Your mission

Process Data Analytics Sr. Manager

At Pierre Fabre Pharmaceuticals Inc. our mission is to deliver breakthrough therapies in oncology and rare diseases to patient populations with high unmet needs and limited treatment options. Our belief is that every time we care for a single person, we make the whole world better.  We are the US pharmaceutical subsidiary of Pierre Fabre Laboratories Worldwide, a foundation-owned company with 7 decades of impact. Pierre Fabre Laboratories is a truly global healthcare company, established in 43 countries, with products distributed in 119 territories across the globe. Pierre Fabre's foundation ownership enhances our ability to focus on creating long-term value for patients.   

Building on the legacy of Pierre Fabre Laboratories, innovation is our life blood and patient experience drives everything we do. We aspire to design and develop therapeutic solutions inspired by patients and healthcare professionals; draw on science and nature as perpetual sources of inspiration; develop long-term partnerships with researchers and innovators worldwide; and place pharmaceutical ethics and climate transition at the heart of our action.  

Pierre Fabre Pharmaceuticals is headquartered in Parsippany, NJ alongside Pierre Fabre USA Inc., a Pierre Fabre Laboratories subsidiary focused on dermatology and cosmetics.  

SUMMARY:

Pierre Fabre Pharmaceuticals is seeking a highly motivated, and well-organized Process Data Analytics Manager or Senior Manager.  This role will be responsible for the collection, aggregation, and analysis of start to end raw material, intermediate, 3PL, process and QC data.  The manager of Process Data Analytics will develop the tools to monitor and analyze the data to support decisions across the enterprise.   

KEY RESPONSIBILITIES:

• Start-up data analytics function at Pierre-Fabre Pharmaceuticals
  • Implement and administer data collection and aggregation system:
    • Take point with software supplier, raw material suppliers, 3PL and CDMOs to coordinate the collection of data and ensure good data integrity practices are implemented/maintained.
    • Manage contractors responsible for manual data entry from batch records.
• Gain a technical understanding of the manufacture and testing of the product.
  • Support Product/Process investigations.
    • Perform statistical analysis to support investigations.
  • Execute continuous process monitoring.
    • Trend process and QC data, proactively identify trends and investigate.
    • Monitor raw material lot changes identify shifts that correspond to those changes.
    • Compare results from multiple sources (i.e two CDMOs) for systemic differences.
• General
  • Develop procedures and work instructions required to perform required tasks.
  • Identity key performance indicators and collaborate with team to drive towards them.
  • Issue routine updates from communication tools or platforms, e.g. monthly dashboards, reports, etc.

REQUIRED EDUCATION AND EXPERIENCE:

• Bachelor's degree and 8-10 years of related biopharmaceutical work experience or Master’s degree and 6-8 years of work experience. 
• Minimum of 2 years of experience in data analytics.
• Exceptional organizational and time management skills; ability to multi-task in fast paced environments.
• Ability to work independently and in a cross-functional team environment.
• Ability to problem solve, lead with courage, and directly address issues.
• Preferred experience in cell and gene therapy.
• Two years’ experience employing strong communication skills clearly and concisely presenting conclusions from data analyses to wide range of stake holders.
• Proficiency in some or all of the following: Microsoft Office, advanced Excel, advanced SQL, R script, JMP/JMP PRO, MiniTab, Smartsheet, Design Expert, SIMCA, Discoverant, Skyland PIMS, Statistica, Pi historian, Tableau, Power BI, and Salesforce
• Proficient in Statistical Process Control, ANOVA (analysis of Variance), Regression analysis, Monte Carlo Simulation, Hypothesis testing, Guage R&R, Capability Analysis, Power/Sample size analysis, Factor analysis, Cluster analysis, Predictive modeling, Statistical Process Control and Experimental Design.

WORK ENVIRONMENT:

• This is a remote position.

Benefits of being a Pierre Fabre Employee

Join Pierre Fabre for competitive benefits including three medical plans, dental and vision coverage, voluntary benefits, a 401(k) plan, and more! Our offerings also include a hybrid work policy, a generous PTO policy and company holidays, paid