Scientist #26-18867

Us Tech Solutions; Thousand Oaks (CA); Hybrid; USD 52,000 - 56,000; Full time

Job summary

US Tech Solutions is seeking a Scientist to support microbiology methods in a biotech/pharma setting. The role involves validating rapid microbiology methods, endotoxin, bioburden, sterility, and collaboration with Process Development, Manufacturing, and Quality.

You will work in a lab environment, perform feasibility and validation studies, and contribute to cross-functional programs across locations. A Doctorate or relevant Master/Bachelor with years of experience is preferred.

Qualifications

• Experience in QC Microbiology Lab.
• Knowledgeable on regulations (FDA CFRs, EMA Annex 1, Pharmacopeias).
• Experience in troubleshooting methods (endotoxin/LER) and sterile filter validation.

Responsibilities

• Validate/execute studies to support QC labs (e.g., rapid micro methods, LER troubleshooting).
• Develop/execute sterile filter validations.
• Attend meetings with QC and regulatory teams.
• Review regulation and pharmacopeia changes and assess impact on protocols/reports.
• Provide micro method scientific support as needed.

Skills

QC Microbiology Lab

Regulatory knowledge

Sterile filter validation

Troubleshooting methods

Education

Doctorate Degree

Master's degree + 4 years

Bachelor's degree + 6 years

Job description

$38.00-$40.70 per hour

Thousand Oaks, CA

Contract

Duration: 6-month contract

Shift: Dayshift 8 - 5 PM

Hybrid set up: All candidates must be willing to work 5 days onsite when needed but can also be a remote depending on the schedule or agreement with the hiring manager.

Job Description:

• Scientist will support microbiology related methods such as, endotoxin, bioburden, sterility and other compendial methods associated with microbial control.

• Hands on laboratory work include method troubleshooting, and involvement in evaluating new technologies related to rapid microbiology methods, including developing and executing feasibility and/or validation studies.

• The candidate will require to work in the laboratory to support feasibility and/or validation studies (time spent in lab varies depending on projects).

• Experience in pharmaceutical/biotechnology microbiology and manufacturing are preferred.

• The candidate would be a part of a team that supports various microbiology methods in various stages of the product life cycle.

• This team supports programs/methods at locations throughout the company.

• The Scientist collaborates with representatives from key functions within Process Development, Manufacturing, and Quality.

• Ideal candidate: Candidates that have industry experience in biopharmaceutical manufacturing.

Day to day responsibilities:

• Candidate will work on validations/studies to support QC labs as needed (e.g., rapid micro methods, LER troubleshooting).

• Help develop/execute sterile filter validations internally.

• Attend meetings with QC.

• Assist in reviewing regulation and pharmacopeia changes and determine overall impact, as well as protocols/summary reports executed by contract testing labs.

• Provide micro method technical support as needed.

Basic Qualifications:

• Doctorate Degree OR

• Master’s Degree and 4 years of Scientific Experience OR

• Bachelor’s degree and 6 years of Scientific experience

Preferred Qualifications:

• Prior experience in Microbiological Quality at the technical level, including experience with sterile filtration validations

• Advanced understanding and hands-on experience in various analytical platform such as compendial microbial methods, rapid methods for microbial detection/identification and advanced technologies for detection of bacteria

• Excellent written and oral communication skills for the timely documentation, presentation and discussion of scientific results in a fast-paced, multi-disciplinary, team-based environment.

• Advanced ability to critically analyze and interrogate various analytical data sets (e.g. complex dilution schemes) to drive and influence the investigational process

• Advanced root cause analysis capabilities including leading advanced and complex events

• Advanced ability to propose and lead new scientific imperatives/initiatives

• Expert in an investigational laboratory setting within a pharmaceutical or biotechnology company

• Advanced experience in working closely with scientific and manufacturing disciplines across process development, clinical, and commercial operations

• Familiarity with cGMP regulations, FDA and EU regulations and guidelines

Top must have skills:

• Experience in QC Microbiology Lab.

• Knowledgeable on regulations (FDA CFRs, EMA Annex 1, Pharmacopeias).

• Experience in troubleshooting methods (endotoxin/LER) and sterile filter validation.

About US Tech Solutions:

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com .

"US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran"

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