Associate Director, Instrumentation Optimization

Req ID #:  71222
Location: 

Wayne, PA, US, 19087

For 70 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about.

Job Summary

Responsible for management and coordination of continuous improvement within Biologics Computer Instrumentation management including support and implementation of business optimization projects and initiatives. Manages the process of instrument qualification and validation for Biologics including project management teams and the Biologics Computer System Validation team.  Assist in developing and directing instrumentation processes, from procurement to release into production, compliant with all applicable regulations.  Manage the acquisition, qualification, validation and maintenance of laboratory instrument software systems and software modifications including associated hardware/infrastructure components.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES
  • Manages the Biologics’ pipeline of instrumentation related projects, including prioritization to assure alignment with overall business strategic goals
  • Drive the assessment and enhancement of Biologics instrumentation program management metrics (e.g., department, portfolio, program, project levels) in collaboration with Global CSV Operations
  • Manage multi-site projects and programs as required
  • Manage project resources as required
  • Develop qualification, validation or maintenance documentation as required
  • Serve as a change agent in the organization, build and motivate project teams and foster positive relationships with and among team members.
  • Participates and represents Biologics as a contributing member to global forums and ensuring compliance with prioritized efforts.
  • Network with experts at other sites around the organization to establish and share best practices.
  • Oversee the Global Biologics Validation Operations Team to ensure an efficient, compliant and cost-effective delivery of testing, computerized system administration and validation on a day-to-day-basis 
  • Drive optimization, standardization and harmonization of instrumentation related processes and templates between Biologics sites and with other businesses
  • Author and update local and enterprise instrumentation related standard operating procedures
  • Author and review all deliverables of the Computer System Development Lifecycle
  • Be an active Biologics’ participant in the implementation and oversee of Global or Business unit driven Data Integrity initiatives
  • Evaluate equipment processes against industry best practices and regulatory guidance and regulations to ensure Biologics is in compliance with regulatory expectations and following industry standards and best practices
  • Provide point of contact consultation as senior subject matter expert in the field of Computer System Development Lifecycle, Software Quality, Computer System Validation, Equipment Qualification, Data Integrity and Regulatory Expectations (GLP, GMP, MHRA, FDA, EMA etc.)
  • Proactively resolve conflicts between compliance requirements and project/business constraint
  • Responsible for personnel management activities such as: scheduling, personnel actions (hiring, promotions, transfers, etc.), training and development, providing regular direction and feedback on performance, disciplinary actions and delivering annual performance and salary reviews.
  • Assist in creation of and provide recommendations on organizational structure, staffing requirements and succession plans for personnel under their guidance
  • Provide recommendations for creation of departmental budget 
  • Support the policy of equal employment opportunity through affirmative action in personnel actions.
  • Ensure adherence to pertinent regulatory requirements and to departmental policies, practices and procedures [SOPs, safety procedures and biosafety protocols].
  • Perform all other related duties as assigned.
MINIMUM QUALIFICATIONS
  • Bachelor’s degree (B.A./B.S.) or equivalent in scientific, computer science, and engineering or related discipline.  
  • 5-7 years related experience in equipment management, qualification and/or validation. Prior experience working in a GxP laboratory is preferred.
  • An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
  • Test or validation certification preferred.
  • Comprehensive knowledge of regulatory requirements, including GxPs, Part 11, and OECDs as they pertain to computerized systems is preferred.  
  • Strong interpersonal skills including influencing and aligning.  
  • Strong written and verbal communications including large, multinational audiences and across levels of the organization.
  • Demonstrated ability to build consensus and affect change across departmental boundaries.
  • This position may require domestic and international travel.

About Biologics Testing Solutions

With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address challenging projects for biotechnology and pharmaceutical companies worldwide. Offering a variety of services such as contamination and impurity testing, protein characterization, bioassays, viral clearance studies and stability and lot release programs, we support clients throughout the biologic development cycle, from the establishment and characterization of cell banks through preclinical and clinical studies to marketed products. Whether clients need stand-alone services, a unique package of testing, or insourced support, our Biologics group can create a custom solution to suit their needs.  Each year more than 20,000 biologic testing reports are sent each and over 200 licenses products are supported by our biologics testing solutions team.

 

About Charles River

Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.

 

With over 17,000 employees within 90 facilities in 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client’s unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. And in 2018, revenue increased to $2.62 billion.

 

At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of ~85% of the drugs approved by the FDA in 2019.

 

Equal Employment Opportunity 

 

Charles River Laboratories is an Equal Opportunity Employer - M/F/Disabled/Vet