Associate, QC Micro
What We Do
Theragent is a privately-owned Contract Development and Manufacturing Organization (CDMO) focused on novel Cell and Gene Therapy medicines to meet unmet patient needs. We are a small, biotech startup headquartered in Arcadia, CA. Our state-of-the-art facility provide high-quality, reliable, and value-added solutions to our clientele for challenging pre-clinical and clinical trial projects. Our innovative cGMP facility offers comprehensive end-to-end manufacturing and testing capabilities for clinical and commercial purposes.
Take the next step in your career and join Theragent today to change patient lives through the products we help develop and manufacture. Here, you will contribute your talents in a purposeful way that impact the lives of patients around the world. You will develop as an individual by working directly with a team of seasoned experts and rising stars. Our values of Innovation, Transparency, Accountability, Integrity, Diversity, Humility to name a few are embedded in everything we do. No matter your role may be, Theragent strives to ensure all our teammates are empowered and given the necessary tools to lead us in our relentless pursuit to extending patient lives.
To Manufacture and Deliver high-quality, reliable, and value-added Therapeutic Solutions for Biopharma clients and patients.
The Associate, QC Micro has a unique opportunity to play a key role in building of the QC Microbiology laboratory from ground up for a Cell and Gene therapy biotech startup. The Associate, QC Micro will be responsible for participating in the day-to-day operation of cGMP compliant Quality Control Microbiology laboratory of Theragent Inc to include performing and providing support for functional aspects of the facility such as environmental and utility monitoring (EM), microbiological testing, media fills, water testing, and other activities that will support execution of testing for cGMP samples for in-process, lot release and stability samples in-house. This role will be responsible for documentation that is compliant with all applicable procedures, standards, and cGMP regulations. The QC Microbiology Laboratory is a highly controlled environment, where significant attention must be paid to written procedures, safety, and cGMP compliance. Schedules and completing testing on time error free are of paramount importance. The lab is equipped with highly sensitive and expensive instruments which must be handled with care.
- Assist in performing environmental and utility monitoring of the cell and gene therapy production facility according to written procedures while fully gowned including operational monitoring and personnel monitoring during aseptic processing, and aseptic filling.
- Assist performing routine environmental monitoring, as needed to meet schedules.
- Read environmental and utility monitoring plates by counting microbial colonies.
- Fill out appropriate reports and forms contemporaneously.
- Perform microbial identification like gram stains, gene sequencing.
- Document all data contemporaneously and complete in a timely manner.
- Perform all activities in compliance with cGMP regulations.
- Perform other microbiology assays, including bioburden, endotoxin, etc as assigned by management.
- This position will compile all data to support preparation of quarterly and annual reports, trend investigations, statements of quality, and other applicable reports.
- Support onboarding and qualification of laboratory equipment and GMP software systems.
- Assist in purchasing all necessary supplies, needed for QC Microbiology.
- Support receiving supplies, log-in and store appropriately following written procedures.
- Assist performing growth promotion analyses on all microbiological media lots received.
- Report results on appropriate forms.
- Inspect and clean the laboratory and its equipment on a regular basis.
- Perform laboratory and equipment cleaning, preventative maintenance and calibration as described in written procedures.
- Follow written procedures for cleaning.
- Record all necessary information and maintain current, accurate, legible records of all work performed.
- Report problems to management.
- Ensure compliance to all quality requirements to meet audit standards and regulatory compliance.
- Maintain lab equipment, reagents inventory, and documentation to ensure accurate, timely, and cost-effective analysis of materials and products.
- Implements, and qualifies current and new pharmacopoeia methods to ensure compliance with cGMP’s and other regulatory requirements.
- Compile data into reports accurately.
- Support performing sample management tasks, including labeling, shipping to external labs, inventory, and disposal of samples.
- Other duties as assigned by management.
Reports to: QC Microbiology Lead
FLSA Status: non-exempt
Location: Arcadia, CA
Knowledge, Skills & Abilities:
- Knowledge of cGMP, ICH, pharmacopoeia, and regulatory requirements for testing pertaining to the pharmaceutical industry is required.
- Other regulatory agencies experiences preferred.
- Knowledge of pharmaceutical, manufacturing and laboratory systems and equipment.
- Basic knowledge of Compendial (i.e., USP, EP, JP, etc.) requirements and standards.
- Strong understanding of Microbiology related to drug substance or drug product manufacturing.
- Strong written and verbal communication skills.
- Good interpersonal and teamwork skills with experience dealing with all levels within the company.
- Willingness to collaborate internally and with clients while following regulations.
- Strong multi‐tasking ability in conjunction with proven organizational and record keeping skills.
- Ability to organize assigned tasks in a high paced environment and monitor tasks / assignments that may impact timely completion.
- Ability to effectively manage multiple tasks and activities simultaneously.
- Proficient computer skills in Microsoft Office Suite – Word, Excel, PowerPoint, and Outlook.
- Innate ability to learn new software, such as corporate intranet and enterprise business.
- Strong team player, able to meet deadlines and changing priorities.
Education & Professional Experience:
- Bachelor’s degree in Microbiology, Molecular and Cell biology, Biology or related field required. In lieu of this requirement, work experience may be considered.
- Minimum of 2 years of work experience in the Pharmaceutical, Life Sciences industry with cGMP, GLP.
- Experience with relevant microbiology laboratory equipment and software.
- Laboratory environment. Must wear PPE due to safety requirements in designated lab areas.
- May be required to work in controlled or clean room environments.
- Must be able to read, write, and converse in English.
Travel: Occasional. Less than 10%
Physical / Mental Demands:
- Occasional stooping, bending, stretching, pushing, pulling, reaching and/or lifting up to 25lbs.
- Ability to sit, stand, walk, and move within workspace for extended periods.
- Ability to perform repetitive tasks including hand to finger manipulations, grasping, pushing, and pulling.
- Primarily GMP process clean room environment but will be required to enter laboratory areas donning proper gowning / lab coats or PPE such as safety glasses, gloves, face masks and shoes.
- Ability to work safely and effectively when working alone or working with others.
This description outlines the basic responsibilities and requirements for the position noted. This is not a comprehensive listing of all job duties of position. Duties, responsibilities, and activities may change at any time with or without notice.
Theragent, Inc. is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status, and veteran status. All qualified applicants will receive consideration for employment.
Theragent, Inc. requires employees to be vaccinated against COVID-19. To the extent permitted by applicable law, candidate must be able to provide proof of full vaccination or receipt of the first dose of a two-dose COVID-19 vaccine, or request an exemption due to a medical reason, a sincerely held religious belief of practice, or pregnancy, as of the first day of work, to be considered for a U.S.-based job.