Manager, Biosimilar Development Operations

US-NJ-Piscataway
2 weeks ago
ID
2017-1998
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, Biosimilar Development Operations to be based out of our HQ in Piscataway, NJ.

 

Responsibilities

SUMMARY:

The successful candidate will be responsible for managing the support of technical activities in the Biosimilar Development group. The incumbent would preferably have the experience working in a biologics development environment, administration of laboratory software, and management of critical reagents. The successful candidate will be a highly motivated, well-organized, detailed-orientated professional with the ability to work effectively in a fast-paced and multi-disciplinary environment.

ESSENTIAL DUTIES AND RESPONSIBILITIES

 

Manage the Biosimilar Development Operations group activities:

  • Laboratory software support, data management, and Hardware support
  • Assume roll as the software SME to coordinate and supplement IT to support the installation, administration, and troubleshooting of laboratory software: LIMS, ELN, Empower, SpectraMax, etc.
  • Coordinate installation, maintenance, and calibration of laboratory equipment with the Facilities group
  • Establish and maintain temporary databases to organize analytical data to bridge to LIMS implementation
  • Assist scientists in the preparation of graphs and tables from either LIMS or the interim database to support regulatory filings and publishiny

      Critical Reagents and Sample Management

 

  •  Establish and maintain an inventory tracking systemCoordinate procurement of the reference product for biosimilars
  • Establish chain of custody for critical reagents
  • Receive,schedule, and distribute samples for analytical testing

 

                       Laboratory backroom support

 

  • Liaison to Purchasing department and vendors for ordering supplies and equipment
  • Organization of the laboratories
  • Maintenance and handling controls for chemicals and laboratory waste
  • Lead organization efforts for laboratory safety (working with EH&S)

 

  • Represent the company in discussions with external parties (conferences, regulatory meetings, CROs/CMOs, business partners) 

 

Qualifications

PREREQUISITES:

Education:

  • Bachelor’s degree with IT, Business, or related field OR equivalent industrial experience.

Experience:

  • 3+ years administration/tech support for laboratory software: LIMS, ELN, Empower, SpectraMax, etc.
  • Strong experience with building and maintaining database and complex spreadsheets with high integrity data
  • Experience with statistical data analysis software is a plus (e.g. JMP)
  • Experience in managing inventories critical materials is a plus

 

SPECIALIZED KNOWLEDGE AND SKILLS:

  • Strong communication and technical writing skills

 

WORK ENVIRONMENT AND PHYSICAL DEMANDS:

General Work Environment:

  • General office setting.
  • Must be able to work extended hours or weekend hours, if necessary.
  • High paced demanding environment to meet ambitious project goals.

 

Standing/Lifting:

  • May need to move laboratory equipment and supplies.

 

Travel:

  • Limited (<5%) travel may be 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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