Global QC Microbiology: Associate Director

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

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