Lead, Device Programs

US-NJ-Piscataway
2 weeks ago
ID
2017-2008
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 Lead, Device Programs to be based out of our HQ in Piscataway, NJ.

 

Responsibilities

SUMMARY:

Adello has an opening for a leader responsible for applying knowledge and expertise in the area of biologic / device combination-product development to a wide range of biosimilarproduct candidates. Combination products are defined in 21 CFR 3.2(e). Activities span earlystage (preIND) and latestage development (postIND) supporting BLA filings, and subsequent lifecyclemanagement activities.

 

Essential Duties and Responsibilities:

  • Responsible for all activities involving development of biologic / device drug-product processes
  • Responsible for device design meeting regulatory requirements, e.g. device design history files and design controls, but adherence to GMPs in daily operations is responsibility of Manufacturing and QA
  • Responsible for multiple projects, managing a group of no more than two scientists and engineers, and managing largely outsourced device-related activities at CMOs and CROs
  • Responsible for crossfunctional (matrix) and people management
  • Accountable for building and leading a high-performing team that contributes to technical and strategic discussions to advance platforms and product candidates
  • Accountable for timelines and program progress, and for communicating development progress and issue resolution
  • Accountable for authoring relevant sections of regulatory submissions and BLAs, and for delivery of documentation including (but not limited to) responses to regulatory agency questions
  • Accountable for liaising effectively with internal departments (Commercial, Regulatory Affairs, Development, Operations, etc.) to ensure that the proposed design meets their requirements and expectations
  • Facilitate the identification and management of external contracts as required
  • Facilitate close working relationships with suppliers and design consultants, and contribute to management of external collaborations
  • Facilitate strategy for creating and streamlining processes between Development and Manufacturing / Commercial partners

Qualifications

PREREQUISITES:

Education & Experience:

  • Bachelor’s degree in engineering or related field required, MS desired; relevant industry experience required

SPECIALIZED KNOWLEDGE AND SKILLS:

  • Expertise in design controls, biocompatibility, sterilization validation, packaging validation, and shelf life stability programs required
    • Minimum of 10 years of experience in device development and commercialization with demonstrated success leading enterprise-wide programs in the biotech / pharmaceutical industry required
    • Significant latestage CMC experience, an in-depth knowledge of relevant compliance systems, and experience in authoring relevant sections in regulatory submissions (IND, BLA, MAA, etc.) required
    • Demonstrated expertise with aseptic processing, and expertise in technology transfer for parenteral drug-product manufacturing (both syringes and auto injectors) required
    • Experience with primary and secondary container-closure systems required
    • Experience defining and executing development based on QbD principles preferred
  • Supervisory and leadership experience, and experience with crossfunctional (matrix) and people management required
  • Outstanding organizational and communication skills (especially technical writing, verbal, and presentation), excellent people skills, and a demonstrated ability to function effectively across a matrix organization required
  • Previous experience managing technology transfers and supporting production at CMOs is preferred
  • Demonstrated launches of combination products for biotechnology compounds preferred

WORK ENVIRONMENT AND PHYSICAL DEMANDS:

General Work Environment:

  • Standard office environment for deskwork.
  • Significant amount of time doing computer work (reading, writing, reviewing, and editing documents).
  • Extensive time in cleanroom laboratories also required.

Noise:

  • No extraordinary noise levels.

Standing/Lifting:

  • Must be able to lift 25 lbs.

Visual:

  • No extraordinary requirements.

Stress:

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

Travel:

  • This position will be based in Piscataway, NJ and will require occasional travel to support the global product pipeline.

 

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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