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
Company Values
· Leads the Industry in Quality and Safety
· Succeed Together
· Advance the Science of Human Milk
· Improve Infant Well-Being
Benefits and OpportunitiesEmployee 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- Becoming an expert in human milk science
- Working with cross functional teams.
Primary Duties and Responsibilities
· Responsible for the maintenance and operation of small-scale and clinical-scale equipment, including lyophilizer, milling/compounding and powder filling.
· Provide key input in engineering design, specification, selection, and lead implementations necessary for bringing in new equipment
· Participate in process and cycle designs/development
· Author, review and implement of corrective actions related to equipment or process deviations
· Use knowledge of PLC control engineering to make necessary changes in process and mechanical control
· Properly document and communicate project progress and findings to all key stakeholders
· Design and prepare procedures, including protocols and reports, for material and technology evaluation, as well as for process improvement and equipment qualification,
· Perform studies in pilot plant or full production scale by following written instruction (equipment setup, data collection, sample submission, sample testing, and others)
· Identify and qualify alternate production supplies to reduce production cost.
· Implement major process, equipment and material changes through Change Control and Document Change Request processes, including the preparation of regulatory submission supporting documents.
· Perform analysis using a statistical software (Minitab) to understand and interpret data, and write summary and technical reports.
· Lead and facilitate technical problem solving session with cross-function team through various DMAIC tools.
- Provide technical solution to engineering team for R&D projects or continuous improvement ideas, assist validation engineer on process validation.
- Knowledge of cGMP and cleanroom system is a must
- Basic knowledge of Six Sigma, DMAIC or Lean principles Knowledge of equipment design and operating principals
- Hands-on experience with process tanks, continuous separators, ultrafiltration, chromatography, pumps in pilot plant or manufacturing environment
- Hands-on experience in continuous improvement project leadership
- 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
· Bachelor of Science in Engineering Discipline (Mechanical/Chemical/Industrial Engineering) or Biological Science, with minimum 5 to 9 years of experience in a similar engineering related field
- 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
· Strong technical understanding of filtration/ultrafiltration process
· Strong understanding of equipment design and operation.
· Positive attitude and motivated Selfr
· Working independently with minimal supervision
· Capable of self-generating and implementing value improvement projects
· Produce and present clear, concise and professionally written communications and presentations
· Must be able to work under pressure, meet deadlines, and be flexible when working on multiple projects simultaneously
· Strong Continuous Improvement and Troubleshooting mindset
· Capable of making quick and sound decisions
· Results oriented
Work Environment (Location, travel, shift, on-call, etc.) Travel · None- subject to change depending on the needs of the business Location · City of Industry, CA 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. This position requires working in a laboratory setting for up to 8 hour shift. Laboratory testing includes the handling and disposal of hazardous materials. Office work will also be required for the analysis/reporting of data, writing/reviewing of reports and SOPs. 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.