Associate Director, Microbiology

vor 4 Monaten

Basel, Schweiz Moderna Vollzeit

The Role
Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives. Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience with the potential to make a significant impact on patients' lives worldwide.
Moderna is solidifying its footprint in Basel, the vibrant hub of pharmaceutical innovation in Switzerland, to further our mission of delivering the greatest possible impact to people through mRNA medicines. As we grow our international operations and commercial activities in Basel, we invite global talents to join us in this exciting journey of transforming medicine and impacting lives worldwide.
In this role, you will oversee QC microbiology activities at contract manufacturing and testing organizations globally, leading QC raw material, drug substance, and finished product testing to ensure compliance with internal policies, procedures, and regulatory requirements. You will provide microbiology expertise, lead the microbiology experts group, and drive improvement initiatives across Moderna’s External QC operations. This role will be critical to ensuring robust quality control processes as Moderna continues integrating automation and digital technology. You will also take charge of microbiology-related issues, deviations, and gap remediation activities.
**Here's What You’ll Do**:Your key responsibilities will be**:
Lead QC microbiology activities at contract manufacturing and testing organizations globally (USA, Europe, Asia), including implementing microbiological testing capabilities, method transfer, validation, and qualification activities.
Provide microbiological expertise to support environmental monitoring programs and manufacturing operations, contributing to microbial control risk assessments, product impact assessments, and changes.
Lead complex investigations and troubleshooting of microbiological methods to support QC operations and ensure timely resolution and escalation.
Review, approve, and implement cGMP documentation (policies/SOPs, microbiological test methods, protocols, etc.).
Lead laboratory investigations related to testing activities, including OOS/OOT, CAPA, Deviation, Gap Remediation, and Change Controls.
Collaborate with Regulatory CMC teams to ensure regulatory commitments are met and timelines are maintained.
**Your responsibilities will also include**:
Perform proactive surveillance of global regulatory requirements.
Lead, coach, and develop a global team of microbiology experts.
Collaborate with Manufacturing, Science and Technology (MS&T), Quality Assurance (QA), Supply Chain, and CMC Teams.
Travel internationally (~15%).
**The key Moderna Mindsets you’ll need to succeed in the role**:
**Prioritize the Platform**: Your ability to focus on the platform over any single product will be vital in driving QC microbiology advancements that support Moderna’s broader mission.
Here’s What You’ll Need ( Basic Qualifications)
Bachelor’s degree in relevant scientific discipline with minimum experience of 10-12 years within the industry and quality control with a focus in microbiology.
2-3 years management/supervisory/lead experience in cGMP organization.
Here’s What You’ll Bring to the Table (Preferred Qualifications)
Working knowledge of relevant EU, FDA and global regulations and ICH, ISPE, ASTM standards/guidelines and experience in participation of regulatory inspections.
Experienced in executing microbiological quality control testing, method transfers and validation within a biotechnology industry.
Experience with rapid microbiology methods (preferred)
Fluency (written / spoken) in English - fluency in other languages is advantageous
A proven track record of success in managing quality control projects with external testing sites in a biopharma organization.
Excellent interpersonal skills using a team-oriented approach to project management and problem solving for complex issue resolution in a scientifically sound and understandable way.
Outstanding communication skills (verbal and written) to all employee levels, executive leadership and external partners, suppliers, third parties, and industry organizations.
Experience working with CMOs, CLOs, vendors, and relationship management preferred
Ability to conceptualize, analyze, plan and manage multiple projects in a fast-paced environment.
Ability to be agile and effectively collaborate in a dynamic, cross-functional matrix environment.
Ability to navigate through ambiguity and rapid growth and adapt to change.
A ‘digital first’ and curious mindset that allows you to constantly learn and challenge the status q

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