Senior Associate Manufacturing - Bulk Drug Substance Downstream - Nights

Amgen•Holly Springs, NC

6d•Onsite

About The Position

Amgen is building a new, advanced drug substance manufacturing plant called the FleX Batch facility. This facility will combine disposable technologies with traditional stainless-steel equipment for maximum operational flexibility. It will feature best-in-class drug substance manufacturing technologies with industry 4.0 capabilities and sustainability innovations to reduce carbon and waste, aligning with Amgen's goal of being a carbon-neutral company by 2027. The Senior Associate will be part of the manufacturing organization at Amgen North Carolina (ANC), supporting critical 24/7 operations. This role involves executing downstream area operations for the manufacturing of cGMP drug substances.

Requirements

High School Diploma/GED + 4 years manufacturing and/or other regulated environment experience
Associate’s Degree + 2 years manufacturing and/or other regulated environment experience
Bachelor’s Degree + 6 months manufacturing and/or other regulated environment experience
Master's Degree + 6 months manufacturing and/or other regulated environment experience
Ability to work assigned 12-hour shift, including during inclement weather, some holidays and requested overtime in support of 24/7 operations.
Understanding of downstream purification operation (Column Chromatography, TFF, Viral Filtration, Viral Inactivation).
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.

Nice To Haves

Completion of NC BioWorks Certification Program
Experience in biotechnology or pharmaceutical plant start up
Knowledge and process experience within a cGMP manufacturing facility or other highly regulated environment

Responsibilities

Completes work in accordance with established cGMP procedures and policies (SOPs, MPs, JHAs, CFR) with strict adherence to safety and compliance.
Initiates quality non-conformance (NC) reports.
Interacts with regulatory agencies as needed and guided.
Assures proper gowning and aseptic techniques are always followed.
Performs hands-on downstream biotech operations (Column Chromatography, Tangential Flow Filtration, Viral Filtration, Viral Inactivation, Column Packing among others) including set-up, operation, cleaning, sanitization, monitoring of equipment and assigned area.
Runs and monitors critical process tasks per assigned procedures.
Performs in-process sampling, operates analytical equipment, and completes process documentation (Electronic Batch Records [EBR]).
Completes washroom activities: cleaning equipment, small to large scale, used in production activities.
Initiates and owns manufacturing-related process deviations.
Identifies, recommends, and implements innovative process improvements and optimizations related to daily routine functions.
Assists in the review of documentation for assigned functions (i.e., equipment logs, EBRs).
Collaborates as part of a cross-functional team (i.e., QA/QC, F&E, PPIC, Mfg., PD, Regulatory, etc.) in completing production activities.
Recognizes and elevates problems during daily operations.
Participates in the implementation of programs and CAPAs with an eye toward continuous improvement.
Drives safety in all operations, and assists the manager in escalating concerns as needed.
Maintains an organized, clean, and workable space.
Drafts and revises 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.