Process Development Sr Associate Thousand Oaks, CA
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Job Location:
Thousand Oaks, CA - USA
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
ATTENTION MILITARY AFFILIATED JOB SEEKERS- Our organization works with partner companies to source qualified talent for their open roles. The following position is available toVeterans 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.
Lets do this! Lets change the world!
In this vital role you will be part of our Cleaning Characterization group based in Amgens Thousand Oaks CA.
This group is responsible for the development of cleaning process design supporting new product introduction in Amgen internal manufacturing network for both drug substance and drug product. The cleaning characterization group perform bench scale studies to enable introduction of new molecules manufacturing in Amgen Manufacturing network. The group supports investigation of deviations/non conformances writes technical cleaning evaluation reports and supports plant inspections including Prior Approval Inspections (PAIs).
Job Responsibilities:
Design and perform planned laboratory experiments in assessment of new product cleaning with existing cleaning process.
Help develop new methods apparatus and procedures for bench-scale cleaning characterization work.
Write technical reports assessments and procedures.
Use characterization data to develop key operating parameters (KOPs) testing requirements and acceptance criteria for new product launches in manufacturing.
Work with Quality Engineering and Cleaning Validation leads to implement Cleaning process requirements at full scale.
Write technical reports based on the bench scale studies supporting individual manufacturing site Cleaning validation program.
Lets do this! Lets change the world!
In this vital role you will be part of our Cleaning Characterization group based in Amgens Thousand Oaks CA.
This group is responsible for the development of cleaning process design supporting new product introduction in Amgen internal manufacturing network for both drug substance and drug product. The cleaning characterization group perform bench scale studies to enable introduction of new molecules manufacturing in Amgen Manufacturing network. The group supports investigation of deviations/non conformances writes technical cleaning evaluation reports and supports plant inspections including Prior Approval Inspections (PAIs).
Job Responsibilities:
Design and perform planned laboratory experiments in assessment of new product cleaning with existing cleaning process.
Help develop new methods apparatus and procedures for bench-scale cleaning characterization work.
Write technical reports assessments and procedures.
Use characterization data to develop key operating parameters (KOPs) testing requirements and acceptance criteria for new product launches in manufacturing.
Work with Quality Engineering and Cleaning Validation leads to implement Cleaning process requirements at full scale.
Write technical reports based on the bench scale studies supporting individual manufacturing site Cleaning validation program.
Additional Qualifications/Responsibilities
What we expect of you
We are all different yet we all use our unique contributions to serve patients. The dynamic professional we seek is a motivated curious and collaborative team-player with these qualifications.
Basic Qualifications:
High school diploma / GED and 6 years of Scientific experience OR
Associates degree and 4 years of Scientific experience OR
Bachelors degree and 2 years of Scientific experience OR
Masters degree
Preferred Qualifications:
Masters or Bachelors degree in a scientific field with demonstrated ability in laboratory environment in life science industry.
Design and perform bench-scale experiments and assessment of data/results.
Analytical methods: Total Organic Carbon (TOC) protein assays gel electrophoresis spectroscopic methods Biological Binding Method (Bioassay SPR or ELISA).
Characterization of cleaning process processes for biologicals.
Experience of writing technical reports based on laboratory studies.
Good knowledge of scientific principles methodologies and practices.
Lab methods including handling and dispensing chemicals preparing buffers and operation of common lab equipment such as pH and conductivity meters.
Strong interpersonal skills and ability to communicate with unique background teams.
Strong lab studies management(project management) skills to prioritize the lab studies based on changing priorities.
Good written and verbal communication skills.
What you can expect of 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 well 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
Required Experience:
Senior IC
Key Skills
- Internship
- Coaching
- Information Technology Sales
- Administration Support
- Financial Planning
About Company
VetJobs & Military Spouse Jobs works with our employer partners to source, screen, and move qualified talent to the desktops of the Hiring Managers. Application is a two-step process, so please be patient with the team. When you submit to a position on our site your information will ... View more
