Company

Prolacta is the pioneer in human milk-based nutritional products for premature infants in the neonatal intensive care unit (NICU). Prolacta believes that there is no adequate replacement for human breast milk and, as such, we believe infant nutritional products should be human milk-based. As a privately held, scientifically driven company, committed to improving premature infant nutrition, we are using human milk to change the standard of care in the NICU. Prolacta operates and/or owns milk banks that provide the starting material for the products Prolacta sells.

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

Direct Reports

· R&D Intern

Disclaimer

The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

“Prolacta Bioscience, Inc. is an Equal Employment Opportunity Employer.” Prolacta Bioscience, Inc. is committed to a proactive program of affirmative action and diversity development. The Company will continue to recruit, hire, train, and promote into all job levels without regard to race, religion, gender, marital status, familial status, national origin, age, mental or physical disability, sexual orientation, gender identity, source of income, or veteran status.