Director of Microbiology & IVD Product Development

Job Title: Director of Microbiology & Product Development

At Pattern Bioscience, we're tackling antibiotic resistance, one of the biggest public health challenges of our time. We are building a single-cell microbiology platform to quickly recognize the bacteria causing an infection and to predict which antimicrobials will be active against the infection.

We are seeking a Director of Microbiology & Product Development to oversee assay development, reagent development, design transfer, quality control, GLP studies (including leading analytical validation studies for regulatory submissions), and microbiology related product challenges. In this role, you will lead formally and informally, interacting with groups in R&D, Quality, Regulatory, Clinical Affairs, and Manufacturing. In addition to overseeing the daily operational activities of the Microbiology Laboratory, you will play a significant role in product development including leading GLP studies for FDA submissions, and you will contribute to resolving design transfer and quality control challenges. You will also participate in research collaborations internally and with external partners. The successful candidate must have excellent leadership and communication skills, with the ability to manage competing priorities and adapt to changing business conditions.

This role is for you if are passionate about addressing antimicrobial resistance, generating & analyzing data, building and implementing laboratory systems & processes, teaching & mentoring teammates, validating novel IVD assays, and are driven to take on new challenges. Below we've included a few ways you can have an immediate impact on our mission.

Responsibilities

• Provide leadership and guidance to the microbiology team, ensuring that all activities are executed in compliance with relevant regulations and standards (GLP, FDA, etc.).

• Anticipate, mitigate, and troubleshoot reagent, microbiology, and future product challenges.

• Develop and validate assays in regulated environments, with domain expertise in IVD.

• Analyze data and summarize results to inform decision-making.

• Create study reports and generate content to support regulatory submissions.

• Manage competing priorities and ensure that projects are delivered on time and to a high standard.

• Communicate effectively with internal stakeholders and external partners to ensure that all microbiology-related activities are coordinated effectively.

• Foster a culture of collaboration, respect, and accountability within the microbiology team and across the wider organization.
• Maintain up-to-date knowledge of microbiology trends, technologies, and regulatory requirements.

Goals

90 day

• Lead microbiology team in establishing the specimen and microbial isolate bank needed to support clinical trials and path to commercialization

• Finalize protocols for analytical studies

• Inventory levels and operational readiness of sample bank to support analytical studies

• Collaborate with assay research team on design transfer activities

• Finalize design output trace matrix

• Recruit and develop product development team
• Support regulatory team in interactions with FDA

6 month

• Initiate analytical performance studies

• Support clinical affairs team during preparation for and execution of a multi-center clinical study

• Execute design review to carry product into formal studies

• Build a team with strong competencies in microbiological practices and execution of controlled performance studies

• Lead external studies to support publications with KOLs

How You Will Contribute

• Lead the microbiology organization to ensure accuracy, compliance, and consistency; streamline workflows and optimize study designs.

• Lead analytical studies and assay verification, contribute to design control documents, and support protocol development.

• Act as the key liaison between R&D, Clinical, Quality, Regulatory and Manufacturing departments providing support, training, and ensuring seamless communication.

• Oversee the use, expansion, and maintenance of the microbial strain bank.

• Lead the transition of Pattern laboratories to meet GLP and GCP standards.

• Communicate effectively with internal stakeholders and external partners to ensure that all microbiology-related activities are coordinated effectively.

• Foster a culture of collaboration, respect, and accountability within the microbiology team and across the wider organization.

• Support Regulatory team in interactions with FDA.

• Manage external studies in collaboration with key opinion leaders (KOLs) and support scientific publications.

• Support manuscript preparation: synthesize data, create figures, and contribute to literature reviews and writing.

• Contribute subject matter expertise to clinical protocol development, including study design, quality control methods, and data analysis plans.

• Support the team and/or be part of the team representing Pattern at local, regional, and national conferences.

Desired Education and Experience

• At least 5 years in a leadership role (including people leadership)

• Scientist with in-depth knowledge of assay transfer and product development

• Experience working in a regulated environment (e.g. IVD, CAP, CLIA, USDA, etc.)
• Master of Science or PhD in microbiology, molecular biology, or related discipline

Skills or Attributes Considered a plus:

• Successful track record of developing and clearing novel IVD assays

Details

Join us! We're excited for what you can bring to our team. Here are a few things we provide to make sure you have a great experience. Learn more about our team by visiting our website.

Benefits

• Health insurance

• 401k Matching

• Paid Time Off

• The opportunity to make a global impact

To fulfill our mission and build world-changing technology, we've put together a diverse, multi-disciplinary top-notch team, a culture of innovation, learning, adaptability, and excellence and environment where people love coming to work.

We value diversity on our teams. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity or expression, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.