Job Description

Title: Senior Analytical/ QA Scientist

The Opportunity

In this newly created role, as a you'll play a key role in the development and validation of our manufacturing processes, with a particular focus on the quantitative analysis of our drug-releasing microspheres.

You’ll specialize in quantitative analysis related to the development and validation of our unique manufacturing process for drug-releasing microspheres. Your responsibilities would include hands-on and oversight of development, conduction and validation of in-process and batch release assays, drug-product stability studies, maintenance of standards and analytical reagents, managing CROs for outsourced methods, environmental monitoring, and writing analytical method SOPs.

About Us

We are a clinical-stage biopharmaceutical company specializing in the development of novel long-acting therapeutics. Our team invents, develops and uses novel drug delivery technologies that enables controlled, predictable, and sustained release of drugs—peptides, proteins, and small molecules—over weeks or months. Our approach enhances pharmacokinetics, efficacy, and safety while significantly reducing dosing frequency.

Our future efforts will focus on the development of unique long- and ultralong-acting anti-obesity peptides. Additionally, we will be working on developing long-acting therapeutics in other areas, including oncology, immunology and immuno-oncology.

Your Role

• Develop & Conduct Assays:
• You’ll oversee and conduct the development of in-process and batch release assays to ensure our drug products meet the highest standards. You’ll also be heavily involved in drug-product stability studies to ensure product integrity over time.
• Maintain Standards & Reagents:
• Establishing and maintaining analytical standards and reagents will be a key part of your role, ensuring they’re always up to date and ready for use in our assays.
• Work with CROs:
• You’ll manage relationships with Contract Research Organizations (CROs) , outsourcing some of our analytical methods, like mass spectrometry assays. You’ll ensure that the work done externally aligns with our internal standards and timelines.
• Environmental Monitoring:
• You’ll oversee environmental monitoring to ensure our manufacturing and lab spaces are up to the standards required for quality assurance.
• Write SOPs:
• You’ll write and maintain analytical method SOPs (Standard Operating Procedures) , making sure all procedures are documented clearly and consistently for use across the team.
• Attention to Detail:
• This role requires you to keep meticulous records and pay close attention to the finer details—accuracy is key to ensuring the success of our processes.

Who you are

Education & Experience:

• You’ll need a BS, MS , or PhD in Analytical Chemistry , Chemistry , Biochemistry , Chemical Biology , or a similar field. Your academic background should come with practical experience in lab work and analytical chemistry.
• We’re looking for someone with at least 8 years of hands-on experience in instrumental analysis (e.g., HPLC, LC-MS, UV-VIS, IR, spectrophotometry) and techniques like liquid handler automation, titration, and microscopy.
• Experience with quantitative analysis and maintaining analytical standards is important, as well as ensuring thorough record-keeping and documentation.
• Having 5+ years of experience in an analytical chemistry or biochemistry role would be ideal. If you've worked in QA or a regulated environment, even better!
• Outsourcing & CRO Management: You should have some experience managing or outsourcing methods to CROs (like a mass spectrometry assay ), ensuring all work meets ProLynx's standards.
• Attention to Detail: Precision is crucial. You’ll be managing complex data and running assays, so attention to detail and the ability to accurately document all findings are essential.
• Your colleagues would describe you as an open and articulate communicator.
• You bring an openness to learn from diverse perspectives and collaborate on multidisciplinary teams.

We believe in building balanced teams. We are an equal opportunity employer. We do not discriminate in regard to race, color, religion, national origin, age, sex, sexual orientation, gender identity, marital status, ancestry, physical or mental disability, veteran status, or any other legally protected characteristics.

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