3 Key Consulting, Inc.

Engineer, Drug Product Manufacturing Technologies (JP12916)

3 Key Consulting, Inc.  •  Thousand Oaks, CA (Onsite)  •  18 days ago
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Job Description

Job Title:  Engineer, Drug Product Manufacturing Technologies (JP12916)
Location: Thousand Oaks, CA. 91320
Business Unit: MCS: Commercial Drug Product
Employment Type:  Contract
Duration: 5+ months (with likely extensions)
Rate $38.00 - $42.00
Posting Date: 6/20/2024.
Notes: Only qualified candidates need apply.  Must be local to Thousand Oaks, CA. (can work from home 1-2 days a week).  Masters Degree is HIGHLY PREFERABLE.  Pharmaceutical industry experience is a must. Ideally 2 years of work experience in the Pharmaceutical space.  Must be an independent worker.

3 Key Consulting is hiring!  We are recruiting an Engineer for a consulting engagement with our direct client, a leading global biotechnology company.


As a member of the process development team, the candidate will be focused on supporting senior staff to develop and characterize drug product technologies and manufacturing capabilities, as well as assist in the process validation and technology transfer of multiple products to various aseptic fill finish manufacturing plants and production lines. The candidate will support senior staff in the planning, execution and documentation of characterization, process validation and technology transfer projects. The candidate will be primarily responsible for executing characterization studies and other experiments at the lab scale and production scale to generate technical data packages using complex technology, while organizing data and analyzing results under supervision of senior staff. The candidate will be responsible for liaising with various drug product teams to ensure successful technology transfer, with associated documentation, of client products. The candidate will assist in establishing the experimental design, develop and execute protocols, obtain reproducible and reliable results, analyze and document experimental results, and communicate results to cross functional groups.

Top Must Have Skill Sets:
  • Masters Degree
  • Familiarity with cGMP and experience in drug product / drug substance manufacturing or process development in pharmaceutical industry setting and manufacturing.
  • Knowledge of and hands-on experience with various drug product technologies.
  • Pharmaceutical industry experience.
  • Independent worker.

Day to Day Responsibilities:
  • Apply fundamental engineering and scientific principles to resolve issues and evaluate effects of process improvements, equipment, scale, and raw materials
  • Assist in the design and execution of experiments to characterize and enable implementation of new capabilities and process changes such as filling, lyophilization and analytical technologies
  • Support technology transfer leads during the transfer of drug products into manufacturing sites (clinical and commercial), including make-a-batch exercises, process transfer documents, and change control assessments
  • Support development of technology transfer tools (clinical and commercial)
  • Effectively communicate results of characterization studies, experimental execution and technology transfer initiatives
  • Author/review technical documents, such as technical protocols, technical assessments, technical reports and draft standard operating procedures
  • Conduct analysis of data generated, including statistical analysis using Minitab, JMP etc.
  • Development of digital tools and models by leveraging data analytics and programming skills

Basic Qualifications:
  • Master degree.
  • Degree and 2 years of relevant experience.
  • Educational background in Chemical Engineering, Biomedical Engineering, Biotechnology correlated technical field of study in biotechnology, life sciences or related discipline.
  • Knowledge in scientific principles of freeze/thaw, formulation/mixing, filtration, filling, lyophilization, capping, and visual inspection.
  • Ability to work on multiple projects simultaneously, learn new techniques, keep accurate records, follow SOP’s and instructions in compliance with company policies, and comfortable to operate in a very flexible, agile environment.
  • Ability to independently design and execute characterization studies, author characterization protocols, process transfer documents, application notes and technical reports.
  • Proficiency in technical problem solving, critical thinking, and delivery of technical solutions with some oversight.
  • Strong knowledge of Quality systems and Drug Product Manufacturing (GMP).
  • Demonstrated ability to use interpersonal skills to build strong technical relationships.
  • Self-motivation, adaptability, and a positive attitude.
  • Excellent communication skills, both oral and written.

Red Flags:
  • No pharma experience
  • Must have experiment experience
  • Poor work ethics
  • Not punctual
  • This is not an entry level role **

Interview Process:
Phone screening followed by video calls (panel interviews)

We invite qualified candidates to send your resume to  resumes@3keyconsulting.com  If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to 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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