Pilot Plant Technical Lead

US-IL-Chicago
2 months ago(11/21/2017 9:39 AM)
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 Pilot Plant Technical Lead to be based out of our Chicago, IL location

 

Responsibilities

SUMMARY:

The role of Manufacturing Science and Technology (MS&T) is to ensure sustainability, control and constant state of validation of our products across their life-cycle. It is accountable for introducing and transferring technology in close collaboration with Development, Quality and Production, reducing process variability of products in production with a strong focus on process understanding.

 

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. This position will be located in Chicago, IL.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES:

The Pilot Plant Technical Lead will report to the Head of MSAT, must be knowledgeable of Upstream and Downstream monoclonal antibody (mAbs) processing, and will be responsible for the product tech transfers to the Suite 1 Pilot Plant.

 

  • Dotted line reporting to the Head Bioprocess Product Development (BPD) and the Pilot Plant Manufacturing Supervisor.

 

  • Responsible for the Pilot Plant process (i.e. process fit, engineering runs, batch records, SOPs).

 

  • Work closely with Site Quality and Operations in executing Pilot Plant process deliverables (i.e. IOQ/PQ, SOPs and personnel training, PMs, Batch Records, raw/consumable materials specifications, etc.) and write and complete process deviation investigations.

 

  • 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.

 

  • 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 6 years with a B.S. degree, or 4 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.
  • Strong interpersonal and communication skills with demonstrated ability to work within a team environment are 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

WORKING ENVIRONMENT/PHYSICAL REQUIREMENTS:

General Work Environment:

  • General office environment.
  • May be required to work in or walk through laboratory settings.

Noise:

  • No extraordinary noise levels.

Standing/Lifting:

  • Must be able to walk to and through manufacturing cleanroom settings.
  • Must be able to life at least 25 lbs.

Visual:

  • No extraordinary requirements.

Stress:

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

Travel:

  • Occasional travel to manufacturing sites.

 

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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