Quality Control Senior Scientist - Torrance, CA | Biospace
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Quality Control Senior Scientist

Bachem

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Location:
Torrance, CA
Posted Date:
8/3/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Doctorate/PhD
Areas of Expertise Desired:
HPLC, Quality Control,

Job Description

The Quality Control Senior Scientist fulfills a critical role in active pharmaceutical ingredients (APIs) manufacturing operations.  This individual performs routine release testing, in-process testing, and stability testing, as well as method development and validation.  In addition, this individual performs special projects such as peptide characterization, impurity identification, and other studies as necessary.  This individual conducts or contributes to investigations and the identification and implementation of corrective actions.  This individual contributes to advances in analytical capabilities for the Quality Control department and to the development of all Quality Control staff members.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES

•   Conduct routine analytical tests (HPLC, amino acid analysis, gas chromatography, elemental analysis, thin layer chromatography, polarimetry, melting point, UV-VIS spectrophotometer, Karl Fischer titration, FT-IR spectroscopy, wet chemistry, etc.)
•   Conduct water and environmental monitoring testing (TOC, pH, conductivity, LAL
Bacterial endotoxin, bioburden, etc.)
•   Independently develop and validate analytical test methods
•   Coordinate, execute and oversee impurity identification and peptide characterization projects for the establishment of specifications and in support of regulatory CMC filings
•   Design and execute studies and experiments based on project assignments and draw conclusions based on data generated
•   Perform mathematical calculations, interpret results and record observations
•   Peer review/2nd checking of data to verify compliance with test procedures, verify calculations, assure compliance with specifications, and identify any abnormalities
•   Initiate and document investigations with the intent of determining root cause.  Identify and implement appropriate corrective actions where needed
•   Perform, track and trend stability study time points and maintain stability records
•   Interact with external test laboratories that provide contract testing services
•   Write standard operating procedures (SOPs), test methods, validation protocols and reports, and technical reports
•   Ensure Quality Control laboratory equipment is properly maintained and calibrated
•   Provide guidance and training of other QC personnel to perform various tests according to procedures
•   Support and participate in internal and external audits and inspections
•   Evaluate, recommend, and implement new analytical technologies and instrumentations for peptide analysis and characterization
•   Provide timely responses to internal and external inquiries
•   Stay abreast of new developments in analytical technologies
•   Contribute to improvement in laboratory operations to increase efficiency and GMP compliance
•   Order supplies and maintain adequate stock of other consumable items

Requirements

Required:

•   PhD in Bioanalytical Chemistry or a related science field with at least 5 years’ experience
•   Academic and industry analytical laboratory experience with focus on peptide and protein analysis
•   Hands on experience with HPLC, GC, UV-VIS, FTIR, MS, and LC-MS
•   Broad knowledge of modern Analytical Chemistry
•   Excellent written and oral communication skills
•   Basic computer knowledge, including Microsoft Word, Excel and PowerPoint
•   Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
•   Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues
•   Detail oriented with the ability to troubleshoot and resolve problems
•   Ability to work independently and manage one’s time
•   Communicate effectively and ability to function well in a team environment