Company Summary
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 theng material for the products Prolacta sells.
Mission Statement
We discover, develop, and deliver life-changing solutions for critically ill babies and other vulnerable patients. We achieve this through innovative human milk research and leadership in quality and safety.
Vision Statement
Giving babies a brighter future by unlocking the biological power of human milk
Benefits and OpportunitiesCompany Benefits
Prolacta is committed to our employees, which is why we provide outstanding compensation and benefits, including:· Healthcare: Up to 100% medical, dental, and vision insurance for employees and their families – coverageng on the first day.
· Compensation: Competitive, performance-based raises and bonuses; discretionary stock options for all employees; 401(k) company match.
· Work/Life Balance: Four weeks PTO accrued within year 1; generous time off program for new parents; flexible work schedules; reserved parking for expectant moms; electric vehicle charging stations on site; company sponsored social events.
· Professional Development: Committed to helping our employees thrive with educational opportunities and leadership programs such as our Women’s Leadership Development Academy, Athari Council, and Educational Assistance Program.
· Community Engagement: Company-sponsored community service opportunities for our employees and paid time off to volunteer at your child’s school or at other community organizations
Career Opportunities · This position will provide you with the opportunity to develop processes and systems to validate the production and use of our raw materials · Gain experience working in a cGMP laboratory and manufacturing environment · Understand the significance of regulation by undergoing routine audits by a variety of organizations (including federal, local, and international regulations) including but not limited to the FDA · Support method development and validation for methods used in testing of incoming raw materials, raw milk, in-process, final product, stability, environmental monitoring, and facility/utility sampling · the Method Development and Validation Analyst is required to support OOSs (Out of Specification), NCs (Non-Conformance), LIRs (Laboratory Investigation Report), ORs (Observation Report), CAs (Corrective Action) and/or CAPAs (Corrective and Preventative Action), and contract laboratory investigationsPrimary Duties and Responsibilities
· Support development/optimization of new and existing methods required for the testing of raw materials, raw milk, in-process, and final product samples
· Support the preparation of experimental design, analytical method development and analytical method validation protocols and reports
· Writing/reviewing of test specifications and SOPs
· Frequent inter-organizational and outside customer contacts. Represent the organization in providing solutions to difficult technical issues associated with specific projects
· Support data analysis and trending
· Support the investigation and evaluation of non-conformances related to laboratory testing (OOS, NCs, LIRs, SOPs, CAPAs) and other investigations as necessary. Good documentation and investigation skills required
· Understand and follow Quality System Documents relevant to responsibilities, testing, e.g. SOPs
· Understand and follow the Quality System requirements established by Prolacta Bioscience
· Participate in self-inspections and regulatory inspections
· Drive department goals/objectives
· Support On-going continuous improvement projects
· Complete other designated tasks, as necessary
Job Requirements and Qualifications Requirements · BS in Biology, Biochemistry, Biotechnology, Microbiology, Chemical Engineering, Chemistry or other applicable related fields · Minimum of 2 years with BS (1 years with advanced degree) 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/microbiology highly desired Qualifications · Working knowledge of method validation according to ICH (International Conference of Harmonization) Q2(R1) · Excellent interpersonal, communication, presentation and organizational skills · Experience working in a laboratory that performs testing within a regulated environment · Working Knowledge of food chemistry/microbiology, specifically milk testing, or infant formula testing preferred · Must be capable of working in a FDA regulated environment Other Knowledge, Skills and Abilities· Strong analytical and problem-solving ability
· Adaptability and a positive attitude
· Ability to work independently and as part of a team
· Attention to detail
· Ability to multi-task
· Self-starter and self-motivated, with the ability to work proactively using own initiative
· Support various QC projects with the design, testing and implementation phases
· Hands-on approach, with a ‘can-do’ attitude
· Proficient in Microsoft Office (e.g. Word, Excel, Outlook, etc.) Ability to enter and manage data within a LIMS system
Work Environment (Location, travel, shift, on-call, etc.) Travel · 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 10% travel may be required. Location · City of Industry, CA · Duarte, CA · Contingent to the needs of the organization Schedule · Monday – Friday 8am – 5pm · FLSA Status: Non – Exempt Direct Reports · None Physical Requirements The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to walk, sit, use hands to finger, handle, or feel and reach, talk or hear. The employee is occasionally required to taste, smell, stoop, kneel, crouch or crawl. Employee will frequently lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, color vision and ability to adjust focus. Sedentary to light work; walking; talking; hearing; repetitive motions; stooping; kneeling; reaching; walking; pushing; pulling; visual acuity to prepare and analyze data and figures, transcribe, view a computer terminal. Disclaimer The above statements are intended to describe the general nature and level of work being performed by people assigned to thisfication. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel sofied. 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.