Senior Scientist, Drug Product Development | BioNJ Talent Services

Senior Scientist, Drug Product Development

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 (CHART™) 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 successful candidate will be a highly motivated individual ready to work within a Technical Operations group consisting of multi-discipline technical background professionals supporting Drug Product (DP) development and manufacturing.

The pharmaceutical scientist will have experience in developing drug products and understand the complexities and regulations associated with the drug product development process. The candidate will have the opportunity to work with a variety of dosage forms across all stages of development (Phase I to late stage Phase III), with initial primary responsibilities with small molecule dosage forms including solid oral dosages, with additional growing areas such as drug delivery platforms and combination products development.

Roles and Responsibilities
Fully integrated team member of the drug product development team supporting formulation and process development (currently managed at CMOs) including formulation design, data review and analysis, critical process parameter identification, stability study review and trending, process transfer, and batch record development and review
Evaluate and develop drug delivery systems for parenteral and oral products in the pipeline as necessary
Support/ Lead externally managed studies to characterize the product manufacturing process to determine critical process parameters and material attributes and their relationship to product quality attributes and process performance
Support technical troubleshooting including deviation handling and investigations
Oversee clinical manufacturing of for small molecule, solid oral dosage form drug products. This may expand to large molecule biologics, combination products or medical devices, as needed
Contribute to CMC regulatory submissions

Qualifications: 

Requirements
BS degree in a Pharmaceutical Science or Engineering, or related discipline with 4 – 8 years of Pharmaceutical and/or Medical Device industries including drug product development experience (or)
MS degree in a Pharmaceutical Science or Engineering, or related discipline with 2 - 4 years of Pharmaceutical and/or Medical Device industries including drug product development experience (or)
PhD degree in a Pharmaceutical Science or Engineering, or related discipline with 0 – 2 years Pharmaceutical and/or Medical Device industries including drug product development experience.

Experience and Skills
Strong Scientific and/or Engineering knowledge of the drug product development process for solid oral dosages, drug delivery technologies and/ or combination products.
Knowledge of formulation development for small molecules to support oral, and potentially other dosage forms, drug products.
Engineering background with advanced pharmaceutics degree is a plus
Experience with medical devices or combination products a plus.
Experience working with external contract manufacturers is a plus.
Solid Knowledge of current Good Manufacturing Practices (GMPs).
Excellent oral and written communication skills.
Strong interpersonal skills, a collaborator/ team player, open minded to the diverse opinions of others.
Ability to produce highest quality and timely work product/ documents with limited direction.
A superior work ethic and a strong personal desire for success. A good balance of confidence and humility.
Must be passionate about Amicus and rare diseases and orphan drugs.

Travel
15-25%

Additional Job or Internship Information
Position Type: 
Full time job
Function: 
Drug Development