Quality Engineer, Biologics | BioNJ Talent Services

Quality Engineer, Biologics

Contact Information
Contact Name: 
Amicus Therapeutics
Organization Name: 
Amicus Therapeutics
Position Location: 
Cranbury
Company Profile: 

Amicus Therapeutics, Inc. (Nasdaq:FOLD) is a global biotechnology company at the forefront of advanced therapies to treat a range of devastating rare and orphan diseases. We have a robust development pipeline of treatments for a range of human genetic diseases.
Our lead product candidate, migalastat, is a personalized medicine in late-stage development to treat individuals with Fabry disease on the basis of their genetic diagnosis. SD-101, a product candidate in late-stage development, is a potential first-to-market therapy for the rare genetic connective tissue disorder Epidermolysis Bullosa (EB). We are leveraging our biologics and Chaperone-Advanced Replacement Therapy (CHARTâ„¢) platform technologies to develop novel enzyme replacement therapy (ERT) products for Fabry disease, Pompe disease, and other Lysosomal Storage Disorders (LSDs). Our lead biologics program is ATB200/AT2221, a uniquely engineered Pompe disease ERT that will be administered in combination with a pharmacological chaperone.

Job Description:

Position Summary

The Quality Engineer provides Quality Assurance oversight of biologics development, contract manufacturing, and quality control. Specifically, this position will support the areas of Pharmaceutical Development, Technology Transfer, and manufacturing for new and existing products.The Quality Engineer position will have demonstrated experience to support new and on-going product development and manufacturing of biologics. The successful candidate will be responsible for providing QA support for process/analytical risk assessments, clinical manufacturing, scale-up and qualification/validation activities for drug substance, drug product, and analytical methods.

Roles and Responsibilities
Follows all applicable regulatory requirements, cGMP guidelines, and industry guidance documents as required by the job function
Provides QA review and approval of validation master plans (VMPs), qualification/validation protocols, and final reports for manufacturing, cleaning, equipment and facility validation activities
Provides QA review and approval of qualification/validation protocols for analytical methods. Collaborates with Tech Ops to define and approve product specifications
Conducts material review and approval of product contact components and packaging materials
Provides QA review and approval for new and existing procedures, master batch records, and change controls
Provides QA review and approval for deviations and investigations. Assists the CMO in root cause analysis and impact assessment
Understanding of Quality by Design (QbD) principles as they relate to biologics and manufacturing
Use metrics and data to identify and lead continuous improvement projects within the Quality work streams.
Represent QA in risk assessment activities for Drug Substance, Drug Product, and Analytical Development
Responsible for Quality metrics management, analysis, and trending. Performs quarterly and year-end reporting of manufacturing parameters, stability data, temperature excursions, deviations, and CAPAs.
Regularly meets with QA management team in the development of best practice standards, KPIs, identification of training needs and optimization of resource utilization
Ensure compliance to all compendia and internal requirements (SOPs, Quality Agreements, General and Informational Chapters in multiple compendia as applicable)
Provide onsite CMO oversight of Amicus product manufacturing, as required
Performs other duties related to the position when required by management

Qualifications: 

Requirements
Minimum of a Bachelor’s Degree in the Sciences (Engineering, Biology, Chemistry, etc.
Engineering Degree preferred (Chemical, Biomedical, Mechanical)
ASQ CQE/CQA or Lean Six Sigma certification preferred
Comprehensive hands-on knowledge of biologics manufacturing, validation, and conducting risk-assessments
Must have 6 to 10 years of experience in Biotech manufacturing with an in-depth knowledge of current Good Manufacturing Practices, Quality System regulations, and ISO standards

Experience and Skills
Experience with process and analytical qualification/validation
Problem-solving and troubleshooting skill
Ability to work independently
Strong verbal and written communication skills
Strong interpersonal skills
Knowledge of Quality by Design(QbD)

Travel
20-25% international and domestic travel is required, sometimes on short notice

Additional Job or Internship Information
Position Type: 
Full time job
Function: 
Quality Assurance