SeattleRecruiter
the smart solution for Seattle jobs

Biologics Quality Control Associate II

Company: SCCA Proton Therapy Center, a ProCure Center
Location: Seattle
Posted on: February 15, 2018

Job Description:

Job ID 10310

Type Regular Full-Time

Company Fred Hutchinson Cancer Research Center

Location US-WA-Seattle

Category Quality

More information about this job

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center (FHCRC), home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. FHCRC's pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, FHCRC houses the nation's first and largest cancer prevention research program, as well as the clinical coordinating center of the Women's Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

The FHCRC Biologics Quality Control laboratory performs in-process, release, and stability testing assays for viral vector, recombinant proteins, and antibody-drug conjugate products manufactured in our GMP Biologics Processing Facility. The group also develops, transfers, and qualifies new analytical methods to support product characterization, process development, and product comparability studies. In addition, the group qualifies instrumentation and equipment to support these activities, and actively supports clinical trial regulatory submissions.

We are searching for a dynamic, organized, and detail-oriented laboratory professional to join our team.

Responsibilities

The Biologics Quality Control Associate II performs analytical methods to support the characterization, release, and stability testing of protein-based therapeutics in a GMP laboratory environment. This position represents Biologics QC throughout the project lifecycle (i.e. initiation, implementation, sun setting) and continuously interacts with laboratory management, project sponsors and/or their representatives. The position performs analytical methods such as SDS-PAGE, IEF, HPLC, ELISAs, and endotoxin, and conducts aseptic procedures ranging from routine environmental monitoring to fill/finish of final products. This position must complete all activities precisely/accurately, and document results appropriately. Additional laboratory responsibilities may include development and transfer of analytical methods to/from internal and external partners. Administrative duties include creation/revision of laboratory quality systems and standard operating procedures, environmental/stability/contract laboratory testing data management and trending, and routine maintenance of the lab to ensure a continued state of regulatory compliance.

Qualifications

Required Skills:
* BS/MS in a biological science with 4+ years w/ BS (2+ years w/ MS) experience in biologics, recombinant protein therapeutics, or similar field.
* Working knowledge of GMPs, 21 CFR Part 11/210/211/600, ICH and USP guidelines.
* Hands-on experience in the performance of one or more of the following protein-based analytical methods for characterization/release/stability (ELISA, HPLC, SDS-PAGE, IEF, cell-based bioassays).
* Demonstrated ability to operate in an aseptic environment (i.e. cell culture, sterile fill/finish, environmental monitoring, etc.).
* Experience in the generation of standard operating procedures, test methods, stability reports, or other documents intended for use in a GxP environment and regulatory filings.
* Excellent verbal and written communication skills with demonstrated ability to work both as an individual contributor and in a dynamic team environment.
Preferred Skills:
* Experience in the transfer, qualification and validation of analytical methods and equipment under FDA/ICH guidelines.
* Familiarity with the administration and conduct of environmental monitoring programs (identification, sample frequency/location, periodic trending reports).
* Knowledge of biologics manufacturing and fill/finish processes.
* Familiarity with data analysis/statistical software packages (e.g. Empower, JMP, Prism, LIMS).

Our Commitment to Diversity

We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We are proud to be an Equal Opportunity and VEVRAA Employer. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability, marital or veteran status, sexual orientation, gender identity, political ideology, or membership in any other legally protected class. We are an Affirmative Action employer. We encourage individuals with diverse backgrounds to apply and desire priority referrals of protected veterans. If due to a disability you need assistance/and or a reasonable accommodation during the application or recruiting process, please send a request to our Employee Services Center at ********************* or by calling ************.

Options

Keywords: SCCA Proton Therapy Center, a ProCure Center, Seattle, Biologics Quality Control Associate II, Other, Seattle, Washington

Click here to apply!

Didn't find what you're looking for? Search again!


I'm looking for
in category
within


Other Other Jobs


SNACK BAR LEAD
Description: University of Washington 13 13 Location Seattle, Washington, United States 13 Salary Not specified 13 Job type Employee 13 Category Administrative / Office,Customer Service,Health Care,Restaurant (more...)
Company: University of Washington
Location: Seattle
Posted on: 02/23/2018

Asphalt/Concrete Lead
Description: With over 35 years of experience, AA Asphalting has become the largest Asphalt and Concrete Restoration Company in the Pacific Northwest. Our customers include Public Utilities, General Contractors, Government (more...)
Company: AA Asphalting
Location: Issaquah
Posted on: 02/23/2018

Uber Eats Part Time Delivery - Bike
Description: Deliver with Uber - Earn on your own schedule:Signing up is quick and easy. Start delivering with Uber Eats today The benefits: br br br ul br li Work on your schedule: Take trips for a few (more...)
Company: Uber
Location: Redmond
Posted on: 02/23/2018


WORK FROM HOME WITH LEGIMATE COMPANY
Description: Health Care Plan Provider: Needs Health Care Plan Agents Family and Individual Health
Company: Richard Packard & Associates
Location: Kirkland
Posted on: 02/23/2018

Maritime Security Officer
Description: American Guard Services is currently accepting applications for Maritime Security Officers. 160 Benefits 160 offered:
Company: American Guard Services
Location: Seattle
Posted on: 02/23/2018

Uber Eats Part Time Delivery - Bike
Description: Deliver with Uber - Earn on your own schedule:Signing up is quick and easy. Start delivering with Uber Eats today The benefits: br br br ul br li Work on your schedule: Take trips for a few (more...)
Company: Uber
Location: Ravensdale
Posted on: 02/23/2018

Customer Experience Associate
Description: Job DescriptionWhat Are We Looking ForWe are looking for 20 superstar customer service representatives to join our team These 1099-MISC positions are 100 work-from-home and are only available to residents (more...)
Company: No More Cubicles LLC
Location: Seattle
Posted on: 02/23/2018

Systems Engineer (Entry Level)
Description: Boeing Commercial Airplanes is seeking a Systems Engineer. This position will be involved in the collaborative approach to assist with analyses, design, development and verification of a lifecycle balanced (more...)
Company: Boeing
Location: Seattle
Posted on: 02/23/2018

Uber Eats Part Time Delivery - Bike
Description: Deliver with Uber - Earn on your own schedule:Signing up is quick and easy. Start delivering with Uber Eats today The benefits: br br br ul br li Work on your schedule: Take trips for a few (more...)
Company: Uber
Location: Woodinville
Posted on: 02/23/2018

Telecommute- PT/FT
Description: Seeking homeworkers for solid healthcare company.
Company: Ameriplan
Location: Bothell
Posted on: 02/23/2018

Log In or Create An Account

Username:
Password:
 

Forgot password?


Find us on Facebook

Find us on LinkedIn

Get the latest Washington jobs by following @recnetWA on Twitter!

Seattle RSS job feeds