The Director, Quality Control (QC) Microbiology will be responsible for providing technical and operational leadership over the microbiology team within the Quality Control (QC) function at Ascend Advanced Therapeutics. This will include, but is not limited to, establishing environmental monitoring and contamination control strategy, developing and/or transferring microbial methods in-house. As part of this role, you will be expected to represent QC microbiology function when interacting with internal and external stakeholders.

Ascend is pioneering the future of healthcare through relentless innovation, our forward-thinking company is on a mission to manufacture safe, efficacious, and scalable gene therapies. Our vision is to set a new standard for gene therapy manufacturing through continuous scientific and process innovation. Our teams, rooted in biopharma, possess regulatory knowledge and prioritize the quality and potency of manufacturing high-class products.

Our goal is to inspire the next generation of experts and breakthrough start-ups in the gene and cell therapy field. With a startup mindset and a track record of rapid growth, we aim to exceed boundaries and achieve continued success. Join us to pursue your passion and make a difference in the industry where there are no limits to what we can achieve. 

• Supervise and mentor direct reports in areas of day-to-day operations and personnel development.
• Provide operational and technical leadership over the microbiology department through management, planning, and allocation of resources. This includes, but is not limited to, microbiological testing (routine EM, bioburden, endotoxin, growth promotion, gram stain, microbial ID analysis, raw materials testing, etc.), data review, personnel training, and equipment maintenance.
• Represent QC at inter-departmental meetings and when interacting with external vendors, as necessary.
• Provide oversight of authoring, reviewing and/or approving documents such as SOPs, Quality Records (deviations, investigations, change controls, CAPA), technical protocol and reports, regulatory submissions, etc.
• Provide oversight over the development and verification of microbial test methods (bioburden, endotoxin, sterility, etc.).
• Ensure laboratory equipment are calibrated/qualified and always in a state of inspection readiness.
• Establish Environmental Monitoring program (qualification, routine testing, and trending) and cross contamination strategy for the manufacturing site in accordance with FDA/EU regulations and applicable International Regulations.
• Manage and track QC microbiology deviations, change controls, CAPAs, and laboratory investigations and ensures that records are closed in a timely manner.
• Act as a subject matter expert during interaction with regulatory agencies, filing/submissions, supporting and responding to internal and external audit responses, developing contamination control strategy, etc.
• Inculcate culture of continuous improvement within the team and implement process improvement initiatives.
• It should be noted that this job description is subject to change at any time.
• Other job duties as assigned.

Additional Qualifications

• Demonstrated understanding of cGMPs, FDA and EMA regulatory guidelines.
• Hands on experience with verification/qualification and execution of microbial methods in a cGMP environment.
• Self-starter with strong work ethic and ability to work independently with minimum supervision and using good judgment.
• Strong organizational, analytical, and problem-solving skills.
• Ability to analyze data and perform structured decision-making.
• Experience working with contract testing laboratories.
• Experience with participating in regulatory audits and inspections, highly preferred
• Proficient with Microsoft Office Suite, Project Management programs (e.g., Smartsheet), etc.
• Proficient in oral and written communication.

• Annual bonus

• 401k matching up to 3%, 50% on the next 2%
• Medical, Dental, Vision, Life, Short-Term and Long-Term Disability, AD&D, and additional insurances.
• 20 days PTO
• 5 days Sick leave
• 6 weeks Parental Leave