Assoc Director - Molecular Lab - CLIA

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

Summarized Purpose:Supervises and assists group leaders, scientists, and medical technologists in laboratory operations with tasks such as scheduling, resource management, technical and compliance related issues. Plans, directs and implements improvements in systems, processes and procedures to increase efficiency, productivity and quality in the laboratory. Assists the division director in strategy, business development and expansion initiatives by providing mid-range (1-3 month) resource utilization predictions for a department.Essential Functions

• Interacts with clients and business development on requests for proposals and project definition. Prepares, reviews and approves bids and proposals, scope of work and pricing. Negotiates with clients on timelines and pricing.  

• Manages/directs work responsibilities of group leaders as well as prioritize talks and resources.  

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

• Prepares and updates revenue projection reports, reviews Partner and timesheet reports for revenue recognition and billing, evaluates resource utilization reports and project profitability.  

• Reviews and approves study protocols, project status reports, final study reports and other project related technical documentation.  

• Assists in technical sales and marketing, prepares technical marketing materials, and participates in poster and podium presentations in technical conferences.  

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

• Prepares and implements PPD SOPs and company operational policies. Ensures adherence and makes recommendations to quality system improvements.

Minimum Qualifications - Education and Experience:

• 2+ years of management responsibility demonstrating leadership skills AND one of the following:

• Bachelor's degree or Medical Technologist Certification AND 10+ years of previous experience that provides the knowledge, skills, and abilities to perform the job or equivalent and relevant combination of education, training, & experience.  

• OR PhD AND 5+ years of previous experience that provides the knowledge, skills, and abilities to perform the job or equivalent and relevant combination of education, training, & experience.

Preferred Qualifications:

• CAP/CLIA clinical lab experience

• Clinical Genetic Molecular Biologist Scientist (CGMBS) Certification

• Next-Generation Sequencing and Cytogenetics experience

Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.

Knowledge, Skills and 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.