Duration : months contract
Shift : Regular 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. 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 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 interfacing with various drug product teams to ensure successful technology transfer, with associated documentation, of products. The candidate will assist to establish the 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 :
in scientific or engineering discipline with ‒ years’ experience or in scientific or engineering discipline with ‒ years’ experienceFamiliarity with cGMP and experience in drug product / drug substance manufacturing or process developmentKnowledge of and hands-on experience with various drug product technologiesDisplayed critical thinking, problem solving and independent research skillsAbility to learn new techniques, perform multiple tasks, keep accurate records, follow instructions, and comply with company policiesExcellent project management skills and ability to escalate relevant issues to project lead and line-managementStrong 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 partnersGood computer and organizational skills with strong attention to detailSelf-motivated with a positive attitudeBasic Qualifications :
Master’s degree ORBachelor’s degree and years of experience ORAssociate degree and years of experience ORHigh school diploma / GED and years of experienceMust Have Skill Sets :
Have the ability to author / review / data verify technical documents, such as technical protocols, technical assessments, technical reports and draft standard operating procedures or guideline documents.Ability to work independently and as part of a team with internal and external partners.Ability to learn new techniques, perform multiple tasks, keep accurate records, follow instructions, and comply with company policies.Day to Day Responsibilities :
Apply fundamental engineering and scientific principles to resolve issues and evaluate effects of process improvements, equipment, scale, and raw materialsAssist 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 technologiesSupport technology transfer leads during the transfer of drug products into manufacturing sites (clinical and commercial), including make-a-batch exercises, process parameter riskassessments, process transfer documents, and change control assessmentsSupport development and maintenance of technology transfer tools (clinical and commercial)Effectively communicate results of characterization studies, experimental execution and technology transfer initiativesAuthor / review / data verify technical documents, such as technical protocols, technical assessments, technical reports and draft standard operating procedures or guideline documentsConduct analysis of data generated, including statistical analysis using Minitab, JMP etc.Development of digital tools and models by leveraging data analytics and programming skillsSupport at scale characterization and / or process validation runs as person in plantAbout 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 .
"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"