Manager, Microbiology

CSBio is a peptide contract manufacturing founded in 1993. Our initial products were a complete line of automated synthesizers for manufacturing and process development, with a focus on cGMP production. In 1994, we opened our custom peptide facility and began producing high quality compounds for research organizations and pharmaceutical companies worldwide. In 2004, we opened our peptide production facility in Menlo Park, CA and in 2014, we expanded our production capability through the addition of a new, state of the art building dedicated to cGMP peptide production. In 2017, we passed a FDA inspection and were recommended to be approved for commercial drug substance manufacturing. In 2023, we added additional cGMP clinical production capacity in Milpitas, CA.

You will be employee #1 for the new microbiology unit at CSBio.

Job Duties:

• Lead and manage microbiology and EM programs, including sampling, data review, investigations, and trending for GMP production areas
• Direct sterility assurance programs, including oversight of cleanroom classifications, gowning, and microbial controls
• Supervise microbiology team members, providing coaching, training, and performance management
• Develop, review, and approve SOPs, protocols, specifications, validation reports, and change controls related to microbiology and EM activities
• Lead investigations related to EM excursions, contamination events, and microbiological OOS results; perform root cause analysis and implement CAPAs
• Oversee the qualification of microbiological methods, growth promotion testing, and equipment validation
• Represent Microbiology as the Subject Matter Expert (SME) in audits, inspections, and cross-functional project teams
• Ensure compliance with cGMP, FDA, ICH Q9/Q10, and internal quality standards
• Drive continuous improvement in microbiology and EM systems through the implementation of industry best practices and risk-based approaches
• Work with Operations, Manufacturing, Quality Control, and Validation to establish, develop, communicate, and maintain a validation assessment plan for all GXP assets, buildings, systems, including laboratory instrumentation and systems
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
• Manage the recall process including initiation, customer and regulatory notification, and product withdrawal
• Identify and manage continuous improvement projects with the objective of achieving quality and efficiency in processes
• Manage, develop and mentor staff
  
  

Competencies:

• To perform the job successfully, an individual should demonstrate the following competencies:
• Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations.
• Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Supports everyone's efforts to succeed.
• Organizational Support - Follows policies and procedures; Completes tasks correctly and on time; Supports organization goals and values
• Motivation - Sets and achieves challenging goals; Demonstrates persistence and overcomes obstacles; Measures self against standard of excellence
• Adaptability - Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events
  
  

Requirements

• Bachelor's degree (B.S.) in Microbiology, Biology, or a related scientific discipline. An advanced degree is preferred
• Minimum of 5 years of relevant industry experience, with at least 2 years in a leadership or supervisory role in microbiology/EM within a GMP regulated environment
• Extensive knowledge of aseptic techniques, sterility assurance, and pharmaceutical manufacturing requirements
• Experience in environmental monitoring of ISO 5 - 8 cleanrooms, utilities (WFI, CDA, Nitrogen), and process simulation testing
• Demonstrated expertise with regulatory compliance (21 CFR 210/211) and quality systems
• Strong analytical, technical writing, organizational, and interpersonal skills
• Proficiency in statistical/data trending tools is a plus
• Strong GMP knowledge and in depth understanding of ICH and FDA regulations
• Thorough understanding of problem-solving and quality improvement tools and techniques
• Ability to work effectively and collaboratively in a cross-functional team within a fast-paced environment
  
  

Benefits

• Medical, dental, and vision insurance (Kaiser HMO or BlueShield PPO. Employer pays 85% for Employee and 50% for Employee's family; Dental: Aetna Dental, Delta Dental, Guardian Dental, MetLife Dental. Vision: VSP and Aetna EyeMed)
• 401k 10% 1:1 match
• Companywide paid holiday during: Week of July 4, Thanksgiving (2 days), Week of December 25
• PTO policy. 10 days PTO
• Basic life ($20,000 paid by company) and supplemental life insurance (optional supplemental)
• Disability insurance 50% standard employer paid
• Carpool, clean air vehicle, and cell phone reimbursement
• Employee rewards and recognition program
• Company organized social events
• Quarterly sponsored team building activities