Senior Associate Scientist, Quality Control- Microbiology (Small Molecule)

Role Summary

The QC Microbiology Senior Associate Scientist provides strategic leadership and oversight of daily microbiological operations within Global Quality Control for small molecules and biologics. The role contributes to monitoring QC test method execution and microbiological lifecycle management, and refining QC procedures to ensure global cGMP compliance. It also involves managing clinical and commercial microbiological sample shipping and testing logistics and data entry from CTLs/CMOs into the LIMS.

Responsibilities

• Experience with Small Molecules Quality Control microbiology and extensive knowledge of industry best practices and trends.
• In-depth understanding and application of GMP principles, concepts, practices and standards in the US and internationally.
• Must be able to develop and improve complex concepts, techniques, and standards and new applications based on quality principles and theories.
• Must be able to develop solutions to complex problems, which require a high degree of ingenuity, creativity and innovativeness.
• Must be able to exercise judgment and independently determine and take appropriate action where precedent may not exist.
• Proven ability to work with senior management to develop and ensure the implementation of Company-wide long-term solutions.
• Demonstrated an ability to develop a vision for Quality Control functions and have shaped the capabilities of the function to fulfill that vision.
• Demonstrated the ability to influence process and outcomes across functions.
• Willing to support future laboratory work.

Qualifications

• Required: Master's Degree in Chemistry, Biochemistry or related field and 3+ years of relevant experience
• Required: Bachelor's Degree in Chemistry, Biochemistry or related field and 5+ years of relevant experience
• Required: Associate’s Degree in Chemistry, Biochemistry or related field and 7+ years of relevant experience
• Required: High School Degree and 9+ years of relevant experience
• Preferred: 2+ years of relevant experience in a Microbiology Lab environment, including knowledge of microbiological testing, experience with aseptic processing, including sterile liquid handling and manipulation, familiarity with microbiology laboratory instrumentation and environmental monitoring.
• Preferred: Deep knowledge and experience in Biopharmaceutical or Pharmaceutical quality control. Stays ahead of shifting microbiological trends in industry.
• Preferred: Knowledge and experience in Small Molecule Oral Solid Dose and Sterile Small Molecule manufacturing.
• Preferred: Must think critically and creatively and be able to work independently to determine appropriate resources for resolution of problems.
• Preferred: Strong organizational and planning skills.
• Preferred: Shows excellent verbal and written communication skills and collaborative interpersonal skills.