Job Description
Note:
qPCR, and immunoassays - strongly preferred
GMP lab settings - strongly preferred
Microsoft Office (Word, PowerPoint, Excel) - required
Strong communication and teamwork skills - required
Job Details: Bachelors' degree & 2 YOE.
CW Senior Associate role, Process Development Group, Attribute Sciences, EPIC Impurities Team. Performs analytical testing and lab support activities for the analysis of process related impurities to support development of large molecules in the pipeline. We provide essential data to purification scientists regarding clearance of process related impurities and develop methods and transfer them to various analytical laboratories for release testing of clinical and commercial materials.
Ideal candidate:
Basic Qualifications: • Associate's degree in Biology, Chemistry, Biochemistry, Analytical Chemistry, or a related field and 2 years of Scientific experience OR
• Bachelor's degree in Biology, Chemistry, Biochemistry, Analytical Chemistry, or a related field
Preferred Qualifications:
• Experience and expertise with protein assays, especially immunoassays, ELISAs or qPCR.
• Experience in GMP lab setting.
• Experience and expertise with Microsoft Office software: Word, PowerPoint and Excel.
• Enjoys participating in a cohesive, high performing team, establishes effective and adaptable relationships with colleagues, while contributing as an effective independent contributor.
• Communication - establishes and maintains effective communication mechanisms to keep colleagues appropriately advised; bridges communication between individuals, team and other organizational units as necessary.
• Social skills - communicates optimally, using appropriate tact and sensitivity; makes others feel respected, valued and understood.
Responsibilities: • Lab activities:
o Routine testing support for PD DS process related impurity analysis
o Preparation of lab buffers and reagents
o Lab reagent and materials inventory
o Maintenance of critical reagents stocks
o General lab upkeep and equipment maintenance support
• Provides critical evaluation of analytical data and results to support product development analytical testing activities.
o Documentation of assays and laboratory activities in electronic notebook documentation system
o Generating, analyzing, and interpreting analytical data
• Supporting analytical projects involving method development, qualification, and transfer
Skills:
• ELISA, immunoassays and qPCR technologies
• Familiarity with electronic laboratory notebook/record keeping system(s)
• Familiarity with working in a GMP/GxP environment
• Strong Communication skills
• Team player
Day to Day:
• Analyzing routine samples by qPCR and ELISA, data interpretation and reporting,
• Documentation of results and peer review of electronic notebooks.
• Preparation of lab buffers and reagents, maintenance of critical reagents stocks
• Sample, reagent and materials inventory tracking and re-stocking
• General lab upkeep and equipment maintenance support
To perform experiments, organize data and analyze results under minimal supervision. With minimal supervision, plans, conducts or monitors experiments, records and organizes data, analyses results, generates robust and reliable data and/or Ensures that contracted studies are conducted in compliance with the respective protocol and applicable guidelines and regulations.
HOW MIGHT YOU DEFY IMAGINATION?
You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience, and passion to work toward your goals? At ***, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.
What you will do
Let's do this! Let's change the world! In this vital role you will be developing, qualifying and transferring innovative and fit-for-purpose quantitative assays for the measurement of DNA, proteins and other biological analyzes for manufacturing process development. The Senior Associate in Process Development at *** is instrumental in designing, developing, and optimizing manufacturing processes. They are involved in conducting experiments, analyzing results, and implementing process improvements to enhance efficiency and product quality.
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