Specialist, Quality Control Bioassay

Amgen SA; Holly Springs (NC); On-site; USD 60,000 - 90,000; Full time

Job summary

A leading biotechnology company seeks a Senior Associate Quality Control to manage the Quality Control Bioassay laboratory. The role involves bioassay testing, document preparation, and training staff. Candidates should possess relevant educational qualifications and preferably experience in GMP settings. Join Amgen to impact patient lives positively while advancing your career.

Qualifications

• Experience in Quality Analytical testing: 4 years with high school diploma / GED; 2 years with Associate's degree; or 6 months with Bachelor's degree.
• Experience in a GMP pharmaceutical production facility preferred.
• Strong knowledge of aseptic technique and equipment validation skills.

Responsibilities

• Assist with planning and execution of equipment installation and qualification.
• Conduct QC bioassay analytical testing for biologic products using ELISA and cell-based methods.
• Train junior staff in bioassay techniques and assays.

Skills

Quality Analytical testing

Data analysis

Communication skills

Aseptic technique

Education

High school diploma / GED

Associate's degree

Bachelor's degree in immunology, Biology, Biochemistry, or related scientific field

Tools

ELISA

Cell-based methods

Job description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

Senior Associate Quality Control

What you will do

Let’s do this. Let’s change the world. In this vital role, you will perform testing and assist with managing the Quality Control Bioassay laboratory. The Specialist, Quality Control Bioassay will report directly to the Senior Manager of Quality Control Bioassay. This role may manage bioassay staff.

• Assist with planning and execution of equipment installation and qualification within the Bioassay lab to support startup.
• Responsible for operating QC bioassay analytical testing for biologic products which includes ELISA and cell-based methods.
• Leading transfer, qualification, and/or validation for the complex biologic procedures.
• Author, revise, and review documents and reports including SOPs, safety assessments, methods, trend reports, qualification/validation summary reports, technical reports, and method assessments.
• Assist with planning, scheduling, and execution of daily activities.
• Work with external partners to ensure successful transfer and release of and stability testing.
• Support all operations of the Bioassay lab including the ordering of supplies, maintaining of equipment and lab spaces.
• Participate in audits, initiatives, and projects that may be interdepartmental or global in scope.
• Own, manage, and participate in deviations, CAPAs, and cross functional investigations.
• Training of junior staff in bioassay techniques and assays.
• Assist with general lab setup and 5S.
• Support routine activities over the weekends and Amgen holidays as needed.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Specialist Quality Control Bioassay we seek is a dynamic, flexible, and driven individual with these qualifications.

Basic Qualifications:

• High school diploma / GED and 4 years of Quality Analytical testing experience OR
• Associate’s degree and 2 years of Quality Analytical testing experience OR
• Bachelor’s degree and 6 months of Quality Analytical testing experience

Preferred Qualifications:

• Experience working in a GMP pharmaceutical production facility with classified areas and applicable gowning requirements.
• Degree in immunology, Biology, Biochemistry, or related scientific field.
• Experience with cell-based methods and ELISA’s, with strong data analysis skills.
• Experience with equipment validation.
• Strong knowledge of aseptic technique.
• Strong written and verbal communication skills, including technical writing and technical presentations.
• Able to flexibly work independently, as a project owner, collaboratively on group tasks, and as a trainer.

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Apply now and make a lasting impact with the Amgen team.

careers.amgen.com

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.