Senior Associate - Microbiology

PD Senior Associate - Microbiology

Location: Thousand Oaks, CA

Onsite Flexibility: Onsite

Contract Details

• Position Type: Contract
• Contract Duration: 6 months (extension not confirmed)
• Work Authorization: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Job Summary

The Thousand Oaks Cellular Sciences organization is seeking an enthusiastic, highly motivated, and team-oriented individual with a background in microbiology for the position of Process Development Associate within the Process Microbiology Group. The Process Microbiology Group supports the global network by providing scientific and technical expertise for troubleshooting microbiological methods across various analytical platforms, as well as compendial methods and technologies related to microbial control.

The PD Associate will work collaboratively with a team of scientists to execute studies supporting microbiological method development, optimization, and troubleshooting. The role will primarily focus on laboratory execution while also contributing to study design, data analysis, as well as supporting scientists in drafting protocols/summary reports. Activities also include the evaluation of new technologies/rapid microbiology methods (RMM).

The successful candidate will perform studies independently and collaborate with scientists on study execution, support the team on data analysis, and draft protocols/summary reports. In addition, the PD Associate will interface with QC and other cross-functional partners and represent the Process Microbiology team in scientific and technical discussions.

This is a revised, more junior-level role than a previously posted Scientist position. The hiring manager is looking for two hands-on laboratory associates to support the Process Development team. The ideal candidates will have practical laboratory experience and be comfortable working under the direction of scientists, assisting with method development, executing studies, and supporting routine laboratory activities. The manager prefers candidates who can contribute quickly with minimal foundational training, given the short contract duration.

Key Responsibilities

• Work alongside scientists to support method development and laboratory studies
• Execute assigned laboratory experiments and testing activities under scientific guidance
• Assist with study preparation, execution, and documentation
• Execute laboratory studies supporting microbiological method development, optimization, troubleshooting, and validation, including (but not limited to):

- Endotoxin method/low endotoxin recovery (LER) studies - Microbial Challenge/Hold time studies - Bacterial Retention Testing/Sterile Filtration Studies - Advancement of existing methods and implementation of alternative technologies, such as recombinant reagents for endotoxin testing and Monocyte Activation Test (MAT) for pyrogen testing - Evaluation of RMMs

• Analyze and interpret experimental data, summarize study results, and assist with the preparation of protocols, technical assessments, and reports
• Maintain knowledge of current compendial and regulatory requirements applicable to microbiological testing and microbial control, including USP, Ph. Eur., JP, and relevant regulatory guidance (Annex 1, CFRs, etc.)
• Collaborate with QC Microbiology, Process Development, Manufacturing, Quality, and other functions to support the network
• Participate in and represent Process Microbiology in scientific and cross-functional meetings, including communicating study progress, study results, and technical findings
• Communicate effectively and efficiently with cross-functional team members, clients, and partner organizations
• Support day-to-day laboratory operations, including maintaining laboratory supplies and inventory, coordinating ordering of materials, and ensuring appropriate supplies are available to support study execution
• Participate in team meetings and study discussions
• Follow established laboratory procedures and applicable regulatory/compendial requirements

Required Skills

• Hands-on laboratory experience: Prior experience working in a QC, microbiology, process development, or similar laboratory environment; industry experience is strongly preferred
• Method development & study support: Experience assisting scientists with laboratory testing, method development, study execution, and documentation; candidates do not need to have independently led these activities
• Regulatory & compendial knowledge: Familiarity with current compendial standards, laboratory procedures, and applicable regulatory requirements
• Experience in a QC Micro Lab
• Knowledge of compendial methods for Bioburden, Sterility, and Endotoxin (USP/EP/JP)
• Hands-on testing experience

Preferred Skills

• Hands-on experience in microbiology and aseptic techniques
• Prior experience in a microbiological quality lab or similar microbiology laboratory environment
• Demonstrate the ability to understand, apply, and evaluate microbiological principles
• Experience with compendial microbiological methods, including bioburden, bacterial endotoxins, and/or sterility testing
• Detail-oriented with strong laboratory documentation and technical writing skills
• Ability to independently organize and execute laboratory studies while effectively managing multiple priorities and timelines
• Effective written and verbal communication skills with the ability to work independently as well as collaboratively in cross-functional teams
• Proficiency with tools used to organize and manage projects and data, such as SharePoint and Smartsheet

Education Requirements

• Bachelor's degree and 2 years of microbiology or related biological science experience required

Required Experience

• Minimum 2 years of microbiology or related biological science experience

Important Notes

• Non-Negotiables: No QC Microbiology experience or a higher degree with no pharma experience; candidates need to be up and ready to help support testing in a fairly quick time after some initial training
• Interview Process:

1. Initial phone interview 2. On-site interview with the hiring team

Benefits

• Medical, Vision, and Dental Insurance Plans
• 401k Retirement Fund

About GTT

GTT is an NMSDC-certified Minority Business Enterprise (MBE) headquartered in Portsmouth, New Hampshire. GTT is a subsidiary of Chenega Corporation, an Alaska-based company and one of the largest Alaska Native-owned corporations. An Inc. 5000 honoree and one of SIA's Best Staffing Firms to Work For, GTT connects professionals with Fortune 500 organizations across IT, engineering, construction, utilities, life sciences, financial services, and healthcare throughout the U.S. and Canada. We're committed to diverse, inclusive workplaces and to placing people in roles where they can do their best work.

Job Number: 26-18678

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