Microbiologist III - 2nd Shift

Initial Therapeutics, Inc.; Irvine (CA); On-site; USD 60,614 - 66,124; Full time

Benefits offered by this job

Medical, Dental, Vision

Flexible Spending & HSA Options

Life Insurance

401K

Job summary

Initial Therapeutics, Inc. is looking for a Microbiologist III for the 2nd shift in Irvine, California. The candidate will oversee microbiological testing, manage method qualifications, and ensure compliance with GMP. Responsibilities also include supporting regulatory inspections and training junior staff. Required qualifications include a Bachelor’s degree in Microbiology, 8-10 years of experience in a pharmaceutical microbiology lab, and advanced knowledge of aseptic processing. The position offers a pay range of $44-48/hour plus benefits.

Qualifications

• Advanced hands-on knowledge of pharmaceutical microbiological testing.
• Demonstrated ability to execute microbiological method qualifications independently.
• In-depth understanding of GMP requirements and relevant USP chapters.

Responsibilities

• Perform microbiological testing of raw materials and drug products.
• Manage microbiological method qualifications and validations.
• Support regulatory inspections and audits.

Skills

Pharmaceutical microbiological testing

Aseptic processing principles

Technical problem-solving

Documentation and communication

Organizational skills

Laboratory safety

Education

Bachelor’s degree in Microbiology

8–10 years of pharmaceutical microbiology experience

Tools

LIMS

MS Word

Excel

Job description

"Expect to grow", personally and professionally: At Siegfried, we offer exciting challenges and ample opportunities to showcase your talents. As a trusted and respected partner to the pharmaceutical industry, we uphold the highest standards in safety, quality and sustainability, while fostering a culture that empowers you to thrive. Join a rapidly expanding global company, where diverse perspectives and experiences come together in a collaborative environment. Here, you'll find a workplace that values both collective success and your individual contributions—offering long‑term opportunities to grow and make an impact.

Your Role:

Microbiologist III - 2nd Shift (2:00 PM -10:30 PM)

Responsibilities

1. Independently perform and oversee microbiological testing of raw materials, in-process samples, utilities, and finished drug products, including but not limited to bioburden, sterility, endotoxins, microbial limits testing, growth promotion, BI enumeration, bacterial suspension preparation, sub‑visible particulates, AET, and CCIT.
2. Execute, author, and manage microbiological method qualifications and validations in accordance with USP, compendial requirements, internal SOPs, and regulatory expectations.
3. Serve as a technical SME for aseptic processing support, including environmental monitoring (viable and non‑viable), utilities monitoring (WFI, HPW, clean steam), and cleanroom behavior.
4. Provide hands‑on support for aseptic operations, media fills, personnel monitoring, aseptic gowning qualification, and on‑the‑floor microbiology support as needed.
5. Analyze, trend, and interpret environmental monitoring and microbiological data; identify adverse trends and support investigations, impact assessments, and CAPAs.
6. Support and author microbiology‑related protocols, reports, deviations, investigations, and technical justifications.
7. Participate in and support regulatory inspections, customer audits, and internal audits as a microbiology technical representative.
8. Collaborate cross‑functionally with QA, Manufacturing, MSAT, Engineering, Facilities, Validation, and external partners to support new product introductions, process changes, and continuous improvement initiatives.
9. Ensure all microbiology laboratory activities are performed in compliance with GMP/GDP requirements and that all equipment used is properly qualified, calibrated, and maintained.
10. Maintain accurate, contemporaneous documentation in laboratory notebooks, controlled forms, and electronic systems (e.g., LIMS).
11. Support training, mentoring, and technical development of junior microbiology staff through knowledge sharing, technical leadership, and hands‑on guidance. Acts as a go‑to technical resource for complex microbiology and aseptic processing questions.
12. Maintain laboratory areas in a clean, organized, and inspection‑ready state; support laboratory operations activities as needed (media prep, autoclave use, chart changes, inventory support).
13. Demonstrate a strong team‑oriented mindset with a willingness to roll up sleeves and execute laboratory and manufacturing‑support work as priorities require.
14. Perform all other duties as assigned by the immediate supervisor.

Required Knowledge, Skills and Abilities

• Advanced hands‑on knowledge of pharmaceutical microbiological testing and aseptic processing principles.
• Demonstrated ability to independently execute microbiological method qualifications and validations without direct supervision.
• Strong technical problem‑solving skills and ability to troubleshoot complex microbiological and aseptic issues.
• In‑depth understanding of GMP requirements and relevant USP chapters applicable to microbiology and sterile manufacturing.
• Excellent written and verbal communication skills, with the ability to clearly document and explain technical concepts.
• Proven ability to work effectively in a cross‑functional, fast‑paced manufacturing environment.
• Strong organizational skills with the ability to manage multiple priorities simultaneously.
• Hands‑on, proactive, and collaborative team player with a strong work ethic.
• Proficient in standard computer applications (MS Word, Excel) and laboratory systems (e.g., LIMS); ability to quickly learn new systems.
• Knowledge of laboratory safety requirements and aseptic gowning practices.

Required Education and Experience

• Bachelor’s degree in Microbiology or a closely related scientific discipline (advanced degree preferred).
• Minimum of 8–10 years of experience in a pharmaceutical microbiology laboratory supporting sterile drug product manufacturing.
• Demonstrated experience executing microbiological method validation/qualification and providing direct aseptic operations support.
• GMP pharmaceutical experience required; experience supporting regulatory inspections strongly preferred.
• Candidates with a non‑Microbiology scientific degree and significant directly relevant microbiology experience will be considered.

Target Pay Range: $44-48/hour + 2nd Shift 10% Differential

Individual compensation packages are based on various factors unique to each candidate, including skill set, experience, qualifications and other job‑related reasons.

Your Benefits:

• Medical, Dental, Vision
• Flexible Spending & HSA Options
• Life Insurance, Short & Long Term Disability
• Pet Insurance
• 401K

Founded in 1873 in Zofingen, Switzerland, Siegfried has grown into a global network of 13 sites across three continents. With a team of more than 3,800 highly skilled professionals, we take the innovations of our pharmaceutical customers to industrial scale and manufacture safe drugs for patients worldwide. As a fully integrated CDMO, Siegfried is one of the few organizations today that can carry out the development and manufacturing of APIs and finished dosage forms under one roof. This unique combination of know‑how and experience makes us the most trusted partner in the pharmaceutical industry.