About this position:
The Quality Control Manager will support the QC operations and work in a laboratory under the direction of QC Director. The candidate will be setting-up, 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 assays, DNA sequencing, endotoxin and 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 management career in biotechnology or the life sciences.
Job description and technical requirements:
- Schedule and manage quality control 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. This will include testing raw materials, in-process samples, finished products; validation, stability, and environmental monitoring samples to ensure conformity to standards and specifications.
- Work with bacteriophages and associated assays (PCR, Elisa, gel electrophoresis, microbiological bioactivity assays, etc.).
- Lead analytical methods validation and stability study projects. Participate in manufacturing process validation studies.
- Prepare and maintain products and reagents for screening assays. Re-stock chemicals and consumables used in analysis.
- Operate, calibrate, troubleshoot, and maintain analytical QC equipment. Assist with 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 Master’s/PhD (preferred) degree in Biochemistry, Microbiology, Biological Sciences, or related field.
- Must have 5 years of GLP/cGMP analytical laboratory experience in industry, with 2 years of quality control management experience (biotech/pharma company).
- Knowledge and compliance to GLP/cGMP, laboratory documentation, safety, and environmental requirements.
- Experience with methods validation, utilizing microbiological, biochemical, spectroscopic and chromatographic analytical techniques. Working knowledge with biological products preferred.
- Preferred experience with manufacturing process validation and Environmental Monitoring testing and procedures.
- 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 the required quality control documentation.
- Time management skills, and ability 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 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. Armata is committed to advancing phage with drug development expertise that spans bench to clinic including in-house phage specific GMP manufacturing.
Armata Pharmaceuticals is an equal opportunity employer. We recognize the importance of a diverse employee population and encourage applicants with various backgrounds and experiences. All qualified applicants will be considered for employment and will not be discriminated against on the basis of race; color; religion; genetic information; national origin; gender; sexual orientation; pregnancy, childbirth, or related medical conditions; familial status; age; disability; military or veteran status; or any other protected class under federal, state, or local law.