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; we blend in our own facility in Reading, PA with a proprietary small batch process to retain highest ingredient quality.
On track to become only the 4th fully-integrated, FDA-registered baby nutrition company in the US – and the only new brand with owned manufacturing and direct supplier relationships – we just closed our over-subscribed $90M Series B in July 2021, and are about to launch our first infant formula, with a pipeline of mom and baby nutrition products to follow.
The ByHeart team is comprised of world-class doctors, pediatric researchers, seasoned formula experts, dedicated blendmasters, and passionate parents. Above all, we are people who know that innovation isn’t easy, but babies – and their parents – deserve a better feeding future.
Please visit our site to learn more, and see some recent press on ByHeart:
- ByHeart Completes Largest US Clinical Trial for a New Infant Formula Brand in the Last 25 Years Supporting their Innovation in Baby Nutrition
- Fast Company Feature- Can This Startup Engineer A Better Baby Formula
- ByHeart Announces the Launch of Cluster a First-of-Its-Kind Digital Community to Support All Parents’ Feeding Decisions
- Romper Story – 5 Things to Know About Cluster, A New Kind of Online Community for Parents
- ByHeart Secures 90m Series B Financing and Achieves all of its Clinical Trial endpoints
This position will lead efforts to collect and analyze data that supports quality and regulatory compliance programs to help enhance decision-making for risk management. Provides technical leadership and focus on generating real-time data insights for the quality in order to help shape data strategies for our commercial programs including claim substantiation, certification compliance, contaminant surveillance programs and test monographs (ingredient, packaging, product release [in-process and finished] and stability). Influences quality metrics, opinions, policies and test programs by providing prediction models and statistical analysis that directly contributes to continuous improvement opportunities throughout the commercial data lifecycle.
Reports To: Hilary Sibert
Start Date: January 31, 2022 or prior
- Oversees mass balance reports for ByHeart, ByHeart owned and co-man facilities in support of Track and Trace and Organic certifications compliance
- Creates and presents clearly and precisely on risk assessments for theoretical contribution of potential contaminants introduced at minimum by: ingredients, process and packaging
- Works closely with ByHeart owned and co-man facilities and Suppliers (packaging and ingredients) in commercial data assessment and trends to assist with specification review and adjustment. Follows strict change control to ensures effective and efficient implementation across the organization.
- Assesses and maintains trending of data for supplier ingredients for commercial lots in order to hold supplier accountable for its product integrity
- Active reports out metrics on Ingredient, Packaging, finished product and Analyzes data, draw insights, and present results in a cohesive, intuitive, and simplistic manner to Quality Management
- Reviews commercial stability data and trends nutrient profiles to ensure shelf-life assignments are met.
- Supports procurement in collaboration with Development on suitable alternative materials
- Subject matter expert and thought leader on all aspects of Statistical data analysis
- Independently manages multiple results databases to ensure the integrity of data received from internal and external laboratories
- Examines multiple data sets in order to conduct statistical analysis to determine trends and significant data relationships
- Manages commercial product sampling plans to ensure representative and complete product sets are produced and suitable for intended test monographs.
Skills & Qualifications
- Bachelors degree required, B.S. in Nutrition, Chemistry, Food Science or 7-10 years’ experience in R&D, Product Development, Formulation or Nutrition preferred.
- Minimum of 10 years in infant formula powder manufacturing, or other relevant food industry (e.g. Specialty Dairy Ingredients [Powdered] used in Infant Formula) required.
- Extensive Knowledge of USFDA regulation (e.g., 21CFR106, 107, 113, 117) and proven ability to develop applicable Testing programs that are compliant to regulations and corporate guidelines.
- Experience in gathering data from a variety of sources, analyzing and interpreting complex problems, and utilizing effective decision-making skills to deliver recommendations to Management
- Particularly skilled in statistical analysis and data management
- Excel proficiency required
- Able to examine and interpret relevant data to quickly
- Demonstrated verbal and written communication of technical information.
- Working knowledge of good documentation practices (GDP), good laboratory practices (GLP), and Good Manufacturing Practices (GMP) and quality systems required
- Ability to travel domestically or internationally 15-20%
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.