Sr. Scientist I - Microbiology

Responsibilities

• Supports aseptic manufacturing or clean room ISO100 operations.
• Performs more complex microbial analysis and assists in method development and validation.
• Troubleshoots and trains on individual core technologies.
• Trains others on individual core technologies.
• Interacts with clients.
• Serves as a primary technical contact with clients.
• Initiates procedural revisions and performs editing and review functions.
• Participates actively in lab investigations and corrective and preventative actions.
• Participates in process improvements.
• Participates in company training and maintains current status of certifications.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Provides technical training and leadership for subordinate technical positions.
• Maintains a safe, clean, and organized work environment free from safety hazards.

Qualifications

• Bachelor’s degree in Biology, Microbiology, or related field with 8+ years of experience, a master’s degree with 4+ years of experience or a PhD with 2+ years of experience is required.
• Prior pharmaceutical or CDMO experience required.
• Knowledge, Skills, And Abilities:
• Proficiency in any or all of the following: USP, , , (Microbial Examination), USP (Biological Indicators), USP (Methods for Determination of Resistance of Microorganisms to Sterilization), USP (Bacterial Endotoxins Testing), Growth Promotion of Media, – required.
• Understanding of USP (Sterility Testing using an isolator), USP Particulate Matter in Injections.
• Ability to perform lab investigations, microbial risk assessments, and corrective and preventative actions a plus.
• Excellent verbal and written communication and documentation skills required.
• Excellent detail orientation and organizational skills required.
• Excellent problem-solving and basic trouble-shooting ability required.
• Excellent knowledge of Laboratory equipment and safety required.
• Excellent knowledge of Laboratory Documentation is required.
• Strong knowledge of cGMP in a pharmaceutical or regulated environment preferred.
• Proficiency with Microsoft Office (Word, Excel, PowerPoint) required.

On-Site Expectations

• 100% on-site position.
• 1st Shift: Monday - Friday, 8:00am - 5:30pm.