PURPOSE OF JOB
This position performs assessment of materials, documentation, and testing in a GMP environment with the potential to help optimize, qualify, and validate analytical methods for routine and non-routine QC analysis of finished formulations, in-process samples, and raw materials in compliance with FDA/cGMP/GLP regulations and all operational procedures.
Positions Description
- Assist with implementing new methodologies and instrumentation, writing SOPs, preparing and executing qualification protocols and reports, vial inspection, and technical transfer of assays to the QC laboratory.
- Follow good documentation practices in all aspects and phases of the work.
- Provide data, results, summaries, and reports for review in a timely manner
- Work with other lab personnel on projects and participate in OOS and failure investigations.
- Help maintain the equipment, safety, and the orderliness of the lab.
- Cross-train to provide support to internal teams such as environmental monitoring (EM) and analytical development.
- Other duties as assigned.
JOB REQUIREMENTS
- A BS degree with 6 years or MS degree with 3 years of applicable experience and demonstrated working knowledge of analysis of proteins, nucleic acids, microbes, and / or viruses in a laboratory environment as pertains to GMP Quality Control.
- Hands-on experience with the following methods using basic and specialized laboratory equipment and software: Bioburden, endotoxin, cell culture, polymerase chain reaction (PCR), spectrophotometry, SDS-PAGE, Western blot, pH, conductivity, TOC, ELISA or comparable ligand-binding chemistry.
- Experience with cGMP and quality system operations including OOS investigations, deviations, compliance events, change control, and CAPAs.
- Excellent oral and written interpersonal communication skills.
- High attention to detail, excellent organizational skills and the ability to work on multiple projects with tight deadlines.
- Demonstrated ability to work independently as well as be a strong contributor on complex projects in a cross-functional team environment.
- Proven and demonstrated computer (PC) and software skills including instrument software, MS Office Suite programs, Internet, email systems.
- Must be able to lift up to 50 lbs with or without reasonable accommodations
- Must meet the pre-employment physical requirements including drug screen, background, credit and reference checks
Advanced BioScience Laboratories (ABL) is a biotech corporation with headquarters located in Rockville, MD providing contract manufacturing and laboratory research services to advance leading vaccines and therapies from clinical development to the commercial market. ABL has been around for nearly 60 years, has three locations (one domestic and two in Europe), and is part of the Institut Mérieux family.
ABL harnesses decades of pioneering science and manufacturing expertise to drive the development of innovative therapies and vaccines supporting the biopharmaceutical industry in their quest to improve public health. Come join us in empowering people to conquer the world’s most challenging diseases.
Why Work With ABL?
ABL offers good benefits, flexibility, a generous PTO and 401k match and contribution, tuition assistance, wellness program, and referral program (visit our website to see more! https://ablinc.com/). We have deep roots and are working on many changes to improve and expand our service to our customer. There are opportunities to get involved and create!
ABL, Inc. does not accept nor respond to unsolicited resumes from vendors, including recruitment agencies and search firms. Approved recruiting agencies must obtain prior approval from ABL, Inc. Human Resources in order to submit resumes to ABL, Inc. for consideration.
Job Type: Full-time
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Employee discount
- Flexible spending account
- Health insurance
- Life insurance
- Paid time off
- Parental leave
- Professional development assistance
- Referral program
- Retirement plan
- Tuition reimbursement
- Vision insurance
Schedule:
COVID-19 considerations:
COVID-19 precautions
- Remote interview process
- Personal protective equipment provided or required
- Temperature screenings
- Social distancing guidelines in place
- Virtual meetings
- Sanitizing, disinfecting, or cleaning procedures in place
Education:
Experience:
Work Location:
Work Location: One location