Director Microbiology DPD

Remote (United States)

When you’re part of Thermo Fisher Scientific, you’ll do important work, and join a team that values performance, quality and innovation! As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create significant contributions to the world.

The DPD Microbiologist is accountable for establishing and maintaining robust industry leading microbiological practices and oversight throughout the drug product (DPD) manufacturing network, establishing, and then leading a global community of practice via a matrix structure.

Responsibilities:

Set and ensure implementation of global procedures, and practices to ensure exceptional performance across the sterile and non-sterile drug product manufacturing sites
Monitor industry regulations and trends to ensure quality control programs are current and best in class
Act as the global authority for microbiology topics.
Install trending program for environmental monitoring programs across sterile sites and conduct quarterly reviews of data.
Champion the adoption of rapid microbiological methods appropriate to the business needs across DPD
Identify changing regulatory requirements impacting microbiology, own the implementation and ensure appropriate remediation actions are taken. Coordinate the communicated to global leaders.
Establish, own, and lead a global community of practice, using the community to align and standardize microbiology best practices.
Implement a program to mentor, coach, train, and develop existing site-based microbiology leads, and identify talent (external/internal) for importation into the program
Establish a program of periodic audits of the site based microbiology processes such that processes are assessed for compliance to internal and external standards, that areas for improvement are identified in a timely manner, and real time coaching is provided to staff and risks appropriately raised.
Develop a governance program to facilitate appropriate & timely handling of significant issues to senior quality management.
De-risk microbiology practices by implementing risk identification and risk reduction programs using industry trends and adopting risk reducing technologies.
Provide SME support to sites undertaking business critical investigations (i.e., related NSEs, Adverse EM trends, media fill failures, etc.), during key audits, and during major capital projects.
Advocate ThermoFisher’s interests by participating with industry bodies shaping future microbiology guidance and influence outcome.
Partner with strategic clients to ensure the microbiology programs remains as good, or better, than our clients.
Ensure alignment with the business to embed core microbiology principles into new expansions

Internal communication

Divisional and business unit management (Quality, Operations)
With the site and regional Quality Directors (DPD).
With site leadership teams and key site personnel.
Must be comfortable dealing with strong management teams and able to positively influence when required.

External communication

Able to professionally represent the company with key industry bodies and where required clients.

Minimum Requirements/Qualifications:

Minimum BSc in Microbiology, preferably an advanced degree.
Substantial experience, minimum 10 years’ is a senior position and working directly with manufacturing sites, preferably sterile or biologic dosage forms. This position requires deep understanding of drug product microbiological quality control practices. This knowledge needs to be combined with quality risk management principles.
Thorough understanding of US and EU GMPs related to microbiological quality control.
Strong up to date working knowledge of the industry best practice related to microbiological quality control
Can operate as a subject matter expert on regulations pertaining to microbiological quality control.
The role may involve travel (up to 25%).

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 at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

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.

Compensation and Benefits

The salary range estimated for this position based in North Carolina is $145,500.00–$218,250.00.This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

A choice of national medical and dental plans, and a national vision plan, including health incentive programs
Employee assistance and family support programs, including commuter benefits and tuition reimbursement
At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

COVID-19 Vaccination Update for U.S. & Canada Colleagues

All U.S. colleagues are required to disclose their COVID-19 vaccination status. New hires will be asked to disclose their vaccination status upon the first day of employment.
U.S. new hires (including those in Field Sales, Field Services and Customer Support - Technical Applications) may be required to be vaccinated against COVID-19, including boosters, based on the customer or client sites they visit and support. Individuals may also be required to comply with other COVID-19 health and safety protocols, such as masking or testing.
U.S. and Canada new hires in Clinical Research who are in the following job categories must be fully vaccinated before their first day of employment or request an accommodation: executive director level and above, client-facing commercial, clinical research associates (CRAs), Assistant CRA (ACRAs), all CRA and ACRA line managers, clinic-based staff in early development services and accelerated enrollment solutions, and FSP within analytical services division roles.
Canada new hires (including those in Field Sales, Field Services, and Customer Support Technical Applications) may be required to be vaccinated against COVID-19, including boosters, based on the customer or client sites they visit and support. Individuals may also be required to comply with other COVID-19 health and safety protocols, such as masking or testing. New hires in Field Sales, Field Services, and Customer Support Technical Applications will be asked to disclose their vaccination status upon the first day of employment.