Associate Director, Global QC Microbiology

Socket.dev; Gaithersburg (MD); On-site; USD 146,000 - 234,000; Full time

Benefits offered by this job

Medical, Dental and Vision Insurance

401(K) Plan with Company Match

Parental and Childbirth Leave

Sitterstream: Virtual Tutoring & Child

Tuition Reimbursement

Job summary

BioNTech US in Gaithersburg is seeking an Associate Director, Global QC Microbiology to lead contamination control and sterility assurance across GMP production platforms. You will collaborate with internal teams and external partners to uphold quality, regulatory standards, and patient safety.

The role requires 7–10 years in QC microbiology, GMP experience, and leadership skills. You will oversee QC activities at CDMOs and internal labs, develop global SOPs, and drive microbiology systems like

Qualifications

• 7–10 years in QC microbiology within pharma.
• GMP and CMC development experience, including commercialization.
• Experience managing QC labs or CDMO partners and regulatory interfaces.

Responsibilities

• Lead Contamination Control Strategy and Sterility Assurance across GMP platforms.
• Support auditing activities and risk analysis for patient safety and regulatory compliance.
• Oversee QC activities at CDMOs/external labs; approve SOPs within responsibility.
• Review and approve QC documents (specifications, validation reports, investigations).
• Author global SOPs/standards and implement microbiology systems (LIMS, eQMS).

Skills

Leadership

Communication skills

GMP experience

Regulatory interface

Analytical background

QC labs management

Education

Bachelor's or higher in life sciences

Tools

LIMS

eQMS

Job description

Associate Director, Global QC Microbiology

Gaithersburg, US | full time | Unlimited | Job ID: 11754

About the Role:

At BioNTech, we are committed to revolutionizing medicine by translating cutting-edge science into survival. As a Global QC Microbiology Specialist, you will play a pivotal role in ensuring patient safety and regulatory compliance across our GMP production platforms. Your expertise will contribute to optimizing contamination control strategies and sterility assurance, directly impacting the quality of our products and advancing our mission to address diseases with high medical needs.

In this role, you'll collaborate closely with internal teams and external partners to uphold the highest standards in microbiology and quality control. You'll be part of a dynamic environment that fosters innovation and supports your professional growth while contributing to groundbreaking advancements in medicine.

Your Contribution:

Lead implementation and optimization of sustainable Contamination Control Strategy and Sterility Assurance across all GMP production platforms, internally and externally.

• Support of auditing activities and risk analysis to ensure patient safety and regulatory compliance.
• Oversight for QC activities at CDMOs and external laboratories, including the approval of standard operating procedures within the field of responsibility.

Oversee QC activities of BioNTech internal microbiology labs, CDMOs / MNPs or external laboratories in line with relevant Quality Agreements such as:

• Monitoring and evaluation of relevant release testing results of batches produced by CDMOs
• Ensuring that the QC certification of batches and documents complies with regulatory requirements
• Review and approval of QC-relevant documents (e.g., specifications, analytical validation protocols and reports, investigation reports, stability documentation)
• Authoring of global SOP/standards.
• Implementing strategy regarding microbiology related systems, e.g., LIMS, eQMS, equipment, etc.

A Good Match:

• University degree in a scientific/life-science-related field, Advanced degree desirable
• Minimum of 7-10 years of experience in QC (primarily in Microbiology) within the pharmaceutical industry
• Profound experience in GMP and CMC development, including commercialization
• Experience in managing QC labs/CDMO partners
• Regulatory body interface
• Solid analytical background, experience in clean room qualification
• Previous experience in a leadership function, disciplinary or technical, desirable
• Strong communication skills
• Fluent English (both oral and written) necessaryership experience (disciplinary or technical) is desirable

Your benefits and remuneration:

Expected Pay Range: $146,300/year to $234,100/year + benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance). Compensation for the role will depend on several factors, including responsibilities of the job, education, experience, knowledge, skills, and abilities

BioNTech US is committed to employee wellbeing and offers best-in-class benefits & HR programs to support an inclusive & diverse workforce. Salaried/Position-Targeted Hourly Employees working 30+ hours per week are eligible for our comprehensive benefits package. Benefits include but are not limited to:

• Medical, Dental and Vision Insurance
• Life, AD&D, Critical Illness Insurance
• Pre-tax HSA & FSA, DCRA Spending Accounts
• Employee Assistance & Concierge Program (EAP) available 24/7
• Parental and Childbirth Leave & Family Planning Assistance
• Sitterstream: Virtual Tutoring & Childcare Membership
• Paid Time Off: Vacation, Sick, Bereavement, Holidays (including Floating) & Year-End U.S. Shutdown.
• 401(K) Plan with Company Match
• Tuition Reimbursement & Student Loan Assistance Programs
• Wellbeing Incentive Platforms & Incentives
• Professional Development Programs
• Commuting Allowance and subsidized parking
• Discounted Home, Auto & Pet Insurance

…and more! More details to be shared.

Located in the BioHealth Capital Region near Washington DC and ranked among the top biopharma hubs in the country, Gaithersburg, Maryland offers a unique and diverse cluster across industry, government, and academia for top talent and scientific innovation. As a pivotal player within the life sciences community, Gaithersburg is distinguished by its robust infrastructure and strategic location near the nation’s capital. The city’s strategic significance is amplified by its state-of-the-art manufacturing facilities that cater to the rigorous demands of the life sciences industry; Gaithersburg’s manufacturing sector is defined by advanced technologies and complies with the most stringent regulatory standards, ensuring the production of high-quality pharmaceuticals, biologics, and medical devices. In the coming years, Gaithersburg will continue to be a vital contributor to the future of medical science and technology.

By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider 'HireRight'. You will be informed accordingly by your BioNTech-Recruiter.