- Lets do this. Lets change the world. In this vital role you will work in our Pivotal Drug Product Technologies Group in Thousand Oaks, CA. This group is responsible for late stage drug product formulation and fill/finish process development for various biological modalities (large molecule, RNA, virus). Additionally, the position works on ways to improve how data is analyzed and the use of statistical models to inform decisions throughout drug product development. The Scientist will provide technical and project leadership while integrating information generated by cross functional teams to ensure success through the commercialization process.
location: Newbury Park, California
job type: Contract
salary: $25.00 - 29.85 per hour
work hours: 9 to 5
education: High School
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
- We are all different, yet we all use our unique contributions to serve patients. The process development biotech/pharma professional we seek is a collaborative team-player with these qualifications.
qualifications:
- Masters degree OR Bachelors degree and 2 years of scientific experience Or Associates degree and 4 years of scientific experience Or High school diploma / GED and 6 years of scientific 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).
skills: Good Laboratory Practices (GLP), Investigational New Drug (IND)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
Qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
