The Principal Product Development Engineer serves as the formulation and process development subject matter authority in over the counter (OTC) drug and other supplement products, while shaping a portfolio anchored in confectionery science to deliver great-tasting, manufacturable products at pace. This position requires scientific curiosity paired with disciplined development methods, enabling the development of robust line-ready formulations with stage-gate discipline, validation/qualification strategy, change-control rigor, and specification accuracy that make success repeatable. The Principal Product Development Engineer partners cross-functionally with Quality, Operations, Regulatory, and Commercial to orchestrate end-to-end readiness-from feasibility through launch-so innovations are not only novel, but manufacturable and market-ready. Additionally, a key responsibility in this role is mentoring scientists and engineers on confectionary product formulation and manufacturing, while building the systems and standards that amplify the whole team's impact in regulated environments. This role is highly visible across leadership forums and commercialization gates, shaping how the organization scales in a rapidly growing category.
Essential Duties and Responsibilities- Seek and evaluate new ingredients and technologies in pursuit of developing unique product offerings in confectionary OTC and supplement markets, engaging suppliers/vendors, and translating insights into scalable development strategies.
- Translate product briefs and consumer needs into formulation strategies that meet dose targets, sensory attributes, and manufacturability requirements.
- Prepare product samples, test, and analyze physical and sensory attributes (e.g., texture, moisture, pH, and color) against defined acceptance criteria, and link results to stability and scale-up decisions to develop a comprehensive data package.
- Execute Design of Experiments (DOEs) to identify critical drivers (critical process parameters and critical quality attributes; CPP/CQA), define robust parameter windows, and improve scale-up repeatability with clear analysis recommendations.
- Develop strategic partnerships with external industry leaders and internal stakeholders to generate scalable opportunities for product platforms, informing portfolio decisions and manufacturability.
- Engage with cross functional teams including quality, procurement, supply chain, manufacturing, regulatory, and commercial to resolve development and improvement issues, align translation standards (bench/pilot representativeness, sampling), and drive commercialization readiness.
- Establish and maintain soft-chew CPP/CQA strategy across programs, including selection rationale, parameter window development, monitoring requirements, and capability expectations (e.g., variance analysis, and process capability/performance index [Cpk/Ppk] where applicable).
- Set and approve validation standards and acceptance criteria across lifecycle stages and ensure continued process verification (CPV) expectations are met in partnership with Operations/Quality.
- Define and govern phase-/stage-gate technical standards (deliverables, acceptance criteria, escalation triggers) and audit Gate readiness across programs to ensure disciplined decisions and resource allocation.
- Own product stability strategy (risk assessment, study design, acceptance criteria, interpretation) to ensure stability evidence supports scale-up decisions and commercialization readiness.
- Support knowledge capture and organizational knowledge growth via effective data summaries, reports, and presentations.
- Mentor peers and junior scientists on best practices and product knowledge.
- Define and drive best practices; recommend paths going forward; govern change control rigor and document accuracy; lead risk management by setting criteria, reviewing risk matrices, and executing mitigations/escalations; ensure alignment across multiple teams.
People Leader ResponsibilitiesThis position may be required to carry out People Leader responsibilities in accordance with the Company's policies and applicable laws. Responsibilities include:
- Actively supervise, hire, train, schedule, coach, and develop assigned employees.
- Provide task direction to team members and On the Job Training (OJT) for new hires (Onboarding).
- Listen to team members' feedback and resolve/report any issues or conflicts.
- Conduct performance reviews and manage individual performance.
- Recommend personnel actions (pay adjustments, promotions, transfers, terminations).
- Communicate personnel actions following Human Resources and Department Head approval.
- Ensure safety and quality standards are enforced and met.
Required QualificationsEducation & Experience: - Bachelor's degree in a pharmaceutical science, chemical engineering, food science, chemistry, or related scientific discipline.
- 10 years' experience in product development engineering, science, or similar function.
- Experience applying statistical analysis, mathematical modeling, machine learning, data mining, and related techniques to drive solutions.
Knowledge, Skills, & Abilities (KSAs):- Proficient with Microsoft Office and database, project management and ERP software, as well as PLM/documentation stage-gate tools and statistical/visualization software (e.g., DOE/analysis platforms) used to support evidence-based decisions.
- Thorough knowledge of confectionary manufacturing and ingredients.
- Working knowledge of cGMP and Good Laboratory Practices (GLP), with strong documentation discipline, change-control rigor, and the ability to assemble evidence packages that meet Gate expectations in regulated environments.
- Strong business acumen: ability to leverage scientific trends to identify future business opportunities and make data-driven recommendations that balance consumer experience, manufacturability, and commercialization risk/benefit.
- Strong leadership, technical excellence, innovation, analytical, organization, detail orientation, and collaboration abilities; applies systems thinking to build repeatable methods (standards, controls, decision frameworks) that improve consistency across programs.
- Ability to determine best practices, consolidate product knowledge, ensure it is applied across the organization through mentoring peers and junior scientists; elevates team capability through coaching on DOE, evidence standards, and compliant documentation.
- Demonstrated original thinking and creativity; Meets challenges with resourcefulness, generates suggestions for improving work, develops innovative approaches and ideas, and presents ideas and information in a manner that gets others' attention, and applies structured experimentation to explore new product concepts.
- Working knowledge of project management processes and procedures, including stage-gate governance, critical-path/risk management, and readiness criteria to support timely, disciplined decisions.
- Ability to prioritize tasks, utilize time efficiently, and multi-task in an ever changing, fast-paced environment.
- Must have the ability to communicate effectively, both verbally and in writing, with internal staff and management. Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
- Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
- Must be able to demonstrate practical problem solving and trouble shooting skills. Ability to demonstrate practical problem solving and trouble shooting skills. Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
Preferred Qualifications- Master's degree in food science, chemical engineering, biomedical engineering, or related field
- Experience in formulation or product development of OTC or Dietary Supplement or food products.
- Experience developing and commercializing oral drug products under US monograph or NDA regulations.
- Experience with regulatory bodies including FDA and NSF
- Proven formulation and product scale-up experience in a cGMP environment
- Statistical software experience (Minitab, Statgraphics, etc.) with the ability to interpret data and drive action
