Lab Manager/Associate Director, Biopharmaceuticals (GMP Laboratory)

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Role: Lab Manager / Associate Director

Department: Biopharmaceutical

Location: Middleton, Wisconsin

Details: Full time, fully onsite

This is a fully onsite role based at our GMP Laboratory in Middleton, WI. We welcome applicants from all locations within the US. Please note that relocation assistance is not provided for this position, and any relocation costs will be the responsibility of the candidate. Must be legally authorized to work in the United States without sponsorship. Must be able to pass a comprehensive background check, which includes a drug screening. 

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.

A Day in the Life

This role will supervise and assist group leaders, scientists, and other lab members in laboratory operations with tasks such as scheduling, resource management, technical and compliance related issues. This role plans, directs and implements improvements in systems, processes and procedures to increase efficiency, productivity and quality in the laboratory. Additionally, will assist the division director in strategic planning, business development and expansion initiatives by providing mid-range (1-3 month) resource utilization predictions for a department.

Essential Functions:

• Interact with clients and business development on requests for proposals and project definition. Prepare, review and approve bids and proposals, scope of work and pricing. Negotiate with clients on timelines and pricing.

• Manage/direct work responsibilities of group leaders as well as prioritize talks and resources.

• Review data for technical quality and compliance to protocols, methods and SOPs. Review and approves laboratory investigation, deviations, and QA facility and data audits. Lead client and regulatory audits.

• Prepare and update revenue projection reports, review Partner and timesheet reports for revenue recognition and billing, evaluate resource utilization reports and project profitability.

• Review and approve study protocols, project status reports, final study reports and other project related technical documentation.

• Assist in technical sales and marketing, prepare technical marketing materials, and participate in poster and podium presentations in technical conferences.

• Assist upper management in strategic planning, budgeting, new capabilities development and other responsibilities.

• Prepare and implement SOPs and company operational policies. Ensure adherence and makes recommendations to quality system improvements.

Keys to Success

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 10+ years) or equivalent and relevant combination of education, training, & experience.

• 5+ years of management responsibility

• Proven leadership skills

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:

• Full understanding of laboratory requirements, PPD and client SOPs, ICH guidelines, USP requirements and FDA guidance

• Proven technical troubleshooting analytical instrumentation and problem solving abilities

• Excellent written and oral communication skills

• Project and time management skills

• Ability to implement quality systems and process improvements

• Ability to provide guidance to clients on analytical issues and regulatory requirements

• Knowledge of budgeting, forecasting and fiscal management

• Demonstrated coaching and mentoring skills

• Demonstrated strategic planning skills

• Strong organizational agility and demonstrated drive for results.

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 prioritizing and handling multiple projects or activities.

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. As 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 with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

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.

*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.