Senior Quality Control Associate
About this Position:
The Senior Quality Control (QC) Associate will support the QC operations and work in a laboratory under the direction of QC management. The candidate will be setting-up, fine-tuning, validating and executing assays for analysis, stability, and release of raw materials and biological products such as bacteriophages. The position will involve working with PCR, Elisa, Gel electrophoresis, DNA/RNA and potency/titer, DNA sequencing, endotoxin and bioburden/sterility assays, chromatography/ spectroscopy instrumentation (e.g. HPLC, LC-MS, high-throughput automated fluorescence and luminescence systems), as well as variety of chemical and micro-biological assays, and reporting results. The candidate will interact with R&D, production, quality, and technical teams, as well as contract labs on analytical testing projects. This is a superb opportunity for candidates considering a quality control career in biotechnology or the life sciences.
Job description and technical requirements:
- Perform assigned testing in a timely and organized manner in compliance with the applicable GLP, cGMP, safety and environmental regulations, as well as company policies and procedures. Test raw materials, in-process samples, finished products; validation and stability samples to ensure conformity to standards and specifications.
- Work with bacteriophages and associated assays (PCR, Elisa, gel electrophoresis, microbiological bioactivity assays, etc.).
- Assist with analytical methods validation and stability study projects
- Prepare and maintain products and reagents for screening assays. Re-stock chemicals and consumables used in analysis.
- Operate, calibrate, troubleshoot, and maintain analytical equipment. Assist in equipment validations (IQ, OQ, PQ, and MQ)
- Write Standard Operating Procedures (SOPs), analytical technical reports, method validation and stability protocols and reports. Conduct literature search to identify suitable methods
- Maintain organized, accurate and complete laboratory notebooks and records
- Process, analyze and organize large data sets
- Assist in general upkeep of laboratory and maintain a clean work environment
- Other duties as assigned
Qualifications and Experience:
- Must have a Bachelor’s or MS/PhD (preferred) degree in Biochemistry, Microbiology, Biological Sciences, or related field
- Must have 3 years of GLP/cGMP analytical laboratory experience in industry (biotech/pharma company). Genome sequencing, informatics and analytical methods validation experience preferred.
- Knowledge and compliance to GLP/cGMP, laboratory documentation, safety and environmental requirements
- Experience at minimum utilizing microbiological, biochemical, spectroscopic and chromatographic analytical techniques. Working knowledge with biological products
- Able to troubleshoot and solve problems encountered with methods and instrumentation
- Experience with Microsoft Office products (proficiency with Excel) and working knowledge of chromatography and spectroscopy instrument software. Able to understand statistics and statistical software to interpret experimental results
- Advance level of written and verbal communication skills with ability to read technical procedures or governmental regulations and guidelines. Able to write reports, and required quality control documentation.
- Time management skills and able to perform multiple tasks.
- Must be reliable, detail oriented, and collaborative, with the ability to organize and prioritize tasks/projects
- Support quality and continuous improvement processes. Willing for continued education, training or certification in quality control laboratory skills for fulfilling the assigned duties, as necessary.
- Excellent English communication and reading skills
- Excellent interpersonal and communication skills to effectively work within a team environment
- Self-starter and quick-learner. Ability to work under minimal supervision
Physical Working Conditions:
This is a full– time position for work in a laboratory environment. The position requires wearing personal protective equipment. Occasionally, may require lifting or moving equipment up to 20 pounds and may require standing for extended durations throughout the day. Upon request, reasonable accommodations will be offered to enable individuals with disabilities to perform essential functions. There is little to no travel required of this position, with the exception of required training and possible conference or event attendance.
About Armata Pharmaceuticals, Inc.:
Armata is a clinical-stage biotechnology company focused on the development of precisely targeted bacteriophage therapeutics for the treatment of antibiotic-resistant and difficult-to-treat bacterial infections using its proprietary bacteriophage-based technology. Armata is developing and advancing a broad pipeline of natural and synthetic phage candidates, including clinical candidates for Pseudomonas aeruginosa, Staphylococcus aureus, and other pathogens. In addition, in collaboration with Merck, known as MSD outside of the United States and Canada, Armata is developing proprietary synthetic phage candidates to target an undisclosed infectious disease agent. Armata is committed to advancing phage with drug development expertise that spans bench to clinic including in-house phage specific GMP manufacturing.
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