Position Summary. The Technical Writer is responsible for authoring, reviewing, and maintaining high-quality GMP documentation, including master and executed batch records, SOPs, protocols, reports, and related technical documents. This role ensures compliance with FDA, EU, and ICH regulatory requirements and works cross-functionally with Manufacturing, Quality, Engineering, and Project Management to translate process knowledge into clear, accura...
Analytical Chemist. Cambridge, MA. Position Summary. The Analytical Chemist will develop and validate robust analytical methods for our drug substances and products by leveraging modern techniques with a strong focus on separation sciences. These techniques will be used for characterizing identity, purity, sequence, and impurities in peptides.Ideal candidates will be creative, energetic, and passionate, with a broad knowledge of analytical techni...
SUMMARY. The Senior Gummy Technical Services Specialist is a subject-matter expert responsible for advanced formulation support, manufacturing troubleshooting, scale-up, and process optimization in gummy and confectionery dietary supplement production. This role bridges R&D, Quality, and Operations by ensuring robust formulations, efficient production performance, adherence to GMP standards, and successful commercialization of new and existing gu...
Job Functions. Essential Job Functions. Essential job functions represent the fundamental job duties and accountabilities of the employment position the individual holding the position must be capable of performing. Persons with disabilities can perform these with or without reasonable accommodations. The Director or his/her designee may assign other duties and accountabilities limited to those consistent with the applicable scope of the appropri...
Product Line Manager - College Station, TX. Product line management 50%. Defining the product line's vision and roadmap, and aligning it with the company's goals. Overseeing the development of new products (specific to the US), and ensuring they meet customer needs. Working with European Innovation team to ensure products developed by that team are fit for US market. Analysing market trends and customer feedback to identify opportunities for grow...
The qualified candidate will take an active role in supporting drug development by applying a variety of analytical methodologies to support physical and chemical characterization of drug substances (including raw materials and intermediates) and drug products. Working knowledge of analytical (e.g., HPLC-UV, HPLC-MS, GC-MS, spectroscopy) and physical chemical techniques (e.g., particle size, dissolution) used for the characterization of pharmaceu...
Responsibilities. Perform routine purity, identity, stability, and impurity testing of mRNA and gRNA molecules, including capped species, poly A tail, and concentration. Support analytical characterization of LNP formulations (encapsulation efficiency, particle size, stability, etc.). Execute methods including HPLC/UPLC, UV/VIS/FL spectroscopy, ELISA, PCR, and other nucleic acid assays. Assist with method development, comparability studies, proce...
Essential Duties and Responsibilities. Lead the development and execution of commissioning, qualification, and validation protocols for various equipment and systems. Responsible for all phases of the CQV activity, including requirements gathering, validation planning, protocol generation, test execution, configuration documentation, and system release. Executes validation activity in a timely manner, planning and proactively pursuing details to ...
Scientist. Location: RTP, NC. We are seeking an experienced upstream/midstream scientist to support the development and scale-up of biological production processes used within the biopharmaceutical industry. This role involves working onsite in a modern facility and contributing to the production of biological materials that enable effective testing, optimization, and characterization of product performance. Responsibilities. Produce and characte...
Clinical Laboratory Manager. We are seeking an experienced and driven Clinical Laboratory Manager to help build and scale our CLIA-certified laboratory operations. In this role, you will work directly with our CLIA Laboratory Director to launch novel proteomic LDTs focused on early chronic disease detection and human performance. You will also support the development of clinical chemistry assays and oversee coordination of our biobank. Key Respon...
Validation Engineer II—Prince George County, Virginia. Essential Duties and Responsibilities. Lead the development and execution of commissioning, qualification, and validation protocols for various equipment and systems. Responsible for all phases of the CQV activity, including requirements gathering, validation planning, protocol generation, test execution, configuration documentation, and system release. Executes validation activity in a timel...
