Supervisor, QC Analytical In-Process

6 days ago

Novato, California, United States BioMarin Pharmaceutical Full time
Job Summary

BioMarin Pharmaceutical is seeking a highly skilled and experienced Quality Control Analytical Supervisor to join our team. As a key member of our Technical Operations group, you will be responsible for supervising the biological, biochemical, and chemical evaluation of in-process, drug substance, studies, and investigational samples in support of the manufacturing process of commercial and clinical drug products.

Key Responsibilities
  • Supervise the QCA team while embodying the principles of the BioMarin Leadership model
  • Interview and hire potential candidates to fulfill business needs
  • Motivate and retain talented individuals within the QCA Department
  • Manage and develop the performance of direct reports by setting clear performance goals, providing timely performance feedback, recognizing and rewarding high achievers, and holding reports accountable for underperformance
  • Timely address discipline and performance issues
  • Ensure execution of QCA laboratory activities in strict accordance with Standard Operation Procedures, GMP, and Regulatory requirements
  • Schedule and/or deliver training to QCA personnel in accordance with Department Training Plan to ensure staff can perform assigned tasks correctly, safely, and compliantly
  • Assign tasks, create and update laboratory schedule
  • Supervise operations in the QCA Lab during the applicable shift
  • Represent the functional area in meetings and compliance activities
  • Analyze In-Process data and generate trending/product review reports
  • Review and audit documentation to ensure accuracy, specifications, and GMP compliance
  • Coordinate and oversee laboratory testing execution to produce results in a timely manner without compromising quality
  • Review SOPs, coordinate method development, and ensures concurrency with cGMP regulations and requirements
  • Maintain and control laboratory inventories
  • Maintain positive relationships and network effectively across sites and organizations
  • Validate methods and laboratory equipment and write procedures
  • Provide laboratory support for inspection readiness
  • Work with Project Teams to drive timelines and efforts to the common goal
  • Ensures compliance with 21 CFR, USP, EP, and ICH regulatory guidelines
Requirements
  • B.S. degree in a biological or biochemical science and at least 4 years of experience in a pharmaceutical laboratory (at least 2 years in QC) that includes some supervisory experience
  • M.S. degree with at least 2 years of GMP laboratory experience
  • Exceptional People Leadership, including motivates, inspires, builds, and retains highly effective laboratory teams while managing for high performance and developing others
  • Versatile learner and courageous decision maker
  • Effectively operate in an evolving complex and dynamic environment
  • Provides clear direction and instruction to direct reports
  • Continuously looking internally and externally for best practices and areas for improvement
  • Understands patient and customer needs and builds relationships as required to meet departmental goals
Preferred Qualifications
  • Candidate must be a motivated employee capable of working in a fast-paced environment to produce quality and timely results
  • Experienced managing direct reports and processes
  • Strong time management and organizational skills
  • Strong people skills
  • Training experience
  • Experienced in facilitating meetings
  • Ability to effectively maintain a team-work environment
  • Experience authoring and reviewing SOPs, OJTs, test records, and other controlled documents
Experience
  • Detailed knowledge of quality management systems, current Good Manufacturing Practices
  • Expertise with QC principles and compliance requirements
  • Excellent documentation, written, and verbal communication skills
  • Computer literacy, proficiency with Microsoft Word and Excel
  • Working knowledge of statistics, along with advanced software expertise, such as within JMP or LIMS
  • Must have a quality service attitude and focus, exhibit flexibility, and willingness to work additional hours to meet production or laboratory process requirements

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