Senior Manager, R&D
hace 6 días
North Brunswick
Job Description Job Description Date 2026 Location 1200 Airport Road, North Brunswick NJ Title Senior Manager, R&D Department Research & Development Reports to VP, Research & Development FLSA (Exempt or Non-Exempt Exempt Role Overview The Senior Manager, R&D will lead multiple product development programs through the research, scale-up, and commercialization process while ensuring adherence to cGMPs, SOPs, FDA requirements, and customer expectations. This individual will provide technical and managerial leadership to the R&D team, oversee development priorities, manage complex projects, and partner closely with Production, Quality, Regulatory, Procurement, and Commercial teams. The Senior Manager, R&D will play a critical role in building and executing integrated development plans, improving department capabilities, mentoring team members, and supporting the company’s strategic growth and innovation initiatives. The duties and responsibilities described are not limited to those outlined and are not intended to be a comprehensive list of all activities, functions, or responsibilities required of the position. Additional duties and responsibilities may be assigned as required. This position requires travel for customer visits and trade shows, both within the United States and internationally, as needed to support business objectives. Areas of Responsibility Leadership & Strategy • Lead and manage the R&D function for new product development, reformulations, and line extensions., • Supervise, coach, and develop a team of formulation scientists, chemists, and R&D associates., • Establish department priorities, allocate resources, and ensure project timelines are achieved., • Collaborate with senior leadership to define product strategy, innovation pipeline, and technical direction., • Drive continuous improvement initiatives related to product development, manufacturing processes, and departmental efficiency., • Serve as the technical lead and subject matter expert for formulation and process development activities. Product Development & Commercialization • Oversee development and commercialization of nutraceutical products including capsules, tablets (monolayer, bilayer, trilayer), beadlets, powders, stick packs, and other specialty dosage forms., • Develop robust formulations and scalable manufacturing processes for dietary supplements and nutraceutical products., • Research and evaluate new ingredients, technologies, excipients, delivery systems, and product claims., • Lead feasibility assessments, prototype development, and technical evaluations for new business opportunities., • Design and direct laboratory experiments, pilot studies, and process optimization activities., • Recommend alternative ingredients and/or process improvements to enhance product quality, manufacturability, cost, and efficiency., • Scale up pre-exhibit and exhibit batches to commercial manufacturing and lead technology transfer from R&D to Production., • Coordinate manufacturing start-up activities and provide floor support during scale-up and initial production runs. Regulatory, Compliance & Documentation • Ensure all product development activities comply with applicable SOPs, FDA regulations, dietary supplement regulations, and Current Good Manufacturing Practices (cGMPs)., • Create, review, and approve SOPs, technical documents, formulas, specifications, validation protocols, and product development reports., • Review batch records, process characterization studies, validation reports, deviations, CAPAs, and investigation reports., • Prepare and review technical briefs, ingredient specifications, risk assessments, and customer-facing development summaries., • Support internal and external audits, customer visits, and regulatory inspections., • Maintain accurate and complete project documentation in accordance with company standards. Cross-Functional Collaboration • Partner closely with Production, Quality Assurance, Quality Control, Regulatory Affairs, Procurement, Supply Chain, Sales, and Marketing teams., • Present technical findings, risks, recommendations, and project status updates to cross-functional teams and leadership., • Identify and proactively communicate development risks, technical issues, and timeline impacts., • Work with vendors and suppliers to identify and qualify new raw materials and technologies., • Support business development and customer meetings by providing technical expertise and formulation recommendations. Additional Responsibilities • Monitor industry trends, emerging ingredients, formulation technologies, and competitive products., • Develop and manage project timelines, budgets, and department metrics., • Assist with annual planning, capital requests, and staffing needs for the R&D department., • Perform other duties and special projects as assigned. Other Responsibilities Including Safety: • Comply with all job-related safety and other training requirements. Requirements Education & Qualification: • Master’s degree in Pharmaceutical Sciences, Chemistry, Food Science, Chemical Engineering, or a related scientific discipline required., • OR a combination of education and experience equivalent to the above requirements., • 8–12+ years of progressive experience in product development, formulation, and commercialization within the nutraceutical, dietary supplement, pharmaceutical, or CDMO industry., • Minimum 3–5 years of leadership or people management experience., • Strong experience with tablets, capsules, powders, beadlets, and related dosage forms., • Proven experience in scaling products from laboratory through commercial manufacturing., • Experience working in a fast-paced contract manufacturing or CDMO environment strongly preferred. Certifications, Licenses, Credentials: • N/A Skills & Ability • Thorough understanding of cGMPs, FDA regulations, dietary supplement regulations, and product development processes., • Strong technical knowledge of formulation science, process development, scale-up, and manufacturing., • Excellent leadership, coaching, and project management skills., • Strong analytical and problem-solving abilities with the ability to interpret complex technical data., • Excellent written and verbal communication skills., • Ability to manage multiple projects simultaneously and meet aggressive timelines., • Strong organizational and cross-functional collaboration skills., • High level of ethics, integrity, professionalism, and confidentiality., • Proficient in Microsoft Office and ERP/document management systems.Able to maintain a professional and positive attitude., • Able to maintain confidentiality and possess a high level of ethics and integrity. Physical Requirements (lifting, etc.): • The employee is frequently required to sit (50%), stand, and walk (50%). Uses hands to finger, handle or feel writing tools and computer keyboard. May reach with hands and arms and infrequently may lift up to 30lbs. Use desk telephone/cell phone to talk and hear or converse with other employees. Work Environment (Office, Warehouse, temperature extremes, etc.): • Primarily located in an office environment where temperatures are controlled for heat and air conditioning. Occasionally walks through warehouse or manufacturing workplace and will be required to wear appropriate PPE for each work area including safety shoes, hair net, safety glasses, face mask, gloves, or disposable jumpsuit. The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all the job responsibilities, duties, skill, or working conditions. In addition, this document does not create an employment contract, implied or otherwise, other than an "at will" relationship. USPL is proud to be an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity or expression, national origin, age, genetic information, disability, protected veteran status, or any other characteristic protected by applicable local, state, or federal law. Benefits And Compensation: Our benefits are designed to help you move forward in your career, and in areas of your life outside of USPL. From health and wellness benefit options including medical, dental, vision, short- and long-term disability, basic life insurance, supplemental life insurance, AD&D insurance. We also offer a matched 401(k) savings plan. Employees have the opportunity to receive compensation in the form of premium pay such as overtime, shift differential, holiday pay, sick time, etc. Newly hired employees receive up to 10 days of vacation in the first year, which grows to 12 days starting the second year of employment. Job Description Acknowledgement I have read and understand the job requirements, responsibilities, and expectations set forth in the job description provided for my position. I attest that I can perform the essential job functions as outlined with or without any reasonable accommodation.
