Job Summary

Candidate will need to be a hands-on, motivated self-starter with strong initiative. Candidate will be responsible for developing and performing various assays for product and process development. Candidate will be required to work both in the laboratory or the pilot plant environment as needed.  In addition, this role will also provide support to the development of new nutritional and drug product development, including support of the clinical material production. 

Primary Duties and Responsibilities

·                     Research and identify biological assays applicable to human milk and human milk components.

·                     Assess and initiate new vendor or contract laboratory qualification for new materials or testing site.

·                     Evaluate, develop, qualify and perform ELISA assays to characterize existing and new products.

·                     Perform analysis of human milk components using various analytical instrument (such as HPAE-PAD and LC/MS), including instrument maintenance and trouble shooting.

·                     Prepare and execute method validation protocol.  Prepare method validation report.

·                     Perform microbiological assays of starting, in-process and final products.

·                     Prepare and implement SOPs through Change Control process.

·                     Support R&D product development, including pilot scale studies, as well as GMP production support.

·                     Support clinical stability studies

·                     Track, order and maintain laboratories supplies to assure analyses can be performed without delay. 

·                     Complete any other designated tasks or assignments, as necessary

Job Requirements and Qualifications

·                     Perform and improve the biological assay based on the vendor product inserts/instruction.

·                     Select, design and develop assay based on scientific publication.

·                     Understanding and experiences with assay 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 interpersonal, communication, presentation, and organizational skills

·                     Working knowledge of food chemistry/microbiology, specifically milk testing, or infant formula testing preferred

·                     Must be capable of working in an FDA regulated environment

·                     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

 

·                     BS in Biology, Biochemistry, Biotechnology, Microbiology, Chemistry or other applicable related fields, or Bachelor’s       Degree with minimum 5 years of experience working in regulated laboratory on related activities

·                     Ability to work independently or as a team to meet deadlines

·                     Detail oriented with critical thinking ability

·                     Adaptability and positive attitude

·                     Ability to multi-task

 

 

Other Knowledge, Skills and Abilities

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

·                     Prior work using HPLC, GC, SDS-PAGE, ELISA, Protein and other biological assays

 

 

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

·         N/A