Analyst, Quality Control - Microbiology & Bioassay

Analyst, Quality Control - Microbiology & Bioassay page is loaded Analyst, Quality Control - Microbiology & Bioassay Apply locations Melbourne - Australia Quality time type Full time posted on Posted Yesterday job requisition id R14807 The Role: Reporting to the Associate Director of Quality Control, the Microbiology & Bioassay Quality Control Analyst, will perform Quality Control testing using Bioassay and Microbiology various testing techniques in a GMP testing environment for mRNA products produced at Moderna's manufacturing facility and affiliated contract organizations:

Microbiological method, including Bioburden, Sterility, BET, Micro sequencing, others

Molecular Biology methods, focusing on molecular and protein analytics such as: Agarose Gel Electrophoresis, UV/Vis measurement, Sanger Sequencing, protein concentration determination and qPCR, ELISA, Cell-Based Potency testing, and other methodologies as needed.

routine testing for cGMP QC raw materials, excipients, drug substance and finished product,

This position will contribute to related method transfers and qualification activities; The QC Analyst may also perform projects as assigned.

Here's What You'll Do: Execute GMP QC Molecular Biology methods, focusing on molecular and protein analytics, but also supporting ELISA, Cell-Based Potency testing, and other methodologies as needed.

Execute GMP QC Microbiology methods, focusing on Sterility testing, Bioburden Analysis, Endotoxin, Micro sequencing in addition to other general methods such as TOC and Conductivity testing and other methodologies as needed.

Support testing for drug substances and drug products, including generation of testing data to support other studies as needed.

Conduct analysis related to Bioassay and Microbiology laboratory such as: TOC, Conductivity, Bioburden, Sterility, and Endotoxin, Identification by Sanger Sequencing, qPCR methods execution, ELISA, Cell-Based Potency testing and others.

Perform routine environmental monitoring and critical utility sampling activities, if required

Collaborate with AS&T groups on new methods transfers. Participated in method transfer projects for internal and external testing labs.

Assist in development, implementation, and maintenance of general laboratory operational systems in accordance with cGMP requirements

Provide support to audit teams for internal and vendor audits

Prepare and ship/receive contract laboratory testing samples including those intended for microbiological identification

Perform general laboratory support activities including reagent preparation, equipment maintenance and housekeeping

May participate in equipment and method qualifications, validations, and method transfers

Perform data entry utilizing good documentation practices

May assist with troubleshooting assay methods and equipment. Supports more junior staff with data review, training, and troubleshooting.

Participate in authoring quality systems records such as investigation, deviations, change controls, CAPAs; Write/revise SOPs, protocols, and reports.

Here's What You'll Bring to the Table: BSc/BA in a relevant scientific discipline with 5 years Quality Control experience in a cGMP organization with a focus in Molecular Biology, DNA Sequencing and Microbiology.

Hands on experience with molecular biology techniques including, but not limited to, gel electrophoresis, qPCR, and Sanger Sequencing.

Hands-on experience of various Microbiology testing techniques and analyses (e.g. Vitek, Isolator Technology, Bioburden, BET, Sterility, others)

Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations preferred.

Working experience in a GMP environment.

Ability to collaborate effectively in a dynamic, cross-functional matrix environment.

Ability to efficiently prioritize and complete multiple projects and tasks in a fast-paced environment.

Proven ability to conduct investigations.

Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work. We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:

Quality healthcare and insurance benefits Lifestyle Spending Accounts to create your own pathway to well-being Free premium access to fitness, nutrition, and mindfulness classes Family planning and adoption benefits Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary year-end shutdown Educational resources Savings and investments Location-specific perks and extras! The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.

About Moderna Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. 

By living our mission, values, and mindsets every day, our people  are the driving force behind our scientific progress and our culture.  Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!

Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at ****** . (EEO/AAP Employer) 

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At Moderna we are pioneering the development of a new class of drugs made of messenger RNA (mRNA). This novel drug platform builds on the discovery that modified mRNA can direct the body's cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells.

We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission.

Our Mission: To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients.

Our Vision: To unlock the potential of mRNA by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today.

Third Party Staffing Agencies M oderna does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Moderna from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Moderna and do not obligate Moderna to pay fees if we hire from those resumes.

Reasonable Accommodation Notice Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. Please inform the company's personnel representative by calling 617-460-9346 or emailing ****** if you need assistance completing any forms or to otherwise participate in the application process.Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.

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