Position Title: Sr Associate
Work Location: Thousand Oaks, CA 91320
Assignment Duration: 12 Months (possible extension)
Work Schedule: Standard 8-5 local hours (Monday to Friday)
Work Arrangement: Fully Onsite
Position Summary: In this vital role you will work in our Pivotal Drug Product Technologies Group in Thousand Oaks, CA.
Key Responsibilities:

• Plan, design, execute, and document laboratory studies related to formulation and fill/finish process development in support of product commercialization and life cycle management
• Work independently, taking ownership of projects and self-managing work packages with appropriate communication and partner concern.
• Plan, design, execute and document laboratory studies related to formulation and fill/finish process development in support of product commercialization and life cycle management.
• Apply basic science/engineering skills and first principle modeling to solve technical problems
• Participate in Drug Product Commercialization Teams responsible for conducting process development on pipeline products, as well as, supporting commercial products in lifecycle management
• Perform data analysis using advanced statistical/analytical techniques with a proficiency in statistical analysis software
• Provide support, as needed, to clinical and commercial fill/finish manufacturing operations through process capability analysis, troubleshooting, root cause analysis, and product impact assessments for non-conformance investigations and process changes/improvements
• Author and review guideline documents, technical protocols, reports, product impact assessments, and regulatory sections in support of IND and marketing application submissions
• Deliver progress reports and presentations to ensure management awareness and engagement of the current status, advancement, and future program functional needs
• Ability to travel domestically and internationally up to 10% of the time

Qualifications & Experience:

• Degree in Engineering, Chemistry, Pharmaceutics, Materials Science, or related discipline.
• 2+ years of relevant lab experience.
• Understanding of physical/chemical stability of proteins.
• Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with procedures and policies.
• Proficient computer skills.
• Self-motivation, adaptability and a positive attitude.
• Critical thinking, problem solving, and independent research skills.
• Good organizational skills with strong attention to detail.
• Excellent communication (oral and written).
• Master’s degree OR Bachelor’s degree and 2 years of scientific experience Or Associate’s degree and 4 years of scientific experience Or High school diploma / GED and 6 years of scientific experience

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 26.00/hr.