Associate Mfg

This role will support manufacturing operations, as such some extended hours, shift, and weekend work flexibility may be necessary as required. Under minimal supervision, responsible for one or more of the following activities in Manufacturing:

• Analytical testing, characterization, sample and data management
• Equipment maintenance
• Contributes to team by ensuring the quality of the tasks/services provided by self
• Contributes to the completion of milestones associated with specific projects or activities within the team.
• Support manual visual inspection of filled units

Specific Job Duties:

• Plan and perform routine analyses with efficiency and accuracy.
• Plan and perform multiple, complex routine/non-routine methods and procedures and a large variety of assays.
• May perform aseptic aliquoting, sampling and analysis of compendia methods
• Perform accurate laboratory/manufacturing documentation following GMP guidelines.
• With a high degree of technical flexibility, work across diverse areas within the lab.
• Evaluate analytical data
• Perform general lab/area housekeeping
• Maintain/operate specialized equipment
• Comply with safety guidelines, GMPs and other applicable regulatory requirements
• Initiate and/or implement changes in controlled documents
• Troubleshoot, solve problems and communicate with stakeholders
• Participate in audits, initiatives, and projects that may be departmental or organizational in scope
• Evaluate lab practices for compliance and operational excellence improvements on a continuous basis
• May participate in lab/inspection deviation investigations
• May own deviation/CAPA records
• May provide technical guidance
• May train other staff
• May contribute to regulatory filings
• May represent the department/organization on various teams
• May interact with outside resources
• Support manual visual inspection of drug product filled units
• Deepens technical knowledge trough exposure and continuous learning

Basic Qualifications:

Bachelor's degree

OR

Associates Degree and 4 years of biotech or pharmaceutical manufacturing, process development or quality experience

OR

High School Diploma / GED and 6 years of biotech or pharmaceutical manufacturing, process development or quality experience

Preferred Qualifications:

• Bachelor's degree in Life Sciences & minimum 2 years of biotech industry QC experience/GMP laboratory/manufacturing (preferably in manual visual inspection) experience.
• Experience with regulatory compliance in GMP manufacturing and testing of pharmaceutical products.
• Take initiative to identify and drive improvements
• Excellent verbal and written communication skills
• Strong technical writing skills for GMP documentation (e.g. investigations, procedures, change controls)
• Presentation skills
• Escalate issues professionally and on a timely basis
• Decision making skills
• Teamwork and coaching others
• Negotiation and influencing skills
• Project management and organizational skills
• Ability to interact with regulatory agencies
• Data trending and evaluation
• May set project timeframes and priorities based on project objectives and ongoing assignments. Recognizes and escalates problems.
• Ability to work independently and deliver right the first-time results
• Follows procedures. Refers to technical standards, principles, theories and precedents as needed.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

We understand that to successfully sustain and grow as a global enterprise and deliver for patients - we must ensure a diverse and inclusive work environment.

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, or disability status.
Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
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, or disability status.

.