Manager, Pilot Plant

US-IL-Chicago
3 weeks ago
ID
2017-2032
Adello Biologics, LLC

Overview

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 www.Adellobio.com

 

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, Pilot Plant to be based out of our Chicago, IL location

 

Responsibilities

SUMMARY:

Adello Biologics is currently recruiting a Manager, Pilot Plant, to be located in Chicago, IL. Adello is a fully-integrated biosimilar developer headquartered in New Jersey, one of the major biotech hubs in the United States. At Adello, we lead with science to accelerate development and drive manufacturing efficiency with the goal of providing high-quality, affordable biosimilars to patients worldwide.

The pilot plant facility plays an integral role in the development of biologically-made products in the Adello pipeline by producing batches for early-stage clinical trials and investigational biologics for preclinical studies. The current focus of the facility is to support the scale-up of development upstream and downstream processes, and transfer of these processes to Adello’s Manufacturing division.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES:

 

The Manager, Pilot Plant will report to the Head of  MSAT and maintain the pilot plant in cGMP through management of manufacturing, engineering and maintenance personnel and ensure that R&D project timelines are not impacted by equipment or facility issues. The Manager will be recognized as a bioprocess expert for Upstream and Downstream processing within the organization and serve as a technical expert providing support to the R&D Bioprocess and MS&T teams.

 

  • All job functions will be performed in compliance with all local, state and federal regulations and guidelines including FDA, EPA, and OSHA and comply with all Company and Site policies and procedures.
  • Collaborate within Adello to learn from colleagues and identify and implement best practices within the Company.
  • Execute capital projects related to the pilot plant and laboratory equipment within budget, implement new technologies for the pilot plant as time and resources allow, and lead the continuous improvement of pilot plant practices and procedures related to engineering, maintenance, operations, quality, safety, and environmental control.
  • Dotted line reporting to Bioprocess Product Development in NJ.
  • Work closely with Site Quality and Operations in executing Pilot Plant deliverables (i.e. IOQ/PQ, SOPs and personnel training, PMs, Batch Records, raw/consumable materials specifications, etc.) and write and complete investigations.
  • Ensure quality and compliance in all work that is performed.
  • Technical data will be prepared and presented to the R&D teams and to management as needed.

Qualifications

PREREQUISITES:

 

  • A Bachelor’s degree in Chemical or Mechanical Engineering or a related discipline is required.
  • A minimum of 8 years with a B.S. degree, or 6 years with an M.S. degree, of significant engineering and/or operational experience is required.
  • Experience in a biopharmaceutical company in manufacturing of biologics in Pilot Plant and/or Commercial manufacturing environment under cGMP is preferred. (i.e. technical support staff).
  • Successful track record of team leadership and staff management preferred.
  • A minimum of 3 years’ experience in project management in plant engineering and maintenance in an FDA-regulated manufacturing environment is preferred.
  • Must have a strong technical knowledge in the areas of process equipment, facilities, utilities, and system design, construction, operation, and maintenance.
  • Strong interpersonal and communication skills with demonstrated ability to work within a team environment are required.
  • Must be able to effectively and positively influence the environment and colleagues.
  • An open, approachable style as a leader of a service organization is required.
  • Must have a proven track record of project completion and the ability to work with a sense of urgency.
  • Must be able to balance multiple priorities and projects at the same time, and be able to change priorities as needed by the business.
  • Must have experience writing technical documents and developing operating/process procedures.
  • Must be able to work independently and effectively lead others.
  • Must have strong oral and written communication skills – knowledge of Microsoft Office (Word, Excel, Outlook, and PowerPoint) is required.
  • Must be willing and able to work in Chicago, IL

 

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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