Job Summary

 

Candidate will need to be a hands-on, motivated self-starter with strong initiative. Candidate will be responsible for development and transfer of assays to be validated for use in Quality Control. Candidate will be required to work both in the method development and QC testing laboratories.   Candidate must be able to work with internal and external laboratories.

 

Primary Duties and Responsibilities

 

·                     Perform human milk oligosaccharides analysis using High Performance Anion Exchange with Pulse Amperometric Detector (HPAE-PAD), including sample preparation, separation, purification. Additionally, HPAE-PAE instrument maintenance and trouble shooting. 

·                     Transfer and develop methods & transfer for GMP production per FDA guidelines, including Standard Operating Procedures preparation. 

·                     Prepare study and validation protocols & summary reports   

·                     Support R&D development of human milk oligosaccharides processes including pilot scale studies, as well as GMP production support. 

·                     Supervise up to 2 entry level laboratory analysts or technicians.

·                     Interpret latest scientific methods discussed in scientific journal articles. 

·                     Use SDS-PAGE, ELISA, Protein and other biological assays to perform duties

·                     Provide analytical support to current QC Laboratory, as needed

Job Requirements and Qualifications

 

·                     Glycan analysis by various methods, e.g. HPAE-PAD, LC-GC, LC-MS, etc.

·                     Method development and validation requirements

·                     Attentive to detail, analytical, and process driven with ability to operate in a complex or matrixed work environment

·                     Good aptitude in equipment functionality and troubleshooting skills

·                     Good time management. 

·                     Strong teamwork, and organizational skills

·                     Good team spirit with a positive attitude

·                     Strong initiative and self-starter

·                     Excellent written and oral communication

·                     Proficiency in Microsoft Office (Power Point, Word, Excel, Access, Visio)

·                     Flexible with work hours which include some mandatory early morning and late night shifts

 

Qualifications

 

·                     Master’s Degree or higher in analytical chemistry, biochemistry or related field with minimum 2 years of experiences working in analytical laboratory, or Bachelor’s Degree with minimum 7 years of experience working in regulated laboratory on related activities

·                     Handles on experience with HPAE-PAD, LC-GC or LC-MS.

·                     Ability to work independently and meet deadlines

·                     Detail oriented with critical thinking ability.

 

Other Knowledge, Skills and Abilities

 

·                     Prior work on purification, identification, and analysis of milk glycans.

·                     Prior research on milk bioactive compounds, including the separation, purification, and quantification of oligosaccharides and bioactive compounds from human milk. 

·                     Prior work using High Performance Anion Exchange with Pulse Amperometric Detector (HPAE-PAD), SDS-PAGE, ELISA, Protein and other biological assays.

·                     Prior experience publishing scientific articles in the peer-reviewed journals. 

 

 

 

 

 

Work Environment (Location, travel, shift, on-call, etc.)

 

Travel

 

<5%

 

Location

 

City of Industry, California

 

Physical Requirements

 

·                     Must be able to perform duties within clean-rooms, requiring to push, pull, and lift equipment up to 25 pounds while full gowned.

·                     Work in -20 degree Celsius for short periods of time to retrieve raw and finished material from the freezer.

 

a.    Activities. How much on-the-job time is spent in the following physical activities? Show the amount of time by checking the appropriate boxes below.

 

Amount of Time

Activity

None

Up to 1/3

1/3 to 2/3

2/3 or more

Stand

 

X

 

 

Walk

 

X

 

 

Sit

 

X

 

 

Talk or hear

 

X

 

 

Use hands to finger, handle or feel

 

 

X

 

Climb or balance

 

X

 

 

Stoop, Kneel, crouch or crawl

 

X

 

 

Reach with hands and arms

 

X

 

 

Taste or smell

X

 

 

 

 

 

 

 

 

 

 

b.    Lifting. Does this job require that weight be lifted or force be exerted? If so, how much and how often? Check the appropriate boxes below.

 

Amount of Time

Activity

None

Up to 1/3

1/3 to 2/3

2/3 or more

Up to 10 pounds

 

 

X

 

Up to 25 pounds

 

X

 

 

Up to 50 pounds

 

X

 

 

Up to 100 pounds

 

X

 

 

More than 100 pounds

X

 

 

 

 

 

Direct Reports

 

·         R&D Intern

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