Downstream Bioprocess Development Lead - Piscataway, NJ | Biospace
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Downstream Bioprocess Development Lead

Adello Biologics

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Location:
Piscataway, NJ
Posted Date:
2/3/2017
Position Type:
Full time
Job Code:
1708
Salary:
Required Education:
Doctorate/PhD
Areas of Expertise Desired:
Antibody, Biotechnology, Chemical Engineering, Pharmaceutical, Process Development, Process Engineer, Research,

Job Description

SUMMARY:

Adello Biologics is a science-based biopharmaceutical company that develops, manufactures, and commercializes biosimilar medicines.   Adello has an opening for a senior leader in R&D responsible for managing a team of scientists and engineers that develop downstream processes (for drug substance and drug product) for a wide range of biosimilars.  The BPD (Bioprocess Development) team is responsible for process development, process characterization, small-scale process validation, and supporting tech transfer to GMP commercial facilities in Chicago, IL, USA (up to 250-L scale),  Cashel, IRL (up to 2,000-L scale), and CMOs (Contract Manufacturing Organizations).  In addition, BPD supports and improves on-going commercial campaigns in partnership with MS&T (Manufacturing Sciences & Technology in R&D), manufacturing, and quality teams.  Title level will be determined on the basis of skills and experience.

Duties include:
•   Responsible for leading development and characterization of downstream purification bioprocesses for production of therapeutic proteins, spanning mammalian monoclonal antibody production and microbial protein production
o   Providing functional leadership to establish clinical phase-appropriate production processes
o   Facilitating process transfer, scale-up, validation and product / process comparability activities
o   Proactively identifying issues, providing general guidance to resolve CMC project issues, and develop solutions to meet productivity and quality milestones, and objectives
o   Designing and implementing rigorous product-development strategies utilizing DoE (Design of Experiment) and other process-design elements aligned with a QbD (Quality by Design) approach
o   With MS&T, optimizing current processes including reducing COGs (Cost of Goods) and improvement of product quality
o   Delivering development reports and sections of regulatory submissions including comparability, similarity, and QbD risk assessments
•   Responsible for managing a team of scientists and engineers
•   Achieving budget and timeline targets
•   Developing productive relationships with internal and external collaborators / partners
•   Responsible for multiple projects via cross-functional (matrix) management

Requirements

PREREQUISITES:

Skills/knowledge/abilities:
•   Candidate must have a Ph.D. with 5 (or more) years of experience in the biopharmaceutical industry or equivalent with significant emphases on purification-bioprocess development and technology transfer required
•   Recent experience with monoclonal antibodies required
•   Demonstrated ability to function effectively across a matrix organization required
•   Outstanding organizational and communication skills (especially technical writing, verbal and presentation), and excellent supervisory skills required
•   Knowledge of current GMPs, and FDA and / or European validation practices for biopharmaceutical processes required
•   Demonstrated experience with process improvements, knowledge of manufacturing, and understanding of site operations, R&D, and production systems required
•   Demonstrated success with regulatory filings including BLA submissions and product launch preferred

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

Education:
Ph.D. with 5 (or more) years of experience in the biopharmaceutical industry is required

Adello Biologics embraces equal employment practices, including: refraining from discriminating on the basis of race, color, religion, sex, national origin, disability, or protected Veteran status