Aufgaben
Position Summary:
An experienced biological team lead who enjoys working in a fast-paced environment. The candidate should be able to effectively direct laboratory-based microbiology and biological studies evaluating a variety of medical devices according to ISO 10993, ISO 11135, ISO 11737-1 and ISO 11737-2 as well as FDA Good Laboratory Practices (GLP) regulations. The Team Lead and Study Director will drive continuous improvement initiatives, enhance testing methodologies, and provide cross-functional leadership to ensure the highest technical and quality standards. The ideal candidate has a strong and exhaustive laboratory background, as well as excellent client service, project management, quality system and people leadership skills. As a proactive leader and collaborator, this individual will work closely with laboratory teams, clients, and management to support laboratory operations and meet client needs efficiently and effectively.
This position is an onsite position based in New Brighton, MN.
Responsibilities:
Act as team lead of the New Brighton biological team to enhance testing capabilities, refine laboratory procedures, and establish test recommendations in microbiology and biocompatibility, aligning with the organization’s goals and evolving regulatory requirements.
Assign tasks and set goals for team members, while monitoring team performance and providing feedback.
Facilitate team problem-solving and conflict resolution and report progress to management.
Perform Study Director functions as outlined FDA Good Laboratory Practices (21 CFR Part 58).
Ensure adherence to protocols and amendments, company SOPs, and applicable regulatory requirements through study conduct.
Lead, support, and drive improvements in the laboratory’s quality system, compliance processes, and technical documents, leveraging experience in GLP and ISO standards.
Build and lead a strong team of scientific laboratory analysts to support study and method development while maintaining expected timelines.
Excellent leadership skills.
Lead and support in planning and execution of equipment/instrument installation, qualification, calibration, and validation activities applicable to the biocompatibility and microbiology laboratories, to meet operational and regulatory requirements.
Participation in strategic alignment and development of the business service.
Assure that all data, including unanticipated responses, are accurately recorded, verified, and organized
Utilize strong project management skills to efficiently manage multiple studies and clients.
Collaborate and clearly communicate with cross-functional teams and clients to ensure client's needs are met.
Prepare, approve and report studies in a timely manner in accordance with expected performance metrics.
Training and mentoring scientific laboratory analysts.
Provides leadership and guidance regarding testing/study execution to laboratory analysts and the laboratory support team, including scientific project managers, test facility management, laboratory coordinators, and the quality assurance unit.
Other duties as assigned
The anticipated annual base pay range for this full-time position is $100,000-$110,000. Actual base pay will be determined based on various factors, including years of relevant experience, training, qualifications, and internal equity. The compensation package may also include an annual bonus target, subject to eligibility and other requirements. Additionally, we offer a comprehensive benefits package to employees, including a 401(k) plan with employer match, 12 weeks of paid parental leave, health plans (medical, dental, and vision), life insurance and disability, and generous paid time off.
Qualifikationen
Education and Experience:
Minimum BS/BA in microbiology or related field
Minimum of 4 years of applicable experience in a medical device laboratory environment
At least two years of experience in a study director role in a regulated environment
Minimum of 1-2 years of people management
Knowledge, Skills, and Abilities:
Ability to organize and track multiple projects in a detail-oriented and self-directed manner
Exhibit excellent communication skills and be a proactive, collaborative team player
Strong leadership skills and the ability to influence change
Strong working knowledge of industry regulations (ISO 10993 series of standards, ISO 17025, ISO 13485, ISO 10993, ISO 11135, ISO 11737-1, ISO 11737-2, GMP and GLPs) supporting a medical device environment
Full knowledge in the review, evaluation, interpretation, and implementation of internal and external guidance's (e.g., ISO, GLP/GMP/QSIT)
Ability to organize and track multiple projects in a detail-oriented and self-directed manner
Maintain accurate schedule and follow-up efficiently
Strong organizational skills required
Advanced problem-solving skills and strict attention to detail
Strong technical writing and oral communication skills
Fundamental competencies form the foundation for individual and organizational success in TÜV SÜD and apply to all employees and showcase behaviors aligned to TÜV SÜD values and culture cornerstones and will be evaluated in performance assessments.:
Communication
Collaboration
Customer Orientation
Self Management