Switzerland Job Openings
Moderna
Associate Director, Microbiology - External Quality Control
Basel
PART TIME
September 9, 2024
Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through m RNA 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 m RNA 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 m RNA 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 c GMP 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.
Collaborate with contract facility personnel and internal subject matter experts to resolve QC testing issues.
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.
Question Convention: You will challenge the status quo by applying innovative solutions to overcome complex microbiological quality control challenges.
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 c GMP 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 quo.
A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.
We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:
Quality healthcare and insurance benefits
Lifestyle Spending Accounts to create your own pathway to well-being
Free premium access to fitness, nutrition, and mindfulness classes
Family planning and adoption benefits
Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary year-end shutdown
Educational resources
Savings and investments
Location-specific perks and extras!
The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.
About Moderna
Since our founding in 2010, we have aspired to build the leading m RNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.
By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.
As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.
If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.
Moderna is committed to offering reasonable accommodations or adjustments to qualified job applicants with disabilities. Any applicant requiring an accommodation or adjustment in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should
contact the Accommodations and Adjustments team at leavesandaccommodations@modernatx.com .
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