What are the responsibilities and job description for the Manufacturing Specialist - Thousand Oaks, CA position at VetJobs?
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.
Specialist Manufacturing
What you will do
Let’s do this. Let’s change the world. In this vital role you will investigate deviations in the Amgen Thousand Oaks Manufacturing Clinical Supply Organization, including Drug Substance and Drug Product manufacturing, Supply Chain, Drug Product Assembly/Packaging, Quality Control, and Warehouse Operations. These investigations are aligned with regulatory requirements and include determination of scope, product impact, root cause, and effective corrective/preventative actions (CAPAs). This individual will play an integral role collaborating within a cross-functional team that includes Manufacturing, Quality Assurance, Process Engineering, Process Development, Analytical Sciences, Quality Sciences, Quality Control, Supply Chain, and Regulatory Affairs.
Responsibilities
Manage deviation investigations, including assembling investigation teams, leading root cause analysis, development of CAPAs, and compliant documentation of all findings.
Drive improvements to the investigation process
Defend investigations to regulatory inspectors and internal auditors
Present complex topics clearly to large and small groups at all levels in the company
Build effective relationships across functions
Clear and concise technical writing
Auto req ID
478714BR
Minimum Education Required
High School/GED
Job_Category
Manufacturing
Additional Qualifications/Responsibilities
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a go getter with these qualifications.
Basic Qualifications
Doctorate degree
Or
Master’s degree and 2 years of manufacturing experience
Or
Bachelor’s degree and 4 years of manufacturing experience
Or
Associate’s degree and 8 years of manufacturing experience
Or
High school diploma / GED and 10 years of manufacturing experience
Preferred Qualifications
5 years related work experience (manufacturing, process development, or quality assurance) in biotech or pharmaceutical industry with progressively increasing responsibility
Degree in Science or Engineering
Experience leading complex investigations
Demonstrated project management ability
Excellent written and verbal communication skills
Ability to work in a team matrix environment and build relationships with partners
What you can expect from us
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’ll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In Addition To The Base Salary, Amgen Offers a Total Rewards Plan, Based On Eligibility, Comprising Of Health And Welfare Plans For Staff And Eligible Dependents, Financial Plans With Opportunities To Save Towards Retirement Or Other Goals, Work/life Balance, And Career Development Opportunities That May Include
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models, including remote and hybrid work arrangements, where possible
Salary Range
107,545.40USD -145,502.60 USD
City*
Thousand Oaks
State*
California
Job Code
Pharmaceutical Pharmaceutical
Affiliate Sponsor
Amgen
Salary Range
>$100,000
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.
Specialist Manufacturing
What you will do
Let’s do this. Let’s change the world. In this vital role you will investigate deviations in the Amgen Thousand Oaks Manufacturing Clinical Supply Organization, including Drug Substance and Drug Product manufacturing, Supply Chain, Drug Product Assembly/Packaging, Quality Control, and Warehouse Operations. These investigations are aligned with regulatory requirements and include determination of scope, product impact, root cause, and effective corrective/preventative actions (CAPAs). This individual will play an integral role collaborating within a cross-functional team that includes Manufacturing, Quality Assurance, Process Engineering, Process Development, Analytical Sciences, Quality Sciences, Quality Control, Supply Chain, and Regulatory Affairs.
Responsibilities
Manage deviation investigations, including assembling investigation teams, leading root cause analysis, development of CAPAs, and compliant documentation of all findings.
Drive improvements to the investigation process
Defend investigations to regulatory inspectors and internal auditors
Present complex topics clearly to large and small groups at all levels in the company
Build effective relationships across functions
Clear and concise technical writing
Auto req ID
478714BR
Minimum Education Required
High School/GED
Job_Category
Manufacturing
Additional Qualifications/Responsibilities
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a go getter with these qualifications.
Basic Qualifications
Doctorate degree
Or
Master’s degree and 2 years of manufacturing experience
Or
Bachelor’s degree and 4 years of manufacturing experience
Or
Associate’s degree and 8 years of manufacturing experience
Or
High school diploma / GED and 10 years of manufacturing experience
Preferred Qualifications
5 years related work experience (manufacturing, process development, or quality assurance) in biotech or pharmaceutical industry with progressively increasing responsibility
Degree in Science or Engineering
Experience leading complex investigations
Demonstrated project management ability
Excellent written and verbal communication skills
Ability to work in a team matrix environment and build relationships with partners
What you can expect from us
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’ll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In Addition To The Base Salary, Amgen Offers a Total Rewards Plan, Based On Eligibility, Comprising Of Health And Welfare Plans For Staff And Eligible Dependents, Financial Plans With Opportunities To Save Towards Retirement Or Other Goals, Work/life Balance, And Career Development Opportunities That May Include
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models, including remote and hybrid work arrangements, where possible
Salary Range
107,545.40USD -145,502.60 USD
City*
Thousand Oaks
State*
California
Job Code
Pharmaceutical Pharmaceutical
Affiliate Sponsor
Amgen
Salary Range
>$100,000
Salary : $100,000