Process Scientist

Job Title:

Process Scientist

Job Description

The Process Scientist I supports the Critical Raw Materials team by manufacturing liquid components used in in‑vitro diagnostic (IVD) products. This role focuses on immune‑system-based reagents such as antibodies, antigens, and serum proteins, which are produced, tested, and prepared for use on diagnostic analyzers. The position combines hands‑on laboratory work with documentation and coordination in a regulated, Good Manufacturing Practice (GMP) environment to help deliver accurate diagnostic solutions that improve patient outcomes.

Responsibilities

+ Perform material processing and reagent formulation for bulk intermediates and liquid components used in IVD products.

+ Support the production of serum proteins and OEM liquid products according to established procedures and quality standards.

+ Determine reprocessing needs for calibrators, controls, and antibodies with guidance from established protocols and senior team members.

+ Maintain Good Laboratory Practices (GLP) and contribute to laboratory and equipment upkeep, including routine cleaning, organization, and basic maintenance.

+ Conduct in‑process testing and final quality control (QC) for serum protein products, following documented methods and specifications.

+ Assign calibrator values and control ranges to optimize diagnostic kit performance and ensure reliable analytical results.

+ Monitor internal control supplies, proactively identify low inventory levels, and manufacture new controls as needed to support continuous production.

+ Perform second‑checks on calculations, documentation, and test results to ensure accuracy, compliance, and data integrity.

+ Use laboratory instruments such as pH meters, balances, and mixers to prepare and verify reagents and solutions.

+ Document all laboratory activities accurately and thoroughly in compliance with regulated environment requirements and good documentation practices.

+ Collaborate closely with a cross‑functional, highly collaborative team to support critical raw material supply for diagnostic products.

+ Follow GMP and safety procedures consistently to maintain a controlled, compliant manufacturing environment.

Essential Skills

+ Bachelor's degree in Biology, Chemistry, Biochemistry, or a closely related scientific discipline.

+ Ability to work effectively in a regulated environment and follow established procedures and standards.

+

Experience with good documentation practices, gained through academic laboratory work or industry experience.

+ At least 6 months of laboratory experience in an academic or industry setting.

+ Hands‑on experience using laboratory equipment such as pH meters, balances, and mixers.

+ Foundational knowledge of biochemistry, biology, or related laboratory sciences relevant to reagent preparation and testing.

+

Experience with reagent preparation, pipetting, and basic laboratory techniques.

+ High attention to detail and strong organizational skills to ensure accurate processing, testing, and documentation.

+ Self‑starter with the ability to work independently while also contributing to a collaborative team environment.

+ Motivation to perform work that directly improves patient lives through more accurate diagnosis.

+ Comfort working within Good Laboratory Practices (GLP) and adhering to quality and safety standards.

Additional

Skills & Qualifications

+ Experience working in a GMP manufacturing environment.

+ Previous manufacturing experience in either GMP or non‑GMP settings.

+ Exposure to or experience with in‑vitro diagnostics (IVD) products and processes.

+ Previous experience in biotech, reagent production, or related life science manufacturing.

+ Familiarity with quality control processes for reagents and diagnostic components.

+ Understanding of immune‑system-based reagents such as antibodies, antigens, and serum proteins.

+ Strong communication skills to interact effectively with cross‑functional teams and support collaborative problem‑solving.

+ Demonstrated reliability and strong work ethic, as verified by references.

Work Environment

This role operates within a GMP manufacturing environment that supports the production of critical raw…