FierceBiotech and FiercePharma Jobs
Sr. Quality Control Validation Scientist - Novartis Vaccines and Diagnostics
Dec 20
Location: EMERYVILLE, CACategories: Pharmaceutical
Website: http://appclix.postmasterlx.com/track.html?pid=402881bd1e48ea6f011e4c3375f509f4&source=fiercevaccines
Position Description
Novartis is a world leader in offering medicines to protect health, cure disease and improve well-being. Our goal is to discover, develop and successfully market innovative products to treat patients, ease suffering and to enhance the quality of life. We also seek to provide a return to shareholders that reflects our performance and to adequately reward those who invest ideas and resources in our company.
Located at our global headquarters in Emeryville, California, Novartis Diagnostics is constantly finding revolutionary ways to protect the blood supply, and diagnose and monitor patients. Novartis Diagnostics is actively transforming the landscape of disease prevention, diagnosis, and treatment with state-of-the-art nucleic acid testing and advanced molecular science.
As part of Novartis Corporation, which has operations in 140 countries and on 5 continents; we provide a truly global environment. This means you will have more opportunities to advance your career and to make a real impact around the world.
We invite you to join us!
Reporting to the Director of Quality Control, Novartis Diagnostics the Senior Quality Control Validation Scientist will be responsible for all Analytical Method validation, method development and transfer of new test methods and equipment into Quality Control (QC).
Primary Responsibilities:
• Develops user requirements, writes risk assessments, validation and technical protocols, executes QC test method validation protocols.
• Analyzes data and writes final reports in conjunction with the Tech Ops validation group.
• Works with QA and Tech Ops validation groups to ensure that test method and new equipment validations follow all Novartis requirements.
• Under minimal direction, develop, write and execute test method validations.
• Reviews quality control test method validations to ensure that they meet the current ICH and Novartis Quality module guidelines.
• Writes methods development and method transfer reports for proper traceability purposes and compliance with regulatory requirements
• Supervises staff during validation testing, completes technical review of data and determines the acceptability of testing and development results. Reviews final validation reports to ensure completeness, accuracy and to ensure Novartis requirements are met.
• Develops new methods used in diagnostic antigen testing, improve/optimize existing methods and revalidates test procedures according to a pre-determined schedule. Prepares new and revises existing test method standard operating procedures (SOPS) to ensure consistency and compliance.
• Implement new instruments and test systems to improve efficiency and thru put of the QC laboratory whenever possible.
• Provides technical assistance to QC testing group, manufacturing and validation departments.
• Trains Quality Control Analysts on new methods and instrumentation.
• Work with IT/Validation to implement new instrument software, support, and represent the QC department on software validation projects.
• The position involves working closely with QA validation and reports to the Director of Quality Control.
• Performs other duties and special validation projects as assigned.
Requirements:
o Bachelors in Chemistry, Biology or related field Masters or PhD preferred
o 10 years in a Biological or Pharmaceutical industry with at least 6 years in analytical method validation, preferably in protein chemistry techniques
o Highly experienced in developing and executing analytical test method validation
o Strong leadership skills and experience in management of a cGMP quality control laboratory
o Experience of dealing with Regulatory inspectors from FDA and other health care authorities
o Experience with instrument and software qualification
o Experience in protein and immunochemical techniques such as dye binding and absorbance protein assays
o Experience with the following analytical methods : SDS-PAGE, CE- SDS, Western Blots, Amino Acid Analysis (AAA)
o ELISAs or other immunoassays
o Chromatography techniques such as SEC and RP-HPLC
o Excellent written and communication skills, scientific report writing, proficiency in Word, Excel or other statistical analysis software required. Experience working in a regulated industry (cGMP) and supervision experience is required .
Novartis Vaccines & Diagnotics is a new division of Novartis consisting of two businesses focusing on the development of preventive treatments and tools. Novartis Vaccines is the world’s fifth largest vaccines manufacturer and second-largest of flu vaccines in the United States an an equal opportunity employer.
