Manager, Validation Services

Location US-IL-Chicago
Posted Date 1 month ago(2/21/2018 9:05 AM)
Adello Biologics, LLC


Adello Biologics is a privately held, U.S.-based biotechnology company that leads with science to accelerate development and drive manufacturing efficiency. The company's aim is to provide high-quality, affordable biosimilars to patients worldwide. Headquartered in Piscataway, NJ and driven by a team of highly skilled industry veterans, Adello is advancing a strategic pipeline of proteins and complex monoclonal antibodies with lead candidates in oncology and immunology. For more information, visit


Our vision is to make biosimilar medications affordable. We are seeking candidates interested in contributing to a bourgeoning field that has the potential to help millions of patients. As a growing company, Adello Biologics offers real development opportunities for candidates excited to take on responsibility, make an immediate impact and help us achieve our vision. As part of a close knit team, you’ll have the opportunity to work in a unique, high science industry while expanding your career. We are seeking a Manager, Validation Servicesto be based out of our Chicago, IL location.



The Manager, Validation is a regular employee in a full-time exempt position at Adello Biologics, LLC, in Chicago, IL. This employee will be responsible for managing the Validation Program, including the management of significant validations as assigned while taking risk based validation approaches. The role shall also develop and perform business strategies related to validation processes to ensure best practices are consistently performed. The position will also support organization objectives and validation corporate policies.


Essential Duties and Responsibilities:

  • Managing the Validation Maintenance program, inclusive of validation plans, schedules and driving operational improvements into the manufacturing site. 
  • Establish and maintain the Master Validation Plan.
  • Develop validation best practice templates and training program and perform the training to all applicable employees.
  • Create and maintain compliant Statistical Technique. Test Method Validation, and Software Validation procedures that align with the corporate policies.
  • Review and approve all protocols and reports.
  • Perform and manage validation projects as assigned.
  • Review and understand validation projects to assure comprehensive development of plans to prepare for effective and timely completion.
  • Monitor and evaluate project and validation program progress and results.
  • Maintain and enhance cross-functional team relationships. Work with divisional customers, internal functions, and suppliers to accomplish quality and business objectives, and to maintain and improve the quality of communication.
  • Provide guidance and approval regarding quality strategies and approaches.
  • Work with other Management, develop budgets, and monitor spending.
  • Understand and effectively participate in design control activities as applicable.
  • Interface with regulatory agencies as required (FDA, ISO, International)
  • Manage project and personnel performance including direct reports and contract resources.
  • Oversee a wide range of activities assuring that processes, systems, facilities and equipment at contract manufacturing organizations comply with accepted GMPs and regulatory expectations utilizing a life-cycle approach, risk management tools (such as FMEA) and principles
  • Develop, establish and manage global validation program via use of systems, policies, processes, procedures and controls to ensure the quality of processes and products conform to established cGMP standards and regulatory requirements. Harmonize site practices where it makes sense.
  • Own the Validation Master Plan for the Chicago site.
  • Develop and maintain/update Validation SOPs to ensure consistent application of requirements and strategies.
  • Develop and maintain a validation event (i.e. re-qualification) scheduling/triggering program within the CMMS environment or other compliant arena.
  • Demonstrated mastery of root cause analysis, investigation tools and methodologies related to protocol execution.
  • Develops and maintains departmental metrics and key performance indicators (KPIs).
  • Provides training and technical development among validation team.
  • Responsible for coordinating activities to support departmental operation.




  • Minimum of bachelor’s degree in a scientific or engineering discipline.


  • Minimum of 7 years’ experience in Bioscience, Quality and/or Pharmaceutical industry.



  • Excellent verbal and written communication skills with all levels of management and other technical organizations.
  • Excellent negotiation and people skills
  • Lead by example and demonstrate attitude to motivate others
  • High initiative, ownership and sense of urgency to support business needs
  • Knowledge of and experience with FDA, ISO, and international auditing.
  • Knowledge of risk management, design control, process validation, inspection, and auditing principles.



General Working Environment:

  • Some time spent in an office doing office work (reading, writing, reviewing, and editing documents).
  • Significant amount of time spent in the facility, in manufacturing the R&D environments.
  • Must be able to work extended hours or weekend hours, as may be required.



  • No extraordinary noise levels.



  • Must be able to lift at least 25 lbs.



  • No extraordinary requirements.



  • High-paced demanding environment to meet ambitious project goals.



  • No travel required.



 Adello Biologics, LLC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Adello Biologics, LLC complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, and transfer, leaves of absence, compensation and training.


Notice To Agency And Search Firm Representatives  

Adello Biologics is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Adello employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Adello. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.



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