Senior Associate Manufacturing - Bulk Drug Substance Downstream - Days
headings for each section, and - for lists,
for prose.
We need to avoid repeating job title as heading. No Job ID.
We must not include sections with filler like "commensurate with experience". We have actual content.
We need to preserve all substantive info; not invent or summarize away detail. So we need to keep the details as they appear, but we can format into lists.
We must not include boilerplate like EEO, application instructions.
Let's craft.
First, About the role: combine introductory paragraph(s) up to "Live What You Will Do". Actually the phrase "Live What You Will Do" seems weird; maybe it's a heading but we ignore. We'll produce a paragraph summarizing the role: mission, facility, role description.
We'll put in
.
Responsibilities: we need to list duties. Could break into bullet points.
Let's extract duties:
- Senior Associate in manufacturing organization at Amgen North Carolina (ANC) supporting facility expansion program and facility startup.
- Part of team responsible for manufacturing downstream purification operations including column packing, column chromatography, TFF, viral filtration, viral inactivation, conjugation, and final fill.
- Partner across functions to ensure successful operational readiness, technology transfer, and ramp-up of manufacturing operations within new facility.
- May require work outside standard business hours, including nonstandard shifts, as needed to support startup, commissioning and qualification (C&Q), and engineering execution.
- During early phases, expected to work Monday-Friday schedule from 8am-5pm.
- As business moves from C&Q to manufacturing operations, will work a 12-hour 2-2-3 schedule from 5:45am to 6:15pm supporting critical 24/7 manufacturing operations.
- Must be able to work assigned 12-hour shift, including during inclement weather, some holidays and requested overtime.
- During early phases, focus on operational readiness, training, and startup execution.
- As facility transitions to steady-state operations, shift toward routine manufacturing execution and continuous improvement.
- Completes work in accordance with established cGMP procedures and policies (SOPs, MPs, JHAs, 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.
- Assure proper gowning and aseptic techniques are always followed.
- Support operational readiness activities for facility expansion and startup.
- Execute manufacturing readiness tasks including equipment preparation, procedure execution, and process walkthroughs.
- Participate in commissioning, qualification, and startup activities as trained and assigned.
- Provide operational feedback during startup activities to support safe, compliant, and efficient manufacturing.
- Support readiness planning through execution of training, procedures, workflows, and operational practices required for startup and ramp-up.
- Perform hands-on operations including set-up, cleaning, sanitization, monitoring of equipment of assigned area.
- Run and monitor critical process tasks per assigned procedures.
- Perform in-process sampling, operate analytical 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 innovative process improvements and optimizations related to daily routine functions.
- Assist in the review of documentation for assigned functions (i.e., equipment logs, EBRs, ESPs).
- Collaborate cross-functionally (QA/QC, F&E, PPIC, Mfg., PD, Regulatory, etc.) in completing production activities.
- Responsible for recognizing and elevating problems during daily operations.
- Participate in implementation of programs and CAPAs (Corrective Action Preventive Action) with an eye toward continuous improvement.
- Drive safety in all operations, and assist the manager in escalating concerns as needed.
- Maintain an organized, clean, and workable space.
- 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.
That's a lot. We'll put as
- .
Requirements: Basic Qualifications: list options.
- High School Diploma/GED + 4 years manufacturing and/or other regulated environment experience
- OR Associates Degree + 2 years manufacturing and/or other regulated environment experience
- OR Bachelors Degree + 6 months manufacturing and/or other regulated environment experience
- OR Master's Degree
We'll put as
.
Qualifications: Preferred Qualifications list:
- Completion of NC
for prose. We need to avoid repeating job title as heading. No Job ID. We must not include sections with filler like "commensurate with experience". We have actual content. We need to preserve all substantive info; not invent or summarize away detail. So we need to keep the details as they appear, but we can format into lists. We must not include boilerplate like EEO, application instructions. Let's craft. First, About the role: combine introductory paragraph(s) up to "Live What You Will Do". Actually the phrase "Live What You Will Do" seems weird; maybe it's a heading but we ignore. We'll produce a paragraph summarizing the role: mission, facility, role description. We'll put in
. Responsibilities: we need to list duties. Could break into bullet points. Let's extract duties: - Senior Associate in manufacturing organization at Amgen North Carolina (ANC) supporting facility expansion program and facility startup. - Part of team responsible for manufacturing downstream purification operations including column packing, column chromatography, TFF, viral filtration, viral inactivation, conjugation, and final fill. - Partner across functions to ensure successful operational readiness, technology transfer, and ramp-up of manufacturing operations within new facility. - May require work outside standard business hours, including nonstandard shifts, as needed to support startup, commissioning and qualification (C&Q), and engineering execution. - During early phases, expected to work Monday-Friday schedule from 8am-5pm. - As business moves from C&Q to manufacturing operations, will work a 12-hour 2-2-3 schedule from 5:45am to 6:15pm supporting critical 24/7 manufacturing operations. - Must be able to work assigned 12-hour shift, including during inclement weather, some holidays and requested overtime. - During early phases, focus on operational readiness, training, and startup execution. - As facility transitions to steady-state operations, shift toward routine manufacturing execution and continuous improvement. - Completes work in accordance with established cGMP procedures and policies (SOPs, MPs, JHAs, 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. - Assure proper gowning and aseptic techniques are always followed. - Support operational readiness activities for facility expansion and startup. - Execute manufacturing readiness tasks including equipment preparation, procedure execution, and process walkthroughs. - Participate in commissioning, qualification, and startup activities as trained and assigned. - Provide operational feedback during startup activities to support safe, compliant, and efficient manufacturing. - Support readiness planning through execution of training, procedures, workflows, and operational practices required for startup and ramp-up. - Perform hands-on operations including set-up, cleaning, sanitization, monitoring of equipment of assigned area. - Run and monitor critical process tasks per assigned procedures. - Perform in-process sampling, operate analytical 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 innovative process improvements and optimizations related to daily routine functions. - Assist in the review of documentation for assigned functions (i.e., equipment logs, EBRs, ESPs). - Collaborate cross-functionally (QA/QC, F&E, PPIC, Mfg., PD, Regulatory, etc.) in completing production activities. - Responsible for recognizing and elevating problems during daily operations. - Participate in implementation of programs and CAPAs (Corrective Action Preventive Action) with an eye toward continuous improvement. - Drive safety in all operations, and assist the manager in escalating concerns as needed. - Maintain an organized, clean, and workable space. - 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. That's a lot. We'll put as
- .
Requirements: Basic Qualifications: list options.
- High School Diploma/GED + 4 years manufacturing and/or other regulated environment experience
- OR Associates Degree + 2 years manufacturing and/or other regulated environment experience
- OR Bachelors Degree + 6 months manufacturing and/or other regulated environment experience
- OR Master's Degree
We'll put as
- .
Qualifications: Preferred Qualifications list:
- Completion of NC