Hybrid Senior Associate Quality Control Support - Stability-Holly Springs, NC en Amgen
Amgen · Holly Springs, Estados Unidos De América · Hybrid
- Professional
- Oficina en Holly Springs
Job Description
ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.
At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
Since 1980, we’ve helped 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’ll help 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 that lay within them, you’ll thrive 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 Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch 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 Quality Control Support -Stability
What you will do
Let’s do this. Let’s change the world. In this vital role, you will be responsible for supporting the site Stability team QC start up and operations. Responsibilities will include writing procedures and reports and executing activities to support stability related initial lab equipment installation, qualification, and validation, and establishment of the stability laboratories. Role may involve travel to support method or knowledge transfers. The Senior Associate QC Stability will report directly to the Director of Quality Control. This individual will act as the site subject matter expert for the Stability program. This role will support manufacturing operations, and as such some extended hours, shift and weekend work may be necessary.
Under minimal supervision, the successful candidate will support the startup of the QC organization by:
Drive implementation of Stability Program at ANC by establishing site specific processes and procedures, ensuring alignment with Amgen's Global Stability Program Strategy
Manage clinical/commercial stability products, encompassing drug substance intermediates and drug substance for clinical/commercial programs
Manage Stability Requests with Global Stability Coordinators and Product Quality Leads
Ensure proper storage conditions for the ANC QC Stability Program maintaining sample integrity, including availability of back-up CTCs and appropriate segregation for all stability studies
Ensure Stability Samples are processed in a timely manner and placed on stability according to the approved Stability Protocol
Ensure stability studies are initiated within protocol timelines
Work collaboratively with site teams
Ensure stability program is adherent to all cGMP regulations
Participate in audits, initiatives, and projects that may be interdepartmental or global in scope.
Support routine activities over the weekends and public holidays as required.
At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
Since 1980, we’ve helped 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’ll help 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 that lay within them, you’ll thrive 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 Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch 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 Quality Control Support -Stability
What you will do
Let’s do this. Let’s change the world. In this vital role, you will be responsible for supporting the site Stability team QC start up and operations. Responsibilities will include writing procedures and reports and executing activities to support stability related initial lab equipment installation, qualification, and validation, and establishment of the stability laboratories. Role may involve travel to support method or knowledge transfers. The Senior Associate QC Stability will report directly to the Director of Quality Control. This individual will act as the site subject matter expert for the Stability program. This role will support manufacturing operations, and as such some extended hours, shift and weekend work may be necessary.
Under minimal supervision, the successful candidate will support the startup of the QC organization by:
Drive implementation of Stability Program at ANC by establishing site specific processes and procedures, ensuring alignment with Amgen's Global Stability Program Strategy
Manage clinical/commercial stability products, encompassing drug substance intermediates and drug substance for clinical/commercial programs
Manage Stability Requests with Global Stability Coordinators and Product Quality Leads
Ensure proper storage conditions for the ANC QC Stability Program maintaining sample integrity, including availability of back-up CTCs and appropriate segregation for all stability studies
Ensure Stability Samples are processed in a timely manner and placed on stability according to the approved Stability Protocol
Ensure stability studies are initiated within protocol timelines
Work collaboratively with site teams
Ensure stability program is adherent to all cGMP regulations
Participate in audits, initiatives, and projects that may be interdepartmental or global in scope.
Support routine activities over the weekends and public holidays as required.
Job_Category
Pharmaceutical
Minimum Education Required
High School/GED
City*
Holly Springs
Additional Qualifications/Responsibilities
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The vital professional we seek is an effective leader with these qualifications.
Basic Qualifications:
High School/GED + 4 years of Quality work experience OR
Associate’s + 2 years of Quality work experience OR
Bachelor’s + 6 months of Quality work experience OR
Master's
Preferred Qualifications:
Degree in a related scientific field such as Chemistry, Microbiology, Molecular Biology, Physics or Engineering.
3-5 years of relevant laboratory experience in the GMP commercial manufacturing environment within the pharmaceutical or biopharmaceutical industry and analytical testing experience preferred.
Solid understanding of aseptic technique.
Proficient in the use of Veeva and Trackwise systems
Experience in a lead role, providing guidance to team members.
Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discover.
Strong knowledge of aseptic technique.
Proficient in the use of LIMS & LMES/CIMS.
Strong written and verbal communication skills including technical writing and presentation.
Familiar with authoring or owning change control records.
Experience with equipment and method validation, verification, and transfer including the change control process.
Interact effectively with variety of communication and working styles and ability to work well in teams.
Salary Range
81,082.00 USD - 98,151.00 USD
We are all different, yet we all use our unique contributions to serve patients. The vital professional we seek is an effective leader with these qualifications.
Basic Qualifications:
High School/GED + 4 years of Quality work experience OR
Associate’s + 2 years of Quality work experience OR
Bachelor’s + 6 months of Quality work experience OR
Master's
Preferred Qualifications:
Degree in a related scientific field such as Chemistry, Microbiology, Molecular Biology, Physics or Engineering.
3-5 years of relevant laboratory experience in the GMP commercial manufacturing environment within the pharmaceutical or biopharmaceutical industry and analytical testing experience preferred.
Solid understanding of aseptic technique.
Proficient in the use of Veeva and Trackwise systems
Experience in a lead role, providing guidance to team members.
Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discover.
Strong knowledge of aseptic technique.
Proficient in the use of LIMS & LMES/CIMS.
Strong written and verbal communication skills including technical writing and presentation.
Familiar with authoring or owning change control records.
Experience with equipment and method validation, verification, and transfer including the change control process.
Interact effectively with variety of communication and working styles and ability to work well in teams.
Salary Range
81,082.00 USD - 98,151.00 USD
State*
North Carolina
Salary Range
$75,000-$100,000
