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.
Prolacta Bioscience is seeking a Laboratory Specialist to provide support daily lab testing of incoming raw milk samples, in-process, finished product and stability samples.
Primary Duties and Responsibilities
· Understand and follow Quality System Documents relevant to responsibilities, testing, e.g. SOPs
· Complete laboratory testing on all samples in an accurate, efficient and timely manner
· Maintain a safe and clean laboratory
· Dispose of hazardous wastes according to Prolacta established procedures.
· Write and/or revise Standard Operating Procedure (SOP)
· Perform raw material and product analyses: DNA sample matching, general microbiological testing, drugs of abuse testing by ELISA, bovine protein testing, proximate (protein, fat, moisture, ash) analysis, mineral analysis
· Operate, maintain and troubleshoot advanced analysis equipment: ABI 3130, Acudairy IR, Thermo iCAP 6200, Dynex DSX, Freezing Point Osmometer, etc.
· Perform environmental monitoring of the manufacturing areas (gowning required) and utilities
· Participate in out-of-specification and other investigations as necessary
· Support development and execution of validation studies and research projects
Job Requirements and Qualifications
· BS in Biology, Biochemistry, Biotechnology, Microbiology, Chemical Engineering; or related discipline
· Minimum of 0-2 years with BS in Pharmaceutical, Biological or Biotech industry; hands-on experience in manufacturing operations or pilot lab / scale-up operations; experience in pharmaceutical scale-up activities, pharmaceutical validations, or extensive laboratory experience in protein chemistry highly desired.
Other Knowledge, Skills and Abilities
· Proficient in Microsoft Office (e.g. Word, Excel, Outlook, etc.)
· Attention to detail
· Ability to work independently and as part of a team
· Self-motivation, adaptability, and a positive attitude
· Ability to multi-task
· Support various QC projects with the design, testing and implementation phases
· Ability to enter and review data with a LIMS system
Work Environment (Location, travel, shift, on-call, etc.)
· This position is required to support testing at both the City of Industry and Duarte Prolacta locations. Travel (car) between locations may be required. Up to 5% travel may be required.
· 4/10 work schedule
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.