Full-Time

Empt Lead

Posted on 11/16/2024

Sanofi

Sanofi

10,001+ employees

Develops pharmaceuticals and life-saving vaccines

Biotechnology
Healthcare

Senior, Expert

Cambridge, MA, USA + 3 more

More locations: Bridgewater Township, NJ, USA | Framingham, MA, USA | Westborough, MA, USA

Onsite presence required.

Category
Healthcare Administration & Support
Medical, Clinical & Veterinary
Requirements
  • Hands on experience in manufacturing operational roles, ideally as quality assurance manager for drug product manufacturing.
  • Working knowledge of Technical Transfers and Commercial readiness
  • Working knowledge of the design and implementation of a Quality Management System
  • Working knowledge of preparing a site for regulatory inspections
  • Working knowledge of complex distribution and supply chain network- e.g. Cell Therapy or just in time manufacturing and supply.
  • Good exposure to cross sites & cross GBUs networking.
  • Knowledge or experience working with Radio Ligand Therapies would be preferable.
  • Basic or good understanding of data management and IA digital products
  • Knowledgeable in E2E product & industrial strategy, performance management, project management
  • Knowledgeable in biotech/pharmaceutical industry technologies
  • Strong analytical skills.
  • Good command of KPI target setting & monitoring
  • Bachelor’s degree with scientific background or equivalent and 10+ years of experience OR Master’s degree with scientific background or equivalent and 8+ years of experience
  • Fluent English
Responsibilities
  • Accountable for on time and in full delivery of products for CMOs/External Suppliers within EMPT unit, accountable for tracking of EST KPIs. Drives continuous improvement in the performance of the supplier in areas of Safety, Quality, Cost & Delivery
  • Develops and maintains a positive culture to create the right environment for highly productive teams in a psychologically safe environment.
  • Accountable for management of the products/ CMOs from an operational & financial perspective, management of related activities against contract guidelines (MSA & QTA) and responsible for routine technical support.
  • Build and facilitate collaborative business relationships with external partners/suppliers (CMO, CLO, Material Suppliers) & internal business partners (GSC, MSAT, Legal etc)
  • Serve as the first level negotiation on financial liability for failed or rejected lots in collaboration with procurement.
  • Plan & implement life cycle management projects, including resource and financial planning, in collaboration with business partners.
  • Accountable for execution of CMO Management processes ensuring standard governance meetings are routinely held, decisions and actions are documented, and the correct attendees participate. Facilitate internal stakeholder alignment prior to joint governance meetings.
  • Key member of the Industrial Product Teams and Technical Product Team representing the EMPT.
  • Accountable for adherence to the Risk Management Program and proactively identifies, evaluates, documents, and communicates risks potentially impacting quality, compliance, and supply. Participates in multi-disciplinary teams to define remediation plans to mitigate risks impacting products and GxP operations.
  • In collaboration with Supply Chain ensures routine monitoring of CMO inventories, assessing potential risks and providing proactive remediation plans.
  • Ensure Compliance through active participation at all applicable quality governance forums. Accountable for on time delivery of Quality System related records.
  • Accountable as Operational SME for CMO/External Suppliers within EMPT unit, and able to identify and involve the appropriate Technical SMEs to ensure process changes are vetted within Sanofi to determine acceptability and impact to Sanofi manufacturing and quality processes.
  • Accountable for execution of CMO projects in conjunction with CMO organization and applicable EM&S business partners.

Sanofi provides healthcare solutions through its pharmaceutical and biotechnology products, focusing on treatments and vaccines for various medical conditions. The company conducts extensive research and development to create new therapies and improve existing ones, particularly in areas like immunology, oncology, and rare diseases. Sanofi's products include prescription medicines, over-the-counter items, and vaccines, which are distributed to patients, healthcare professionals, and governments. What sets Sanofi apart from its competitors is its strong emphasis on scientific innovation and strategic partnerships, allowing it to maintain a diverse product pipeline and a global presence. The company's goal is to enhance health outcomes and improve the quality of life for individuals worldwide.

Company Stage

Grant

Total Funding

$2B

Headquarters

Paris, France

Founded

N/A

Growth & Insights
Headcount

6 month growth

0%

1 year growth

0%

2 year growth

0%
Simplify Jobs

Simplify's Take

What believers are saying

  • Sanofi's strong financial performance, as evidenced by its raised 2024 outlook, indicates robust growth and stability.
  • The company's strategic investments in innovative biotech firms, such as Ventyx Biosciences, enhance its pipeline and potential for breakthrough therapies.
  • Sanofi's Dupixent receiving a positive recommendation for expanded use in children demonstrates its leadership in addressing unmet medical needs.

What critics are saying

  • The highly competitive pharmaceutical market requires Sanofi to continuously innovate to maintain its market position.
  • Regulatory challenges in different regions could delay product approvals and impact revenue streams.

What makes Sanofi unique

  • Sanofi's extensive R&D efforts and strategic partnerships, such as with Orano Med for radioligand therapies, set it apart in the competitive pharmaceutical landscape.
  • The company's global reach and focus on patient-centric solutions allow it to effectively navigate diverse regulatory environments and deliver innovative treatments worldwide.
  • Sanofi's investment in sustainable initiatives, like SureChill's 'Cooling as a Service' model, highlights its commitment to addressing healthcare challenges in emerging markets.

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