and maintain strong working relationships.
- Reviews, interprets and analyzes data for technical quality and compliance to protocols, methods and SOPs. Reviews laboratory investigations and deviation.
- Organizes, schedules and supervises laboratory resources for group's project activities and updates project status.
- Responds to client questions and needs, coordinates client communication and records meeting minutes.
- Assists group leaders in their responsibilities.
- Assists in preparation and implementation of PPD/client SOPs and company operational policies. Ensures adherence to SOPs, safety standards and company policies. Keys to Success: Education and Experience:
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 6+ years) or equivalent and relevant combination of education, training, & experience.
- 1+ year of leadership responsibility 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. Knowledge, Skills, Abilities
- Knowledge of biopharmaceutical testing or HPLC preferred
- Knowledge of Good Manufacturing Practices (GMP) preferred
- Demonstrated proficiency on technical operating systems
- Proven leadership skills
- Ability to train and mentor junior staff
- Demonstrated ability to be project solution driven
- Good written and oral communication skills as well as presentation skills
- Can independently perform root cause analysis for method investigations
- Technical writing skills; ability to write quality documents (SOPs, investigation forms, etc.)
- Demonstrated knowledge of QA metrics of program base; ability to write and recommend changes to PPD SOPs
- Ability to independently optimize analytical methods
- Project and time leadership skills 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:
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