Scientist Biopharma Manufacturing Quality Control Analyst II Microbiology SFD-TC, Quality Control – NC

About Astellas

Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com.

Are you driven to make a real difference in the lives of patients?

We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.

Purpose & Scope

This resource will be part of the Quality Control Microbiology team located at the Sanford TC in Sanford, NC, and will be responsible for environmental and utility sampling and testing, as well as additional lab functions as needed. This role will support QC testing for any products manufactured at the Sanford TC.

The Analyst II, Quality Control Microbiology will be responsible for implementing and executing microbiological testing in support of clinical and commercial products in compliance with GMP requirements. This role will also support testing for stability studies, method validation studies and equipment validation.

Role and Responsibilities

• Schedule Environmental and Utility Monitoring, ensuring all samples are collected as required

• Perform Environmental and Utility Monitoring

• Author/revise technical reports and laboratory procedures

• Author/review electronic database improvements

• Assist in data trending and summarization

• Participate in deviation and OOS investigations

• Perform plate reading and generate microbial isolates

• Receive, unpack and organize supplies for QC areas

• Perform routine cleaning, schedule equipment preventative maintenance, and organization of laboratory areas in accordance with cGMP

Other duties as required:

• Perform release, stability, and in-process testing supporting production activities. Testing includes, but is not limited to bioburden, endotoxin, pH/conductivity

• Perform growth promotion/media qualification

• Perform testing in support of method transfer/validations

• Participate in equipment qualification/validation studies

• Perform QC lab support activities including but not limited to sample management, reagent preparation, instrumentation maintenance, and instrument calibration

Required Qualifications

• B.S. Degree in Microbiology, or other science-related degree, with 0-2+ years’ relevant industry experience in a quality control role.

• Demonstrated experience of aseptic technique and common microbiological and environmental monitoring testing.

• Knowledge of relevant compliance and guidance documents.

• Must be able to gown into cleanrooms in support of testing and manufacturing activities.

• Good documentation and data organization.

• Detail oriented and willingness to learn.

• Strong interpersonal skills which contribute to a supportive and positive work environment

• Proven history of working in a fast-paced team environment, time management, and meeting deadlines.

• Highly collaborative team player with the ability and willingness to support other colleagues in the Quality Control department.

• Flexibility to cover off-shift work (e.g., weekends) will be required.

Preferred Qualifications

• Experience in a small company and high growth, fast-paced environment

• Experience in qualification of analytical equipment, including those with computerized systems

• Experience in method validation/qualification/verification/transfer

Location and Working Environment

• This position is based in Sanford, NC and will require on-site work in a cGMP regulated manufacturing facility.

• This role frequently requires long periods of sitting, standing and use of hands and regular motion to include bending, stooping, and lifting up to 20lbs.

What awaits you at Astellas?

• Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide.

• Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.

• Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.

• A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.

Our Organizational Values and Behaviors

Values: Innovation, Integrity and Impact sit at the heart of what we do.

Behaviors: We come together as ‘One Astellas’ , working with courage and a sense of urgency . We are outcome focused and consistently take accountability for our personal contribution.

Salary Range

$69,790-$99,700 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations.)

Benefits:

• Medical, Dental and Vision Insurance

• Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down

• 401(k) match and annual company contribution

• Company paid life insurance

• Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions

• Long Term Incentive Plan for eligible positions

• Company fleet vehicle for eligible positions

• Referral bonus program

#LI-TR1

Category Sanford TC

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans