Specialist, 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.

Why Theragent?

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.

Our Mission:

To Manufacture and Deliver high-quality, reliable, and value-added Therapeutic Solutions for Biopharma clients and patients.

Position Summary:

The QC Microbiology Lab Specialist 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 QC Microbiology Lab Specialist will assist in the method transfer and validation studies, support commissioning new equipment, support revising and editing Quality system procedures, assist continuous improvement initiatives, and support QC on project teams for clinical and commercial products. Working with QA, manufacturing, and analytical development groups, the QC Microbiology Specialist will be responsible for meeting QC timelines related to deliverables such as method transfer reports, test methods, change controls, and validation protocols and reports.

The QC Microbiology Lab Specialist will assist and support 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.

Primary Responsibilities:

• Assist the transfer and validation of test methods in support of drug substance release and stability testing. Revise test methods, validation protocols and reports, Quality system SOPs, and other supporting documents. Support equipment onboarding and validation lifecycle, including operation and maintenance procedures and software systems. Assist initiating change controls, support investigations, CAPAs, and continuous improvement initiatives to successful completion. Represent QC Microbiology on project teams for clinical and commercial products with primary responsibility for validation of Drug Substance release assays. Support performing validation of microbiological assays and assist provide training related to in-process and drug substance testing, equipment, environmental and utility monitoring to include Bioburden, Endotoxin, Growth Promotion testing, etc. Assist and support to perform 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 and support to perform 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. Assist to perform microbial identification like gram stains, gene sequencing. Track all data and complete in a timely manner. Perform all activities in compliance with cGMP regulations. Assist preparation and presentation of quarterly and annual reports, trend investigations, statements of quality, and other applicable reports to management. Support onboarding and qualification of laboratory equipment and GMP software systems.
• Generate and write SOPs and protocols related to test methods involving product lot release.
• Draft technical documents including test methods, validation documents, and deviations.
• Assist implementation of change controls, support investigations, and complete CAPAs in support of GMP operations. Assist in purchasing all necessary supplies, needed for QC Microbiology. Assist to receive supplies, log-in and store appropriately following written procedures. Assist to perform 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 in a timely manner and support finding creative solutions to resolve them. 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. Assist creating training materials and training staff on methods and related SOPs. Support implementation and qualification of current and new pharmacopoeia methods to ensure compliance with cGMP’s and other regulatory requirements. Assist analyzing and summarizing data into reports and certificates of analysis with attention to details. Participate in risk assessments such as HAZOP’s and FMEA’s. Assist proposing corrective and preventive actions and improvements identified through investigations and audits and assist performing effectiveness checks of CAPA’s. Perform sample management tasks, including labeling, shipping to external labs, inventory, and disposal of samples. Participate in collaboration meetings with external clients, contractors, and vendors. Participate in internal audits and external audits and support providing responses and implementation of actions related to observations. Other duties as assigned by management.

Knowledge, Skills & Abilities:

• Demonstrated in-depth knowledge of Microbiological methods across a wide range of technologies. Proven scientific and technical ability to design and execute method development and validation experiments; analyze and present data; author and review protocol and reports, in support of regulatory submissions. Demonstrated deep knowledge and experience of cGMP and the regulatory requirements for pharmaceuticals. Must be a highly motivated and self-driven individual with the ability to work independently, and multi-task under aggressive timelines to support department and business objectives Very good analytical, technical writing, communication, and data management skills Demonstrated expertise with a range of Microbiological test methods including Bioburden, Endotoxin, Environmental and Critical Utility Monitoring, Growth Promotion, Water analysis. Knowledge of cGMP, ICH, pharmacopoeia, and regulatory requirements for testing and validation pertaining to the pharmaceutical industry is required. Experience in the qualification of cell therapy equipment a plus Knowledge of pharmaceutical, manufacturing and laboratory systems and equipment Working knowledge of Deviations, Change Controls, and CAPAs Strong written and verbal communication skills Very 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

Competencies:

• Strong communication skills in small and large group settings Strong team player, able to meet deadlines and changing priorities Strong Organizational and Time Management Skills Understanding of cGMP regulations, preferably with Cell Therapy

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 5 years of work experience in the Pharmaceutical, Life Sciences industry with cGMP, GLP A strong background in method development, qualification and validation is highly desired.  A background in quality control testing related to Biopharmaceuticals is required. Experience with problem solving methods such as DMAIC or other similar Root Cause Analysis Tools Strong knowledge of cGMP and ICH guidelines. Other regulatory agencies experiences preferred Basic knowledge of Compendial (i.e., USP, EP, JP, etc.) requirements and standards Experience with electronic Laboratory Information Management Systems (LIMS) Strong understanding of Microbiology related to drug substance or drug product manufacturing. Experience with relevant microbiology laboratory equipment and software.

Working Conditions:

• 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

Environmental Conditions:

• 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

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.