Join our growing company! This is a mid-level, full time, position with opportunity to be an active team member at Prolacta. We are looking for an individual that is highly motivated, detail oriented, with strong problem-solving abilities, looking to expand their skills and work on a variety of moderately complex projects providing Research and Development support for the organization.

Who Are You?

Do you love collaborating to get things done? Do you want to contribute to a larger purpose to save the lives of infants in the NICU? Prolacta’s R&D team is seeking a Microbiologist in Method Development and Validation. You will make an impact in the lives of premature infants and their families by choosing to be a part of the Prolacta team.

 

As a Microbiologist, you will be an active member of Prolacta while responsible for designing and executing microbiology experiments to support product development at Prolacta, including testing of incoming raw materials, raw milk, in-process, final product, stability, environmental monitoring, and facility sampling for the Research and Development team. You will be a trusted partner, proactively anticipating business needs to be able to support our team, leaders, and the clients we support.

 

At Prolacta, your opinion matters. The right person for this role has strong analytical and critical thinking skills, is adaptable, and works well both independently and as part of a team. If you are energized by working in a dynamic environment and being a true thought partner, then this is a great role for you.

 

Who Are We- Prolacta Bioscience?

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 Opportunities

Employee 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

·         In collaboration with team members, design and execute the experiments to support product development, regulatory filings, and product claims

• Drive department goals/objectives
• Develop and execute relevant microbial characterization assays
• Develop and execute analytical assays for products

 

Primary Duties and Responsibilities

• 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
• Support On-going continuous improvement projects
• Complete other designated tasks, as necessary
• 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

Job Requirements and Qualifications

Requirements

·         M.S. degree with 5+ years of microbiology experience in an industry setting. Ph.D. Degree in microbiology, biochemistry, molecular biology, or similar is preferred

·         Expertise in execution of microbial identification, testing and validation techniques, including selection strategies, culture techniques and specifications as per USP methods

·         Demonstrated experience in independently designing, executing, and interpreting experiments and communicating experimental results

Qualifications

·         Experience in authoring and reviewing technical documents such as SOPs, protocols and reports Experience with aerobic/anaerobic microbiology techniques

·         Experience culturing and phenotypically characterizing diverse microbes

·         Strong communicator who can successfully collaborate with cross-functional team members and CROs on assay development and execution

·         Analytical and process driven with the ability to operate in a complex or matrixed work environment

·         Working knowledge of method validation according to ICH (International Conference of Harmonization) Q2(R1)

·         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 an FDA regulated environment

·         Proficient in Microsoft Office (e.g. Word, Excel, Outlook, etc.)

·         Ability to enter and manage data within a LIMS system

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

·         Detail oriented with critical thinking skills

Work Environment (Location, travel, shift, on-call, etc.)

Travel

·         Minimal- determined through the needs of the business

Location

·         City of Industry, CA

·         Duarte, CA

Schedule

·         Monday – Friday (HOURS)

·         FLSA Status: Exempt / 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 twenty-five 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.