Process Development Associate, Small Molecule Drug Product Dev. (210C)
Job Type: W-2 Contract
Duration: 12 months
Location: Onsite in New Haven, CT with some remote work option
Up to 15% travel, with ability to work independently from remote locations.
Our client is seeking an experienced Process Development Associate, Small Molecule Drug Product Development who will provide laboratory support by using a combination of strong laboratory skills with experience in formulation design, equipment selection, and process scale-up to help expand their solid oral dosage development capabilities in support of an emerging small molecule portfolio.
Essential Skills and 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).
- Small Molecule product development 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.
- 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.
- 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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