Senior Associate Manufacturing, Upstream - Nights
Senior Associate Manufacturing, Upstream - Nights
US - North Carolina - Holly Springs APLICAR AHORAJoin Amgen’s Mission of Serving Patients
At Amgen, if you feel likeyou’repart of something bigger,it’sbecause you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
Since 1980,we’vehelped 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’llhelp 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 thatlaywithin them,you’llthrive 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 AmgenFleXBatch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. TheFleXBatch 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 Manufacturing,Upstream (Nights)
What youwill do
Let’s do this! Let’s change the world! In this dynamic role, you will be aSrAssociate in the manufacturing organization atAmgenNorth Carolina (ANC). The essential position, which supports our critical 24/7 manufacturing operations, works a 12-hour 2-2-3 schedule from 5:45pm to 6:15am. Associates will beexecutingoperations on the floor in ourupstream area and will be responsible for the manufacturing of cGMP (Current Good Manufacturing Practices) drug substances.
With general direction, the Senior Associateis responsible forexecuting on-the-floor operations within manufacturingin accordance withcGMP practices.As Amgen relies upon the regular attendance of staff members to meet legitimate business needs, staff must be able to work assigned 12-hour shift, including during inclement weather, some holidays and requested overtime in support of our 24/7 operations.
Compliance:
Completes workin accordance withestablished cGMP procedures and policies (Standard Operating Procedures [SOPs], Manufacturing Procedures [MPs], Job Hazard Analysis [JHAs], Code of Federal Regulations [CFR]) with strict adherence to safety and compliance
Initiate Quality observations (Discrepancies, Deviations, Testing Results Analysis (TRA),etc.) as well as support or lead evaluations and investigations into quality observations
Interact with regulatory agencies as needed and guided
Assureproper gowning and aseptic techniques are always followed
Process/Equipment/Facilities:
Perform hands-on operations including set-up, cleaning, sanitization, monitoringof equipmentofassigned area
Run andmonitorcritical process tasksperassigned procedures
Perform in-process sampling,operateanalytical equipment, and complete process documentation (Electronic Batch Records [EBR])
Complete washroom activities: cleaning equipment, small to large scale, used in production activities
Identify, recommend, and implement innovativeprocess improvements and optimizations related to daily routine functions
Assistin the review of documentation for assigned functions (i.e., equipment logs, EBRs, ESPs)
Collaborate cross-functionally(i.e., QA/QC, F&E (Facilities & Engineering), PPIC(Production Planning and Inventory Control), Mfg., PD (Process Development), Regulatory, etc.) in completing production activities
Responsible for recognizing and elevating problems during daily operations
Participate in the implementation of programs and CAPAs (Corrective Action Preventive Action) with an eye toward continuous improvement
Drive safety in all operations, andassistthe manager in escalating concerns as needed
Maintain an organized, clean, and workable space
Administrative:
Draft and revise documents (SOPs, technical reports, and MPs)
Interacts with management as an advisor in planning and in escalating potential concerns with the schedule and/or process
What we expectofyou
We are all different, yet we all use our unique contributions to serve patients. The hard-working professional weseekis a team player with these qualifications.
Basic Qualifications:
High School Diploma/GED + 4 years manufacturing and/or other regulated environment experience OR
Associate’s Degree+ 2 years manufacturing and/or other regulated environment experience OR
Bachelor’s Degree + 6 months manufacturing and/or other regulatedenvironmentexperience OR
Master's Degree
Preferred Qualifications:
Completion of NCBioWorkCertificate Program
Experience in biotechnology or pharmaceutical plant start up
Knowledge and process experience within a cGMP manufacturing facility or other highly regulated environment
Basic understanding of Upstream operation (Vial Thaw, Inoculation/Cell Expansion, Single Use Bioreactor, Production Bioreactor, ATF, Harvest Centrifuge, Depth Filtration)
Excellent verbal and written communication (technical) skills
Proficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems
What you can expectofus
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’llsupport 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.