Senior Manager R&D Pre-Commercialization
Mooresville, NC 
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Posted 19 days ago
Job Description
Description

We believe being healthy should not require tradeoffs. SCN BestCo is a leading innovator, developer and manufacturer of Vitamin, Mineral & Supplement (VMS), Over-the-Counter (OTC) and prebiotics/probiotics in enjoyable forms such as gummies, lozenges and chews. With over 50 years of excellence, our team leads the way in changing how consumers make healthier choices. With unique food science expertise and proprietary processes, we've pioneered many firsts. Our passion to create new to the world products has guided and continues to be core to our mission of making health and wellness more enjoyable. Come join us and become a part of our winning formula!

The Senior Manager, Research & Development (R&D) Pre-Commercialization leads a technical team focused on expanding the application of confectionary based forms to Over-the-Counter (OTC) products to create the next generation of products. The position is responsible for leading the design of these products and demonstrating that they meet sensory and key performance criteria prior to commercialization. The Senior Manager, R&D Commercialization drives the formulation effort, combining pharmaceutical design principles with confectionary science to develop a portfolio of monograph/New Drug Application (NDA) products.

Essential Duties and Responsibilities

  • Lead the formulation team to combine pharmaceutical and confectionary science to create breakthrough OTC products.
  • Define and deliver the technology solutions needed.
  • Establish program goals, objectives, and plan development activities by interfacing through project management system.
  • Actively manage projects, capturing development activities, managing key risks, addressing any resource gaps, and driving key decisions with the team and leadership.
  • Directly manage the day-to-day activities associated with the formulation team.
  • Provide technical guidance to formulation team and supporting departments.
  • Design products to ensure they meet sensory and regulatory requirements over the shelf life of the product at the target cost.
  • Conduct material and process interaction studies to define the formulation and process conditions necessary to meet regulatory requirements.
  • Execute Design of Experiments (DOEs) to assess critical attributes of ingredients, products, and processes. Capture, analyze, and report data with sound technical recommendations on product and/or processes.
  • Partner with the Analytical Laboratory team to demonstrate the products meet the regulatory requirements including dissolution, stability, etc.
  • Capture the product development process in the appropriate format (e.g., CMC).
  • Collaborate with the Commercialization team to ensure successful technical transfer of the product and that it meets success criteria.
  • Participate in the evaluation of Innovation capabilities; collaborate with internal and external clients to identify opportunities for new product ideas.

People Leader Responsibilities

The Senior Manager, R&D Pre-Commercialization carries out People Leader responsibilities in accordance with the Company's policies and applicable laws. Responsibilities include:

  • Direct employee supervision to include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance, rewarding, and administering corrective actions; and addressing complaints and resolving problems.
  • Facilitate career development discussions, regular project update meetings, day-to-day project coaching and any other support required to ensure groups and individuals deliver in accordance with the business plan and objectives.
  • Lead and develop product development scientists and technicians.

Required Qualifications

Education and Experience:

  • Bachelor's degree in a science discipline that is relevant to pharmaceutical product development (e.g., chemistry, chemical engineering, pharmaceutical sciences, etc.).
  • 10 years of experience in product development or R&D with extensive experience developing and commercializing both oral monograph or NDA drug products.
  • 6 years of experience in people leadership.

Knowledge, Skills, & Abilities (KSAs):

  • Comprehensive knowledge of product development, including formulation, ingredients, ingredient functionality, ingredient interaction, batching, scale-up, project management, food systems (chemistry, micro, quality), manufacturing, supply chain, experimental design, product stability, stability testing, sensory and consumer evaluation.
  • Thorough knowledge of 21 CFR Parts 110, 111, 210 and 211, as well as sensory analysis approaches.
  • Working knowledge of process control and design.
  • Ability to prioritize tasks, utilize time efficiently, and multi-task in an ever changing, fast-paced environment.
  • Agility to apply pharmaceutical insights/ approaches to confectionary forms, to quickly adapt to new challenges and address them.
  • Proven ability to coach, mentor and educate the organization on New Drug Application process to build capability.
  • Strong project management, scientific, and analytical skills.
  • 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 have the ability to communicate effectively, both verbally and in writing, with internal staff and management.
  • Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents.
  • Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
  • Must be able to demonstrate practical problem solving and trouble shooting skills. Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs, musical notes, etc.) in its most difficult phases. Ability to deal with a variety of abstract and concrete variables.

Preferred Qualifications

  • Master's or PhD in a science discipline relevant to pharmaceutical product development (chemistry, chemical engineering, pharmaceutical sciences, etc.).
  • Experience in food science and/or confectionary-based product development.
  • Experience in contract manufacturing and branded products.
  • Advanced experience in Microsoft Office



Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)

 

Job Summary
Company
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Bachelor's Degree
Required Experience
10+ years
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