Process Development, Engineer I/II

We have an immediate opening for a Process Development, Engineer I/II with demonstrate experience with CHO cell lines, mammalian cell culture with aseptic technique, cell culture without use of antibiotics, and design of experiments for the optimization of media for enhanced product titer. Responsibilities will include R&D support for scaleup and process development optimization of lead therapeutic products, and upstream GMP manufacturing efforts.

The Process Development Engineer I/II will have familiarity with various cell cultureware and techniques, cell seed train calculations, and setup and execution of 2L-50L bioreactor runs, including bioreactor software and controls.

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Senior Associate I – Manufacturing Operations

We have an opening for a Senior Associate I – Manufacturing Operations with demonstrated experience and understanding of biologics manufacturing processes and associated manufacturing equipment, and GMP related manufacturing experience.

The Senior Associate I – Manufacturing Operations will operate equipment according to Standard Operating Procedures, maintain records and clean room environment to comply with regulatory requirements, and perform manufacturing operations for the production of clinical and/or commercial products.

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Associate I – Pharmacology

We have an immediate opening for an Associate I to contribute to the Akston Biosciences Pharmacology team by assisting in in vivo studies, performing a variety of laboratory research tasks, and conducting analyses of results.

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Pharmaceutical – Quality Assurance Specialist

Immediate opening for Pharmaceutical – Quality Assurance Specialist with demonstrated in-depth knowledge, proficiency, and experience in Quality Systems/QA activities in regulated pharmaceutical environment. The Pharmaceutical QA Specialist will establish QA procedures, write SOPs, identify and resolve Quality problems in GMP/GLP, investigate and report deviations, conduct quality inspections, and implement document management and control.

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Quality Assurance Specialist/Associate

Two immediate openings for Quality Assurance (QA) Specialists/Associates with demonstrated proficiency in quality systems/QA activities in regulated pharmaceutical environment.

The QA Specialists/Associates will perform QA review of controlled documents, write SOPs, establish QA procedures, coordinate quality activities, identify and resolve quality problems in GMP/GLP, assist in conducting routine inspections, establish and implement document management and control activities.

The successful candidate will have a master’s degree or bachelor’s degree in life sciences; 1-5 years of work experience in pharmaceutical or biotech industries; a minimum of 1 year of QA experience in support of GMP/GLP. Knowledge of FDA, EMEA and other applicable industry and quality regulations related to pharmaceutical industry is required. Proficiency and knowledge in quality system operations and applicable regulations related to GXP is preferred.

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Quality Control Associate

Immediate opening for Quality Control Associate with hands on, industry experience in running and validating analytical assays such as HPLC, capillary isoelectric focusing, or capillary electrophoresis, preferably in a cGMP or QC environment.

The Quality Control Associate will have a proven ability to troubleshoot and solve problems with assays both during development and routine work. They should have experience in areas such as writing technical reports, stability testing, environmental monitoring, aseptic environment, and instrument calibration.

The successful candidate will have a Master’s degree in Chemistry, Biology, Biomedical, Pharmaceutical Sciences or related field with 1 – 3 years of work experience, or a Bachelor’s degree with 2 – 4 years of work experience, in pharmaceutical or biotech industry analytical laboratories. Quality Control Laboratory experience in support of GMP/GLP strongly preferred.

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Quality Control Associate/Scientist

Immediate opening for Quality Control Associate/Scientist with strong proficiency in developing, optimizing, and validating analytical assays, such as ELISAs, qRT-PCR, or microbiological assays, preferably in a cGMP or QC environment.

The Quality Control Associate/Scientist will have a proven ability to troubleshoot and solve problems with assays both during development and routine work, and extensive experience in several of the following: writing technical reports, validation reports and SOPs, release and stability testing for pharmaceutical products, environmental monitoring, aseptic environment, analytical instrument IQ/OQ/PQ and calibration. The successful candidate will have a PhD in Chemistry, Biology, Biomedical, Pharmaceutical Sciences or related field with 1 – 3 years of work experience, or a Master’s degree with 3+ years of work experience, in pharmaceutical or biotech industry analytical laboratories. Quality Control Laboratory experience in support of GMP/GLP strongly preferred.

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