Danaher Jobs

QC Microbiology Scientist

Aldevron Quality Statement

All employees of Aldevron are expected to be conscientious, self-motivated professionals, courteous to fellow staff members and clients, and to consistently perform their duties in a manner of the highest quality. Each individual working for the company has the responsibility for assuring the integrity and quality of the products and services the company provides.

POSITION DESCRIPTION

Department: Quality Control (Clinical Grade)

Reports to: Microbiology Manager

Classification: Exempt

Position Summary

The QC Microbiology Scientist will be responsible in performing Microbial risk assessments for environmental monitoring, in process and final product isolates found at the Aldevron Fargo facility. Responsibilities will also include providing guidance on subculture medias and techniques, partaking in the environmental action committee, performing method optimization and method development/method validation as needed for microbiology related methods, assistance in Microbial investigations, and providing guidance on contamination control strategies.

Essential Functions

• Perform Microbial risk assessments (objectionable/not objectionable) for all above action level excursion at the Aldevron site.

• Research organisms of concern

• Provide scientific justification based off literature on why organism is objectionable or non-objectionable.

• Provide guidance on growth medias for difficult to subculture organisms

• Assist in contamination control initiatives throughout the site

• Participate in Environmental Action Committee

• Review statistical data for trends

• Draft trend reports

• Identify root causes based off data and investigations.

• Including advising on remediation of organisms detected.

• Develop, write, and assist with new microbiology methods/protocols by providing guidance, supervising the work of analysts or through collaboration with other groups, including contract testing laboratories.

• Ensure that methods are robust and fit-for-purpose.

• Lead activities associated with method validations and transfers including development of validation strategies to meet regulatory requirements.

• This includes authoring qualification, validation, and verification protocols; analyzing results against pre-determined acceptance criteria; and authoring final reports

• Provide training to analysts for newly developed methods that are ready for validation

• Contribute to Quality Event reports for Out of Specification (OOS) investigations or other laboratory investigations including Root Cause determination and Corrective Actions and Preventative Actions (CAPA), as needed

• Identify new techniques and instrumentation to expand internal capabilities. Prepare justification for new lab equipment.

• Create, revise, and finalize standard operating procedures (SOP), product specifications, and other GMP documents

• Perform other duties as assigned

• All employees are responsible for the general upkeep of work and shared spaces

• Punctual and regular attendance is required of all employees

Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions of the position.

Supervisory Responsibility

N/A

Travel

N/A

Qualifications

Experience:

• Minimum 4 years of experience working in a microbiology laboratory environment in a contamination control role or equivalent.

• Experience in performing microbial risk assessments

• Understanding of MicroSEQ, Maldi-TOF, Gram staining, other microbial identification platforms.

• Experience in assay development, optimization, experimental design, and data analysis, preferably in a GMP environment

Education

• BS. in microbiology or related scientific field with 4+ years of relevant experience. preferred. Master’s degree with relevant work experience.

Skills & Knowledge

• Strong background in microbial risk assessment

• Strong background in MicroSEQ and organism identification

• Previous experience with contamination control

• Experience in microbiology method validations and transfers is highly preferred.

• Previous GMP experience is highly preferred.

• Knowledge of regulatory documents including ICH, USP, EP, and FDA guidance documents

• Familiarity with data collection and management software such as electronic laboratory notebooks (ELN) and LIMS is a plus

Abilities

• Ability to work on cross functional teams.

• Must be able to develop solutions for simple and complex problems, which require a high degree of ingenuity, creativity, and innovation

• Demonstrate high ethical standards, trustworthiness with strong communication and leadership skills

Working Conditions

This position works in a Clinical or Research Grade lab setting and may come in contact with various solutions and chemicals and will be responsible for activities related to biological processes such as bacterial growth. This position may use standard laboratory equipment such as pipettes, centrifuges, glassware, shake flasks, fermenters, fume hoods, and computers.

Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position.

EEO

When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.The EEO posters are available here (https://www.dol.gov/agencies/ofccp/posters) .We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation. If you’ve ever wondered what’s within you, there’s no better time to find out.