Analysis Skills, Artificial Intelligence (AI), Automation, Best Practices, Biology, Biotech and Pharmaceutical, Budget Management, Budgeting, Capital Budgeting, Career Development, Competitive Analysis/Strategy, Continuous Improvement, Contract Research Organization (CRO), Cost Control, Cross-Functional, Customer Support/Service, Data Quality, Design Verification, Environmental Monitoring, Establish Priorities, Experiment Design, Feasibility Analysis, Functional Programming Languages, GLP (Good Laboratory Practices), GMP (Good Manufacturing Practices), Genetics, Groundskeeping, Health Insurance, Healthcare, Inventory Management, Inventory Planning, Laboratory Management, Laboratory Operations, Laboratory Techniques, Leadership, Legal, Machine Learning, Maintain Compliance, Manufacturing, Manufacturing Operations, Market Research, Medical Equipment, Medical Products, Mentoring, Microbiology, Multimedia, Operational Strategy, Operations Management, Patient Care, People Management, Performance Management, Personal Care, Process Improvement, Product Demonstration, Product Development, Product Lifecycle, Product Management, Product Programs, Product Support, Quality Control, Regulatory Compliance, Regulatory Submissions, Requirements Management, Research & Development (R&D), Risk, Risk Analysis, Robotics, Root Cause Analysis, Safety Compliance, Sales, Sales Strategy, Statistics, Stewardship, Strategic Accounts, Talent Management, Technical Leadership, Technical Presentation, Technical Strategy, Testing, Validation Plan
Director Microbiology
Lexington, MA
Operations - Microbiology - 3040 FTE Exempt - REG Hybrid
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Winning the race to bring new healthcare products safely to a waiting world drives Rapid Micro Biosystems (RMB) to combine todays innovative technologies as never before. Your career at RMB puts you at the center of diverse global teams that span robotics, AI, Machine Learning, imaging, microbiology, and more, re-shaping how urgently needed pharmaceuticals are made, tested, and released for decades to come. The skys the limit.
Careers at RMB are fast-moving with the high growth youd expect from a world leader in microbiology automation. Advancement at RMB affords an opportunity to achieve your personal goals and develop your passions in an inclusive environment where every employee has the resources and opportunities to hone their skills. Youll do more, learn more, and have the ability to make a profound impact on our business.
The Director Microbiology provides strategic and operational leadership for microbiology research, new product development (NPD), and applications services supporting the Growth Direct System and its applications.
This role is responsible for leading microbiology-driven innovation, overseeing laboratory operations, directing technical strategy for product development programs, and serving as a pharmaceutical microbiology subject matter expert (SME).
The position partners cross-functionally with Engineering, Product Management, Operations, Quality, and Commercial teams to deliver validated, compliant, and market-ready solutions. The Director ensures scientific rigor, regulatory compliance, GLP/GMP portfolio prioritization, budget stewardship, and talent development while aligning microbiology initiatives with company growth objectives and customer needs.
Job Responsibilities:
- Leads microbiology strategy for new product development initiatives, including sterility testing, environmental monitoring, bioburden, and experimental applications for the Growth Direct System.
- Oversees day-to-day operations of the R&D microbiology laboratory, including resource planning, workflow optimization, equipment management, and budget control.
- Directs experimental design, validation studies, and feasibility programs within GLP/GMP frameworks.
- Provides technical leadership for growth media formulation, scale-up, and manufacturing validation.
- Serves as a microbiology SME for cross-functional product development teams, supporting design requirements, design verification, risk assessments, and regulatory submissions.
- Manages laboratory personnel, including hiring, performance management, mentoring, and career development.
- Ensures compliance with safety protocols, quality systems, and laboratory best practices.
- Oversees demo laboratory operations and customer application projects, supporting commercial growth and key account strategies.
- Partners with Quality and Manufacturing teams to align best practices and ensure scalable, compliant solutions.
- Reviews and approves complex technical reports, validation protocols, and study results.
- Leads technical investigations, root cause analyses, and risk-based decision-making related to customer support activities.
- Supports global customer engagements, technical presentations, and strategic account initiatives.
- Drives continuous improvement initiatives focused on efficiency, cost optimization, and scientific advancement.
- Manages laboratory inventory, capital planning, and instrument asset utilization.
- Completes special strategic projects, including competitive analysis, statistical studies, and product feasibility assessments.
Education:
- Bachelors degree in microbiology or related life science discipline required.
- Masters degree preferred.
Work Experience:
- 10 years of progressive experience in pharmaceutical, biotech, CRO, CDMO, or regulated laboratory environments, including leadership experience in GLP/GMP settings.
- Technical Experience:
- Sterility testing
- Bioburden and environmental monitoring
- Rapid microbiological methods
- Growth media formulation and validation
- Method validation and regulatory compliance
- Product development lifecycle in regulated environments
- Leadership and Business Competencies:
- Portfolio prioritization and cross-functional program leadership
- Budget management and capital planning
- Talent development and performance management
- Strategic thinking aligned to commercial objectives
- Strong analytical and risk-based decision-making skills
About Rapid Micro Biosystems:
Rapid Micro Biosystems creates, sells, validates, and services innovative products for fast, accurate, and efficient detection of microbial contamination in the manufacture of pharmaceuticals, biologics, biotechnology products, medical devices, and personal care products.
The companys Growth Direct-the first and only growth-based system to automate rapid compendial QC Micro testing-ensures data integrity, compliance, and operational efficiencies driven by rapid methods and automation.
Rapid Micro Biosystems is dedicated to providing groundbreaking technology and products to support companies in their journey to achieve greater reliability, efficiency, and better predictability, ultimately providing higher quality products for improved patient outcomes.
Rapid Micro Biosystems is headquartered in Lexington, Massachusetts. Our research & development and manufacturing operations are located in Lowell, Massachusetts. Additionally, we maintain field offices in Freising, Germany, Switzerland, and Singapore.
Equal Opportunity:
Rapid Micro Biosystems is committed to the principle of equal employment opportunity. Applicants for employment and employees are reviewed on their individual qualifications for a position. Under no circumstances will Rapid Micro Biosystems discriminate against qualified persons on the basis of race, color, religious creed, retaliation, national origin, ancestry, sexual orientation, gender identity, disability, mental illness, genetics, choice of health insurance, marital status, age, veteran status, or any other basis prohibited under applicable law.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
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