Associate Manufacturing - Nights
The Associate Manufacturing is a hands-on role in one of the two manufacturing facilities on site at Amgen Rhode Island. Successful candidates will join either the AR5 team, focused on on-going, high-volume production, or the AR30 team, focused on operational readiness and start-up. Qualifications for this role are the same in both facilities.
The on-boarding phase for this role will last 2-6 weeks, during which time successful incumbents will be on an administrative schedule (Monday through Friday, approximately 8am to 5pm). Following the on-boarding phase, the successful incumbent will be expected to join a shift team working a 12-hour shift. The shift pattern will be 7PM-7AM with a two-week rotation covering 7 days per week. The rotating shift offers several benefits, with an average of 14 days on shift per month with every other weekend off. In addition, any Sundays worked receive Premium pay.
There are multiple openings for this position.
Under general supervision, Associate will perform operations in the Manufacturing area. Operations will be performed according to Standard Operating Procedures (SOPs). Associate will perform and monitor critical processes, execute routine validation protocols, and regularly draft and revise documents such as Manufacturing Procedures, SOPs, and technical reports. Associate will also perform basic troubleshooting and assist in the review of documentation for assigned functions. May participate on cross-functional teams and represent the manufacturing teams. Associate may also have the responsibility of owning deviations/CAPAs. In addition, Associate may identify, recommend, and implement improvements related to routine functions.
Basic Qualifications:
* Bachelor's degree complete by December 2020
* * Associate's degree and 4 years of Manufacturing or Operations experience
* * High School diploma/GED and 6 years of Manufacturing or Operations experience.
Preferred Qualifications:
* Bachelors degree in Science or Engineering
* Knowledge of large-scale biotechnology operations such as purification, cell culture, aseptic processing, etc
* Knowledge of Single-use-Systems
* CFR and Regulatory knowledge
* Mechanical ability/expertise
* Basic statistical mathematical skills
* Ability to interpret and apply GMP knowledge
* Understanding of analytical methods for manufacturing area
* Demonstrated technical writing capability
* Able to demonstrate project management skills and presentation skills
* Ability to understand, apply and evaluate basic chemistry, biology and physical principles
* Basic troubleshooting skills on production equipment
* Experience with Delta V
* Experience with lab equipment/testing
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve peoples lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the worlds leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
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.
Oakland, CA
Amgen Inc. discovers, develops, manufactures, and delivers human therapeutics worldwide. It offers products for the treatment of oncology/hematology, cardiovascular, inflammation, bone health, and neuroscience. The company’s products include Enbrel to treat plaque psoriasis, rheumatoid arthritis, and psoriatic arthritis; Neulasta, a pegylated protein to treat cancer patients; Prolia to treat postmenopausal women with osteoporosis; Aranesp to treat anemia; Xgeva for skeletal-related events prevention; Sensipar/Mimpara products to treat sHPT in chronic kidney disease; and EPOGEN to treat a lower-than-normal number of red blood cells.
It also markets other products in various markets, including Kyprolis, Nplate, Vectibix, Repatha, NEUPOGEN, Parsabiv, Blincyto, Aimovig, Imlygic, Corlanor, Kanjintitm, and Amgevitatm. Amgen Inc. serves healthcare providers, including physicians or their clinics, dialysis centers, hospitals, and pharmacies. It distributes its products through pharmaceutical wholesale distributors, as well as direct-to-consumer channels. The company has collaborative agreements with Novartis; UCB; Bayer HealthCare Pharmaceuticals Inc.; and DaVita Inc. Amgen Inc. was founded in 1980 and is headquartered in Thousand Oaks, California.