Process Development Associate
About The Position
The Process Development Associate supports the development of manufacturing processes by conducting experiments, analyzing data, documenting results, and working with senior scientists and engineers to implement process improvements. The role focuses on analytical development and testing of process impurities in drug substances and intermediates, supporting product development, investigations, routine testing, and regulatory submissions. The associate develops and implements fit-for-purpose analytical methods, prepares technical reports, documents laboratory work according to GMP guidelines, and contributes to analytical development teams. The role also involves staying current with analytical development literature and technologies and supporting method development, qualification, and transfer.
Requirements
- Bachelor’s degree; or an associate’s degree and 2 years of scientific experience; or a high school diploma/GED and 4 years of scientific experience.
Nice To Haves
- Experience with protein assays, particularly ELISA and common formats for measuring protein-protein interactions.
- Experience with molecular biology, particularly qPCR and DNA isolation.
- Experience with GDP documentation and Electronic Laboratory Notebook systems.
- Experience in a GMP-regulated environment and with regulatory filings (IND, BLA, and NDA) and ICH Guidelines.
- Experience with Microsoft Office software, particularly Word, PowerPoint, and Excel.
- Experience with data analysis and software including JMP, R, SAS, and/or GraphPad.
- A positive, innovative approach to challenges; champions new insights and initiatives and applies others’ creativity to improve unit performance.
- Effective communication skills, including maintaining communication mechanisms and bridging communication across individuals, units, and organizations.
- Social skills, including communicating with tact and sensitivity and helping others feel respected, valued, and understood.
Responsibilities
- Develop and implement fit-for-purpose analytical methods for impurity release testing.
- Perform analytical testing to evaluate residual process impurities in drug substances and drug substance intermediates.
- Prepare technical reports for investigations, product and impurity characterization, and regulatory submissions.
- Document laboratory activities according to GMP guidelines.
- Generate, analyze, and interpret analytical data to support product development investigations, routine testing, and regulatory submissions.
- Stay current in analytical development, including relevant literature and technology developments.
- Support analytical projects involving method development, qualification, and transfer.
- Participate in analytical development teams, including product and process development teams and product quality teams, by providing analytical updates and documentation.
- Work closely with senior scientists and engineers to implement process improvements.
Benefits
- Health and welfare plans for staff and eligible dependents.
- Retirement and Savings Plan with company contributions.
- Group medical, dental, and vision coverage.
- Life and disability insurance.
- Flexible spending accounts.
- Discretionary annual bonus program, or a sales-based incentive plan for field sales representatives.
- Stock-based long-term incentives.
- Award-winning time-off plans.
- Flexible work models where possible.
- Career development opportunities.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
