3 Key Consulting, Inc.

MCS Manufacturing Senior Associate, Biopharma (JP11845)

3 Key Consulting, Inc.  •  $32/hr  •  Thousand Oaks, CA (Onsite)  •  19 days ago
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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 $32-37/Hr W2
Posting Date: 10/03/2023

3 Key Consulting is hiring  MCS (Manufacturing and Clinical Supply) Manufacturing Sr. Associate for a consulting engagement with our direct client, a leading global biopharmaceutical company.


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 Amgen’s pipeline products. The plant manufactures drug substance at all phases of clinical trials through commercial production.

Responsibilities include:
  • Support manufacturing by providing subject-matter expertise for drug substance upstream and downstream processes as process owner (PPO) or Single-use 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 CAPA-EV.
  • Available to work various shifts (day, swing, graves, weekends, holidays, 5x8hrs, 4x10hrs) as instructed by the production schedule to execute function-testing 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 problem-solving 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 Single-use 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 up-to-date EN/SICAR/EE trackers and manage or lead small to medium projects
    o Understand single-use material capabilities and user requirements for new technologies.

Basic Qualifications:
Master’s degree OR
Bachelor’s degree and 2 years of experience OR
Associate’s 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, self-monitor, and prioritize.
  • Previous biopharma industry experience highly preferable

Interview process:
Webex interviews. Potential for in-person follow-up.

We invite qualified candidates to send your resume to  recruiting@3keyconsulting.com  If you decide that you’re not interested in pursuing this position, please feel free to look at the other positions on our website www.3keyconsulting.com/careers. You are welcome to also share this opportunity with anyone you think might be interested in applying for this role.
3 Key Consulting, Inc.

About 3 Key Consulting, Inc.

3Key Consulting specializes in the rapid recruitment and placement of business and IT professional within the life sciences and healthcare industries. With 12 years of experience, 3Key has established a vast network of industry professionals and forged strong partnerships/alliances with key academic institutions across the country to continually develop our business professional and niche skill pipeline.

3KC offers a full suite of staffing solutions including PEO and compliance services. 3KC has several technology and industry domain practices including competencies in business intelligence, healthcare and life sciences.

People, process, and technology are 3 key areas of focus that we carefully examine individually and jointly, in order to deliver on our client's 3 key areas of focus - better, faster and cost effective BI and staffing solutions.

MISSION:

To create a better work experience for our customers, partners and employees through exceptional dedication and performance.

• We make hiring easier

• We build strong teams

• We bring about positive outcomes

VISION:

3 Key Consulting’s responsibility is to continually improve the manner and efficiency in which human resources and businesses are brought together to create value. Our vision is to put programs into action that improve market efficiencies while helping businesses and people be more productive.

Industry
Unknown
Company Size
1-10 employees
Headquarters
Simi Valley, CA
Year Founded
2009
Website
3keyconsulting.com
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