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Associate Director, Sterility Assurance, Drug

3 months ago

Norwood, United States Moderna Full time

The Role
Reporting to the Sr. Director of Sterility Assurance, the Associate Director of Sterility Assurance is tasked with leading the development and management of an aseptic and sterility assurance program for a state-of-the-art Drug Product (Fill Finish) cGMP manufacturing facility. This role encompasses overseeing operational readiness for clinical and commercial production, adherence to GxP, corporate, regulatory, and industry standards, and providing cross-functional support for facility start-up activities including Commissioning, Qualification & Validation (CQV).

The Associate Director will play a crucial role in establishing a best-in-class Sterility Assurance program, implementing best practices, and building a team to achieve excellence in manufacturing operations while adhering to regulatory compliance and quality standards. You will be at the forefront of our mission to deliver mRNA therapies to patients worldwide, using your expertise to ensure the smooth operation of our manufacturing processes. Your work will directly contribute to the production of therapies that have the potential to transform the lives of patients.

Here’s What You’ll Do

Collaborate with Moderna’s global and site Sterility Assurance network to drive standardization, harmonization, and best practices across sterile manufacturing operations.

Oversee sterility assurance for drug product operations post-facility start-up, ensuring compliance with cGMPs, company procedures, and regulatory requirements utilizing QBD and contamination control risk assessments.

Establish operational strategies, implement best practices, and lead a team to ensure excellence in manufacturing operations and regulatory compliance.

Support sterile manufacturing site operations by providing expertise in aseptic processing and behaviors, training development, and guidance in sterility assurance.

Drive continuous improvement of aseptic techniques and practices to maintain product sterility.

Provide input for the design of critical utilities and controlled environments and cleanliness control strategies.

Provide input for the design of bioburden-controlled manufacturing processes and sterile fill/finish and packaging technologies, including container-closure integrity and visual inspection.

Lead the design and execution of environmental monitoring programs.

Manage CAPAs, and support regulatory inspections and audits.

Monitor regulatory trends in sterility assurance, adapting strategies as needed.

Develop and manage budget for sterility assurance and environmental monitoring functions, ensuring resource efficiency.

Here’s What You’ll Bring to the Table

Bachelor's degree in Microbiology, Biology, Pharmacy, or related field; advanced degree (MS or PhD) preferred.

At least 10 years’ experience in the pharmaceutical or biotech industry, focusing on sterility assurance, aseptic processing, and environmental monitoring.

Strong knowledge of cGMP regulations, ISO standards, USP and, and other relevant guidance documents.

Experience participating in inspections as a Microbiological Subject Matter Expert (SME) and direct interactions with world-wide Health Authorities with diverse global authority (e.g. FDA, MHRA, EMA, PMDA, ANVISA)

In depth knowledge and expertise in aseptic processing and sterile operations including syringe/vial filling isolators and manual filling.

Expertise in design, qualification and control of clean facilities and critical utilities.

Experience in data analysis and statistical evaluation and trending of microbiological data.

Experience in sterility assurance validation (terminal, aseptic, and/or reprocessing) and environmental controls for pharmaceutical manufacturing facilities.

Competency in multiple industrial terminal sterilization methods (e.g., EO, gamma, electron beam, moist heat, dry heat).

Experience with conducting technical/risk assessments of in-house and contract sterilization processes or contract microbiological laboratories (preferred). Expertise in investigations/deviation management including, writing, and evaluating microbiological OOS’s and laboratory investigations and manufacturing investigations.

Prior experience with authoring and reviewing of Quality-owned regulatory filing sections.

Strong knowledge in microbiological analytical method lifecycle (including rapid microbiology methods preferred).

Capability to lead, educate, train, and develop a diverse, multinational community of practice with multiple stakeholders, working in a supervisory, coaching, mentoring and/or influencing capacity.

Ability to think critically and demonstrate troubleshooting and problem-solving skills. Excellent ability to communicate issues in a scientifically sound and understandable way.

Excellent project management and organizational skills.

Ability to navigate through ambiguity and rapid growth and adapt to change.

Proven ability to manage complex projects and engage cross-functional teams.

Ex