Sr. Manager, Stability Cmos

vor 5 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.

We are seeking a highly motivated and experienced Senior Manager Stability CMOs to join our dynamic team in Basel. This pivotal role involves managing direct reports and routine operations of the Drug product and Drug substance CMOs for Commercial GMP stability programs, ensuring compliance with SOPs, policies, and industry guidance. You will be instrumental in leading, facilitating, and supporting global processes for the harmonization and integration of stability-related activities, owning and supporting various GMP Quality Systems.

**Here’s What You’ll Do**:Your key responsibilities will be**:
**Leadership and Management**: You will manage, lead, and support the training of direct reports, set department goals, and compile/communicate performance reviews. Your leadership will inspire the team to foster an environment focused on continuous improvement activities for commercial stability programs.

**Process Harmonization and Integration**: Taking charge of processes for harmonization and integration of stability-related activities, including SOPs, stability protocols, and data integration among sites for global stability products, will be crucial. You will author, review, revise, and approve these documents, ensuring global compliance and consistency.

**Collaboration and Strategy**: Leading, facilitating, and executing stability study protocol strategy and design through direct collaboration with CMO stability specialists. This includes authoring and reviewing supporting memos and reports for expiry, interiM/Final stability reports, and Annual Product Quality Reports.

**Your responsibilities will also include**:
**Quality Systems Management**: You will manage, lead, and own Quality Systems (eQMS) records for QC Stability—creating, assessing, reviewing, and approving deviations, change controls, CAPAs, and other applicable stability-related investigations and events.

**Audit and Inspection Readiness**: Leading and supporting site inspection readiness and audit activities, ensuring the functionality and maintenance of stability-related processes and systems at CMOs.

**Regulatory Submissions and Coordination**: You'll be responsible for authoring and reviewing applicable stability sections of regulatory submissions and coordinating with appropriate lab management teams to ensure the scheduling of stability sample submission, testing, and reporting of data.

**Stability Metrics and Communication**: Facilitating, leading, and supporting all activities for stability team meetings and reporting and communicating stability metrics to the Stability committee and key stakeholders in a timely manner.

**Statistical Analysis and Compliance**: Supporting statistical analysis activities for shelf-life, managing stability schedules for GMP stability drug substance and drug product, and ensuring compliance with cGMP and safety requirements.

**The key Moderna Mindsets you’ll need to succeed in the role**:
**Act with urgency**: This role requires immediate and effective action to impact the lives saved tomorrow.

**Pursue options in parallel**: You will need to evaluate multiple strategies simultaneously to make the best decisions for stability programs.

**Here’s What You’ll Bring to the Table**:
Bachelor’s degree in relevant scientific discipline with a minimum of 8-10 years Quality Control experience in a Commercial/ Quality Assurance/ Quality Control Biotech or Pharma setting with a focus on Stability (preferable in life science or equivalent), including regulatory submissions. Fluent in written and spoken English.

Deep understanding and experience with EU, US and ICH guidelines and regulations.

Experience in managing stability programs and with stability data trending analysis.

Minimum of 2-4 years or more of leadership/management experience including involvement with regulatory audits and inspections.

General experience in data analysis and statistical evaluation and trending of data.

Abili

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