Quality Control Microbiologist

Ascend is currently recruiting for a Microbiologist to perform GMP QC testing in the laboratories at the Ascend facility Alachua, FL. The QC Microbiologist will be participating in the day-to-day operation of CGMP compliant QC Microbiology laboratory of Ascend to include performing and providing support for functional aspects of the facility such as environmental and utility monitoring, microbiological testing of samples, media fills, water testing, and other activities that support execution of testing of CGMP samples for in-process, lot release and stability samples in-house.

About Ascend:

Ascend is a new model for gene & cell therapy design, development, and manufacturing. We partner with ambitious biotechnology teams to embed scalable manufacturing in their operations from the beginning. We support manufacturing and process development projects from design through to clinical and commercial scale.

Why we’re different:

Are you interested in growing in an interdisciplinary creative space and pursuing your passion projects? We’re building a place for people inspired by the possibilities of biological engineering for gene & cell therapy technologies. We want to lift a new generation of experts and breakthrough start-ups. That's why the Ascend model includes the opportunity of cross-functional training to enhance professional development and continually seed fresh ideas.

The Role:

• Following QMS Policies and Procedures required to perform testing.
• Performing testing in compliance with company and regulatory requirements (GMP, Safety and Environmental).
• Ability to perform work while fully gowned within the clean room environment of the gene therapy production facility. To include environmental and utility monitoring including operational and personnel monitoring during aseptic processing and aseptic filling.
• Perform microbiological assays, including bioburden, endotoxin, mycoplasma, sterility, pharmaceutical water testing, etc.
• Supporting onboarding and qualification of laboratory equipment and GMP software systems.
• Purchase all necessary supplies needed for QC Microbiology. Receive supplies, log-in and store appropriately according to written procedures. Perform growth promotion analyses on all microbiological media lots received. Report results on appropriate forms and review results of peers.
• Inspect and clean the laboratory and its equipment on a regular basis.
• Record all necessary information and maintain current, accurate, legible records of all work performed. Report problems to management.
• Writing and reviewing QC documents, method validation documents, test methods and results, and summary reports, quarterly and annual reports, for compliance with testing specifications and procedures.
• Assisting the QC Microbiology Director with Change Controls, Deviations, Investigations and CAPAs and evaluating their potential impact on analytical results and product quality.
• Supporting tech transfer of microbiological methods into QC.
• Maintaining an up-to-date knowledge of the new and emerging regulations related to QC Facilities and operations.
• Ensuring a safe work environment.
• Performance, development and qualification of microbiological development assays when directed by the QC Microbiology Director.
• Ensure compliance to all quality requirements to meet audit standards and regulatory compliance.
• Assist in training staff on methods and related SOPs.
• Perform sample management tasks, including labelling, shipping to external labs, inventory and disposal of samples.
• Provide support for other duties, as assigned by management.

• Bachelor’s Degree in Microbiology, Molecular and Cell Biology, Biology or similar related field required

• More than four years of work experience in the Pharmaceutical, Life Sciences industry with CGMP.
• Experience with relevant microbiology laboratory equipment and software.
• Basic knowledge of Compendial (ie, USP, EP, etc) requirements and standards.
• Understanding of the principles of GMP.
• Ability to make decisions and manage priorities in alignment with department objectives.
• Ability to present data in a clear and understandable way.
• Ability to think logically and evaluate complex situations to arrive at the true root cause.
• Experience in Microsoft Office applications.
• Strong Team player, with focus on safety, quality and timelines.
• Ability to work in a fast-paced environment and to prioritise own work.
• Good Written & Oral Communication skills, German and English.

• 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

Company Values:

Aim Higher – Our motto and values. 

• Quality by integrity - We set high standards, putting quality and evidence first to seek the best solutions.
• Adaptability is in our DNA - We are forward-thinking problem solvers, driven by the developing science and to deliver the best medicines.
• Serving patients by serving our partners - We can depend on each other, and on the organisation, to deliver goals and services.

To start your journey with us at Ascend, kindly submit your resume and a cover letter showcasing your qualifications and interest in the role. We value diversity and oppose discrimination. While we eagerly await all applications, we'll only reach out to selected candidates for interviews. Please note that successful candidates must be legally authorized to work in the United States and will undergo E-verify authentication. Thank you for considering joining our team as we shape the future together!