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Title : AXG- Process Dev Associate II -017
State : Connecticut   Date : May 17, 2021
Experience Level :  
Position Type : Process Dev Associate II      
Description
This position is for a leading pharmaceutical company. Below are the details of the engagement. If you are available and interested please send me your updated word resume & your expected hourly rate on W2 ASAP.
Looking forward to hearing from you soon.

Work Location: New Haven, CT  

Job Title: Research Associate III

Duration: 12+ months (extendable) contract on W2


Summary:

The Client’s Global Product Development organization is seeking an experienced technical professional to expand our solid oral dosage development capabilities in support of an emerging small molecule portfolio.  The Associate II, Small Molecule Drug Product Development will couple strong laboratory skills with experience in formulation design, equipment selection, and process scale-up. 

Responsibilities:
  • Laboratory support for preclinical candidates including assessment of physicochemical properties, evaluation of solid state landscape, and preformulation development. 
  • Laboratory support for molecules entering clinical development will focus on rapid formulation prototyping to focus subsequent formulation and process development efforts at third parties.
  • Provide technical stewardship of formulation design, equipment selection, and scale-up readiness at third parties in support of cGMP drug product manufacture on multi-kilogram scale.  Ensure third parties meet the Client’s exacting standards for technical excellence and quality compliance.
  • Provide technical stewardship to enable successful tech transfer to cGMP facilities.  Provide insightful technical review of batch records and change controls.  Partner with CMOs to diagnose and remediate process upsets.  Partner with QA groups to support product impact assessments and establish CAPAs.
  • Maintain open and direct communication with technical counterparts at third party manufacturers.  Ensure CMO readiness for process validation, pre-approval inspection, and commercial launch.  Provide on-site technical support during process validation and pre-approval inspection, and as needed at earlier stages of development.
Qualifications :

Essential Qualifications:
  • B.S. Pharmaceutical Sciences or Chemical Engineer with minimum 5 years industrial experience in the biopharma industry (or M.S. with minimum 5 years industrial experience).
  • Deep understanding of formulation design, process development, equipment selection and scale-up for solid oral dosage manufacturing processes.
  • Expertise in development and manufacture of amorphous solid dispersions.
  • Ability to remotely manage process design, development, and scale-up activities at third parties.
  • Up to 15% travel, with ability to work independently from remote locations.
  • Strong understanding of cGMPs and regulatory guidances.
  • Strong understanding of Quality by Design (QbD) principles of process design.
  • Technical expert who will remain abreast of the latest scientific and regulatory trends pertaining to solid oral dosage product design and manufacture.  Evaluate emerging technologies with potential to improve cycle time, supply chain robustness, and/or product quality.
Preferred Qualification:
  • Experience in late-phase process development, including process risk assessments, multivariate DOE studies, and assessment of parameter criticality.
  • Experience in development of drug products targeted toward pediatric patient populations.
  • Experience in planning and implementation of post-approval process and formulation changes.
  • Experience in development of modified release drug products.
  • Experience in development of combination drug products.


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Many Thanks,   

Sree Kanth
Recruitment Manager
Sree@newageclinical.com

NewAgeSys, Inc.
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