Job Description
Duration: 12 months contract
Shift: Standard working hours
Job Description:
- The ideal candidate for this role should have a bachelor’s degree in any scientific or engineering discipline, though candidates with a fresh master’s degree are also suitable if they bring strong soft skills. They The candidate should possess solid experience with software tools beyond Microsoft Office, like SAP or Smartsheet's, though these can be learned on the job. The candidate doesn't need prior drug product knowledge but should excel in group management, deadline adherence, and meticulous documentation skills.
- This position leans heavily on project development (PD) and project management (PM) skills, with technical expertise expected to develop over time.
- 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 the aseptic fill finish manufacturing plants at Thousand Oaks and which includes various 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 on 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 interfacing with various drug product teams to ensure successful technology transfer, with associated documentation, of products. The candidate will assist in establishing experimental design, develop and execute protocols, obtain reproducible and reliable results, analyze and document experimental results, and communicate results to cross functional groups.
Preferred Qualifications:
- B.S. in scientific or engineering discipline with 1‒3 years’ experience or M.S. in scientific or engineering discipline with 0‒2 years’ experience
- Familiarity with cGMP and experience in drug product / drug substance manufacturing or process development
- Knowledge of and hands-on experience with various drug product technologies
- Displayed critical thinking, problem solving and independent research skills
- Ability to learn new techniques, perform multiple tasks, keep accurate records, follow instructions, and comply with company policies
- Excellent project management skills and ability to escalate relevant issues to project lead and line-management
- Strong cross functional team player with good communication skills (oral and written)
- Ability to work independently and as part of a team with internal and external partners
- Good computer and organizational skills with strong attention to detail
- Self-motivated with a positive attitude
Basic Qualifications:
- Master degree OR
- Bachelor degree and 2 years of experience OR
- Associate degree and 6 years of experience OR
- High school diploma / GED and 8 years of experience
Must Have Skill Sets:
- Knowledge of and hands-on experience with various drug product technologies
- Excellent project management skills and ability to escalate relevant issues to project lead and line-management
- Ability to work independently and as part of a team with internal and external partners
Day to Day Responsibilities:
- Responsibilities include, but are not limited to, the following:
- 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 in order 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 parameter risk assessments, process transfer documents, and change control assessments
- Support development and maintenance of technology transfer tools (clinical and commercial)
- Effectively communicate results of characterization studies, experimental execution and technology transfer initiatives
- Author/review/data verify technical documents, such as technical protocols, technical assessments, technical reports and draft standard operating procedures or guideline documents
- 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
- Support at scale characterization and/or process validation runs as person in plant
About US Tech Solutions:
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.
"US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran"
Thanks and Regards,
Bilal Ahmed
Email: bilal.ahmed@ustechsolutionsinc.com
Internal Job ID: 26-06793