As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Internationally known for creating cutting-edge biopharmaceuticals for patients who live with rare genetic diseases, our partner strives to develop critical therapies for the small population - mostly children - that suffer from near unheard of conditions. If you're looking for an exciting opportunity to make a difference with an established company, this is the position for you!
location: Novato, California
job type: Contract
salary: $26.69 - 39.50 per hour
work hours: 9 to 5
- Perform laboratory testing of the company's drug products and API's
- Analyze and review quality control release and stability testing data of the company's pharmaceutical products at Contract Testing Laboratories (CTLs) and/or Contract Manufacturing Organizations (CMOs)
- Support the preparation of phase-appropriate stability protocols and stability reports for API and drug product in accordance with regulatory requirements and as needed to support clinical trials and regulatory submissions
- Support investigations conducted at CMO/CTL and review and approve out-of-specification (OOS), out-of-trend (OOT) and out-of-expectation (OOE) testing results, deviations.
- Support the transfer of analytical methods to CTL's for gene therapy products. These methods may include HPLC, ELISA, and other methods, such as cell-based potency methods.
- Support continuous improvement in quality systems (procedures and systems) to improve organizational effectiveness, quality assurance compliance, and regulatory and other requirements (cGMP, ICH).
- Work collaboratively with manufacturing/supply chain, quality assurance, regulatory, and project management to ensure timely availability of lot release, stability data, and other required analytical data.
- BS in Molecular Biology, Genetics, Chemistry, Biochemistry, Analytical Chemistry, or a related field (with 0 - 2 years professional experience).
- MS in Molecular Biology, Genetics, Chemistry, Biochemistry, Analytical Chemistry, or a related field (with 0 years professional experience).
- Relevant experience in a Quality Control function at an Analyst or technician level is highly preferred.
- Experience with analytical systems (LIMS, laboratory control systems, stability/release systems) is preferred.
- Basic understanding of regulatory agency (FDA) requirement and international guidance (ICH) for drug substance and product under GMP is required as applied to biologics is preferred.
- Demonstrated experience with passaging cells and cell-based methods is highly preferred. Experience with PCR and molecular biology methodologies is preferred.
- Ability to effectively prioritize and deliver on tight timelines in a fast-paced environment.
- Excellent written and verbal communication skills is required.
- Experience in analytical data systems is preferred.
- Accuracy and attention to detail is required.
- Excellent cross-functional team participation skills.
- Basic problem-solving abilities.
- Ability to be flexible with changing work needs
- Interacts with other functional leaders, project management and QC/AD team personnel
- Interacts with Contract Testing Laboratories, Contract Manufacturing Organizations, consultants and external partners
skills: Quality control, HPLC, PCR, FDA, ICH Regulations, GMP (Good Manufacturing Practice), LIMS (Laboratory Information Management System
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.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
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.