TÜV SÜD
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Biological Team Lead & Study Director
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TÜV SÜD 2 days ago Be among the first 25 applicants Join to apply for the
Biological Team Lead & Study Director
role at
TÜV SÜD Get AI-powered advice on this job and more exclusive features. Established more than 150 years ago in Germany, TÜV SÜD is a leading global provider of technical services with more than 25.000 highly skilled employees across 1,000 offices worldwide. For over 30 years, throughout 33 locations, it is TÜV SÜD America’s priority to create a safer future. To protect people, property and the environment from technology-related risks; we drive consumer protection, digital transformation, sustainable development, and urbanization.
Tasks/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.
Qualifications/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
Further Information
Equal Opportunity Employer Disability and Veteran
TÜV SÜD America, Inc. is an equal opportunity, affirmative action employer and considers qualified applicants for employment without regard to race, color, creed, religion, ancestry, marital status, genetics, national origin, sex, sexual orientation, gender identity and expression, age, physical or mental disability, veteran status and those laws, directives, and regulations of Federal, State, and Local governing bodies or agencies. We participate in the E-Verify Employment Verification Program.
For more information on applicable equal employment regulations, please refer to the following: Seniority level
Seniority level Associate Employment type
Employment type Full-time Job function
Job function Information Technology Industries Public Safety Referrals increase your chances of interviewing at TÜV SÜD by 2x Get notified about new Director Team Lead jobs in
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Biological Team Lead & Study Director
role at
TÜV SÜD 2 days ago Be among the first 25 applicants Join to apply for the
Biological Team Lead & Study Director
role at
TÜV SÜD Get AI-powered advice on this job and more exclusive features. Established more than 150 years ago in Germany, TÜV SÜD is a leading global provider of technical services with more than 25.000 highly skilled employees across 1,000 offices worldwide. For over 30 years, throughout 33 locations, it is TÜV SÜD America’s priority to create a safer future. To protect people, property and the environment from technology-related risks; we drive consumer protection, digital transformation, sustainable development, and urbanization.
Tasks/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.
Qualifications/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
Further Information
Equal Opportunity Employer Disability and Veteran
TÜV SÜD America, Inc. is an equal opportunity, affirmative action employer and considers qualified applicants for employment without regard to race, color, creed, religion, ancestry, marital status, genetics, national origin, sex, sexual orientation, gender identity and expression, age, physical or mental disability, veteran status and those laws, directives, and regulations of Federal, State, and Local governing bodies or agencies. We participate in the E-Verify Employment Verification Program.
For more information on applicable equal employment regulations, please refer to the following: Seniority level
Seniority level Associate Employment type
Employment type Full-time Job function
Job function Information Technology Industries Public Safety Referrals increase your chances of interviewing at TÜV SÜD by 2x Get notified about new Director Team Lead jobs in
New Brighton, MN . Executive Director - $5,000 Hiring Bonus!
Minneapolis, MN $206,000.00-$356,000.00 2 weeks ago Director, Strategic Growth - Health Innovation & Partnerships
Minneapolis, MN $169,700.00-$254,700.00 1 week ago Minneapolis, MN $112,454.00-$140,567.00 3 weeks ago Director and Team Lead, Commercial Policy & Procedures
Minneapolis, MN $137,000.00-$238,000.00 1 week ago Director of Operations - Animal Nutrition
Minneapolis, MN $175,000.00-$250,000.00 1 month ago Operations Management Executive Director
Minneapolis, MN $101,000.00-$152,000.00 2 weeks ago Senior Director-Quality, Analytical Services
Woodbury, MN $182,500.00-$241,650.00 2 days ago Minneapolis, MN $105,000.00-$144,000.00 2 days ago Minneapolis, MN $160,000.00-$175,000.00 3 weeks ago Director of Print Operations - Eagan, MN
St Paul, MN $80,000.00-$120,000.00 5 days ago Minneapolis, MN $125,000.00-$140,000.00 1 month ago Advisory Director, Care Transformation - Remote
Eden Prairie, MN $132,200.00-$226,600.00 37 minutes ago Area Director – Minneapolis and Surrounding
Director of Design - Experiential Strategy & Design
Minneapolis, MN $110,000.00-$130,000.00 3 weeks ago Minneapolis, MN $120,000.00-$140,000.00 3 days ago Director - Head of Mutual Fund and Alternative Investment Operations
Minneapolis, MN $180,000.00-$270,000.00 1 week ago Minneapolis, MN $300,000.00-$350,000.00 1 month ago Hennepin County, MN $191,500.00-$255,000.00 1 month ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr