MCS Manufacturing Senior Associate Biopharma JP11845
MCS Manufacturing Senior Associate Biopharma JP11845
Posted on :
11-04-2025
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1 Vacancy
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Monthly Salary
$ 32 - 37
Vacancy
1 Vacancy
Posted on :
11-04-2025
Job Description
Job Title:MCS Manufacturing Senior Associate Biopharma (JP10845
Location:Thousand Oaks CA.
Employment Type: Contract
Business Unit:Manufacturing Systems
Duration:18 months
Rate: $3237/Hr W2
Posting Date:10/03/2023
3 Key Consulting is hiringMCS(Manufacturing and Clinical Supply) Manufacturing Sr. Associatefor a consulting engagement with our direct client a leading global biopharmaceutical company.
Job Description:
In this vital role you will be part of the Manufacturing Systems team which is responsible for supporting manufacturing activities through new product introduction new technology and equipment introduction continual improvement projects supporting the multiproduct facility operation program CAPA ownership and optimization/implementation of single use technologies. The position is within the drug substance supply organization in ATO Building 23 which is a dynamic environment and an important launch point for Amgens pipeline products. The plant manufactures drug substance at all phases of clinical trials through commercial production.
Responsibilities include:
Basic Qualifications:
Masters degree OR
Bachelors degree and 2 years of experience OR
Associates degree and 6 years of experience
Top Must Have Skills:
Interview process:
Webex interviews. Potential for inperson followup.
We invite qualified candidates to sendyour resume to. Ifyou decide that youre not interested in pursuing this position please feel free to look at the other positions on our websitewww.3keyconsulting/careers. You are welcome to also sharethis opportunity withanyone you think might be interested in applying for this role.
Location:Thousand Oaks CA.
Employment Type: Contract
Business Unit:Manufacturing Systems
Duration:18 months
Rate: $3237/Hr W2
Posting Date:10/03/2023
3 Key Consulting is hiringMCS(Manufacturing and Clinical Supply) Manufacturing Sr. Associatefor a consulting engagement with our direct client a leading global biopharmaceutical company.
Job Description:
In this vital role you will be part of the Manufacturing Systems team which is responsible for supporting manufacturing activities through new product introduction new technology and equipment introduction continual improvement projects supporting the multiproduct facility operation program CAPA ownership and optimization/implementation of single use technologies. The position is within the drug substance supply organization in ATO Building 23 which is a dynamic environment and an important launch point for Amgens pipeline products. The plant manufactures drug substance at all phases of clinical trials through commercial production.
Responsibilities include:
- Support manufacturing by providing subjectmatter expertise for drug substance upstream and downstream processes as process owner (PPO) or Singleuse SME.
- Lead projects using project management skills.
- Resolve quick issues and execute function tests to troubleshoot and optimize process.
- Write protocols and reports in support of validation function testing equipment commissioning and qualification and change management.
- Own Quality Records such as CAPA and CAPAEV.
- Available to work various shifts (day swing graves weekends holidays 5x8hrs 4x10hrs) as instructed by the production schedule to execute functiontesting and project tasks with minimal disruption to operations.
- Available to work on site.
- Must be able to work in a clean room environment wearing steel toe shoes full clean room gowning hairnet and gloves when performing all work while following GMP documents (SOPs) with strict adherence to safety and compliance.
- Apply technical process scientific operational and compliance knowledge with analytical troubleshooting skills to support the implementation of new technologies into the plant.
- Demonstrate strategic problemsolving skills and champion continual improvement.
- As Process owner:
o Support operational readiness of new technologies equipment or processes by applying technical process scientific operational and compliance knowledge with project management skills
o Develop/own drug substance manufacturing processes and procedures. Draft and revise GMP manufacturing documents (SOPs Forms). Draft and develop user requirements for new technologies. - As Singleuse SME:
o Support New Product introduction and projects through SUS mapping
o Support manufacturing and quality through the SUS defect/leak triage process perform troubleshooting on the floor initiate investigation and bring leaks and defects to triage
o Initiate EN/SICAR records and follow process to conclusion including working with vendors on investigation.
o Maintain uptodate EN/SICAR/EE trackers and manage or lead small to medium projects
o Understand singleuse material capabilities and user requirements for new technologies.
Basic Qualifications:
Masters degree OR
Bachelors degree and 2 years of experience OR
Associates degree and 6 years of experience
Top Must Have Skills:
- Degree in Engineering or Life Sciences (if not then at least 5 years experience)
- Experience in Drug substance GMP technical support roles GMP manufacturing Engineering Process Development or equivalent.
- Ability to learn quickly selfmonitor and prioritize.
- Previous biopharma industry experience highly preferable
Interview process:
Webex interviews. Potential for inperson followup.
We invite qualified candidates to sendyour resume to. Ifyou decide that youre not interested in pursuing this position please feel free to look at the other positions on our websitewww.3keyconsulting/careers. You are welcome to also sharethis opportunity withanyone you think might be interested in applying for this role.
Regards
3KC Talent Acquisition Team
Required Experience:
Senior IC
Employment Type
Full Time
Key Skills
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