Full-Time

Sr. Manager

Visual Inspection, Labeling and Packaging Operations

Posted on 9/10/2024

Moderna

Moderna

5,001-10,000 employees

Develops mRNA-based medicines for health

Biotechnology
Healthcare

Senior

Norwood, MA, USA

70% in-office structure.

Category
Healthcare Administration & Support
Medical, Clinical & Veterinary
Requirements
  • Bachelor of Science degree in Engineering, Pharmaceutical Sciences, or a related technology discipline.
  • A minimum of 8 years of experience in drug product inspection, labeling, and packaging, with at least 2 years in a leadership role.
  • Experience working with semi-automated inspection equipment.
  • Experience working with semi-automated labeling and packaging equipment.
  • Proficiency with clinical and commercial labeling requirements including med IDs and serialization.
  • Experience developing Knapp Test Kits and implementing an operator qualification strategy in support of visual inspection.
  • In-depth knowledge of cGMP regulations, pharmaceutical processing, and cleanroom operations.
  • Strong leadership skills with the ability to develop and motivate a diverse team.
  • Excellent project management, organizational, and communication skills.
  • Demonstrated ability to work cross-functionally and manage complex projects with multiple stakeholders, with the ability to convey complex information in an understandable manner to various stakeholders.
  • Experience with budget management and cost optimization in a manufacturing environment.
  • Problem-solving mindset with a commitment to quality and safety.
Responsibilities
  • Develop and execute Operational readiness strategies to ensure the successful launch and ongoing production of drug products.
  • Establish robust operational readiness plans to transition from the construction phase to full-scale production, ensuring all systems and processes are in place for cGMP compliance.
  • Oversee the hiring, training, and development of a high-performing operations team capable of executing visual inspection, labeling, and packaging across multiple production lines.
  • Collaborate with cross-functional teams working in a highly matrixed environment to drive decisions and influence outcomes to enable Moderna’s clinical pipeline.
  • Drive continuous improvement initiatives to enhance operational efficiency, reduce costs, and improve product quality.
  • Develop and manage the operational budget, including capital expenditure planning and cost control measures.
  • Lead risk management activities to identify potential operational issues and implement mitigation strategies.
  • Ensure adherence to all environmental, health, and safety guidelines, promoting a culture of safety within the operations team.
  • Establish key performance indicators (KPIs) to measure and report on operational performance, making data-driven decisions to optimize processes.
  • Foster a culture of innovation and collaboration, encouraging team members to contribute ideas for process improvements and operational excellence.
  • Serve as the primary point of contact for operations during regulatory inspections and audits.

Moderna focuses on developing medicines using messenger RNA (mRNA), which is a crucial component in how cells produce proteins necessary for various biological functions. Their approach involves creating a new class of medicines that utilize mRNA to instruct cells to produce specific proteins, potentially leading to significant advancements in treatment options for patients. Unlike traditional pharmaceuticals, which often rely on small molecules or proteins, Moderna's mRNA-based therapies aim to enhance the discovery, development, and manufacturing processes of medicines. The company's goal is to leverage the unique properties of mRNA to improve patient outcomes and create a new category of effective treatments.

Company Stage

IPO

Total Funding

$5.9B

Headquarters

Cambridge, Massachusetts

Founded

2010

Growth & Insights
Headcount

6 month growth

4%

1 year growth

16%

2 year growth

55%
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Simplify's Take

What believers are saying

  • Opening a new vaccine facility in Victoria enhances manufacturing capabilities.
  • Strategic investment in China boosts Moderna's presence in the Asian market.
  • Collaboration with Carisma Therapeutics could lead to breakthroughs in autoimmune treatments.

What critics are saying

  • Potential removal from Nasdaq 100 could impact investor perception.
  • Reticence in Hong Kong for Covid-19 jab indicates market penetration challenges.
  • Expansion into China may expose Moderna to geopolitical and regulatory risks.

What makes Moderna unique

  • Moderna is pioneering mRNA technology for innovative medical treatments.
  • The company has a strong focus on developing vaccines for infectious diseases.
  • Moderna's mRNA platform enables rapid development of therapeutics and vaccines.

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