ByHeart is an infant nutrition company built from the ground up to deliver real innovation on behalf of babies and parents. Our mission is simple: make the best formula in the world. That’s why we studied the latest breast milk science, worked directly with suppliers we know and trust, set uncompromising quality standards, developed our own small batch blending process, built our own manufacturing facilities, and conducted a groundbreaking clinical trial. Our goal is to create a future where all parents feel amazing about feeding their baby—no matter how they do it.
When we launched our Whole Nutrition Infant Formula in March 2022, we were the first new U.S infant formula manufacturer in 15 years. Since then, we’ve been leading the way in a lot of ways.
We’re…
- The only U.S.-made infant formula to use organic, grass-fed whole milk
- The first and only U.S. infant formula company to add the two most abundant proteins found in breast milk—alpha-lac and lactoferrin—to our ingredients list
- The first infant formula company to receive Clean Label Project’s Purity Award (and we test for 700 contaminants vs the required 400)
- We ran the largest clinical trial by a new infant formula brand in 25 years—clinically proving our benefits vs a leading infant formula like:
- Less spit up
- Softer poops
- Easier digestion
- More efficient weight gain
- Enhanced nutrient absorption
- Longer stretches between nighttime feeds*
With >$250M in funding, we’re shifting the industry forward—and this is just the beginning. Help us build a future where all parents can feel amazing about feeding, by joining our growing team of >275 people that stretches across the country.
We're proud to offer competitive, family-first benefits, including but not limited to:
- Health insurance for the whole family: medical, dental, & vision insurance covered 100%, with 90% coverage for your family.
- Flexible paid time off: plus 12+ company holidays, and 2 floating holidays to use at your discretion!
- 16-weeks of fully-paid parental leave and new parent support: free 1-year supply of formula, cozy feeding suites, and paid pumping time.
- Up to 6% 401(k) Match to help you plan for your future.
- Company equity for every employee: because when we succeed, we succeed together!
Visit our site to learn more, and check out some recent press on ByHeart:
- White House Roundtable: President Biden Meets with Infant Formula Manufacturers
- Business Insider: ByHeart Announces Published Data in a Scholarly Journal on Benefits of The Novel High Quality Protein Blend in Their Groundbreaking Next-Generation Easy to Digest Infant Formula
- Governor Wolf Press Conference: Gov. Wolf highlights state investment in ByHeart, first new formula manufacturer in 15 years
- CBS News: As parents scramble to find baby formula, a new manufacturer is seeing soaring demand
- Forbes: A Startup Wanted To Make A Better Baby Formula. It Took Five Long Years.
*based on data from infants at approximately 4 months of age
Role Description
The Quality Lab Supervisor is responsible for the overall direction and coordination of the microbiological, physical and chemical analysis on raw materials and food products from various stages of the manufacturing process as directed by the Director of Quality and provides assistance to the operations team. Provides support and assistance to the Director of Quality by performing auditing and inspection functions for post-cleanup and sanitation. Accuracy, reliability, and expediency are essential to the successful completion of the duties of a Quality Lab Supervisor.
Reports To: Director of Quality
Location: ByHeart Manufacturing Facility in Portland, OR
Start Date: ASAP
Role Responsibilities
- Manage, Supervise and Coordinate QA Laboratory Personnel and QA Laboratory Activities.
- Responsible for the day-to-day operations of the laboratory and ensuring good laboratory practices are implemented, documented, and sustained
- Direct and coordinate training of QA Lab Technicians in accordance with regulatory guidelines.
- Oversee all chemical and physical analysis (including flavor checks) on product, ingredient and control samples according to laboratory procedures that are performed by the Lab Technicians.
- Understand the concepts of each analysis, anticipate the result and follow through on any deviation.
- Complete Event Reports for non-conforming results
- Oversee Instrument Calibration and preventive maintenance programs as it relates to equipment used in the laboratory.
- Record all product analyses according to laboratory protocols including data entry on a computer system.
- Conduct oversight management for any testing that is outsourced.
- Procure Laboratory and Quality Assurance Supplies
- Clean and maintain all equipment/materials used while keeping the laboratory clean and organized.
- Develop and maintain the Environmental Monitoring Program. Oversight and/or performance of indicator organism testing and collection of environmental samples for 3rd party pathogen analysis.
- Ensure compliance with written procedures.
- Communicate effectively all critical information regarding analysis, procedures, and test results.
- Handwriting must be clearly legible.
- Follow all laboratory and plant GMP and safety procedures according to company guidelines.
- General Plant QA responsibilities may include (but are not limited to): collection and distribution of product and ingredient samples, environmental swabbing, ATP swabbing, air sampling, water sampling, allergen testing, and safety checks.
- Support Customer Complaint Investigations, driving to root cause(s) and effective resolution (corrective actions)
- Track and report on plant quality key metrics and trends & prepares / issues Monthly Quality reports to management on an ongoing basis to ensure transparency.
- Participate in training for plant personnel and visitors/contractors concerning food safety, FSMA and cGMPs.
- Comply with all policies and procedures of BlendHouse and ByHeart.
- Other Duties as Assigned
Skills & Qualifications
- Bachelor’s Degree in Biological Sciences, Food Science or related field is preferred
- Minimum of 2-5 years’ experience in a lab environment with demonstrated leadership experience. Infant Formula or Food manufacturing experience preferred.
- Demonstrated working knowledge of cGMP for Food, as well as good laboratory practices, testing methodologies and manufacturing practices as described in the Code of Federal Regulations (21CFR 106; 107 and 117).
- Competency in performing functions that ensure product quality, safety, and compliance to applicable SOPs and GMP regulations such as data entry, results from assessments, internal audits, CAPA resolutions, and records review
- Must be able to perform analysis, mathematical calculations, and statistical evaluations
- Must be self-disciplined, a team player, and be able to handle emergency situations common to the operation
- Must be able to maintain and display personal cleanliness and follow GMPs as described in company guidelines
- Must be able to write clearly and in an organized fashion
- Must be able to use computer systems including but not limited to ERP System (Deacom), Microsoft Word, Microsoft Excel, PowerPoint, and Doc Control System (QT9)
Physical Requirements
- Ability to lift up to 40 lb (e.g. quality samples, files and supplies).
- Job involves approximately 80% walking/standing and 20% sitting at desk/computer.
- Must be able to work on their feet for extended periods of time
- Must be able to navigate stairs safely.
- Ability to stand for extended periods of time and stoop, bend, kneel, crouch, balance.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
What We Do
Founded in 2016, ByHeart is a fully integrated baby nutrition company dedicated to empowering parents with choice: we want ‘best nutrition for baby’ to be possible for every parent out there.
We build each product from ground up: a team of pediatricians, breastmilk researchers and nutrition experts at the forefront of immune, cognitive, digestive and microbiome health informs our next-to-nature approach; we hand-pick the most wholesome ingredients from partners and farms that we consider family; we take pride in what we put in and in what we keep out of each recipe. On track to become only the 4th fully-integrated, FDA-registered baby nutrition company in the US, we blend in our own facility in Reading, PA with a proprietary small batch process to retain highest ingredient quality. Innovation isn’t easy, but we believe babies – and their parents – deserve a better feeding future.
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