Quality / R&D Scientist

American Distilling, Inc. - East Hampton, CT (30+ days ago)


Company Overview:

American Distilling Inc. (ADI) is our manufacturing business unit and the world’s largest producer of Distilled Witch Hazel Extracts. We are committed to maintaining our position as the industry leader by supplying our customers with the highest quality, sustainable, Distilled Witch Hazel ingredients with world class scale, capacity, sophistication and standards. Our cosmetic ingredient bases and active pharmaceutical ingredients (APIs) with astringency claims provide efficacy, versatility and safety for many of the world’s most recognized skin care, hair care, eye care and topical OTC drug products.

Our sister company, Dickinson Brands Inc. (DBI) is our Consumer Products (CPG) business unit. As such, DBI is the world’s leading distributor and marketer of witch hazel based products for skin and personal care. Established in 1997, Dickinson Brands brought together the two heritage hallmarks of Dickinson’s® and T.N. Dickinson’s® which were established in the early 1800’s. Today, Dickinson Brands continues to expand on this foundation by bringing to the multi-outlet (food, drug and mass / FDM) retail markets high quality, value-added products that capitalize on the natural healing properties of witch hazel. Our products are carried in all major skincare and first aid retail sets under the Dickinson’s® Original Witch Hazel and TN Dickinson’s® Witch Hazel brands respectively.

The Opportunity:

Our team is comprised of intelligent and innovative individuals who work collaboratively to ensure creativity, success, and global growth. We are currently seeking an individual to become our Quality / R&D Scientist, reporting to our Quality & Regulatory Director. The Scientist will focus on Analytical Development and Quality while working together with different departments including operations and engineering in the management of day to day production as well as the achievement of strategic corporate goals and objectives. This position will have significant impact on research, quality, operations, new products, existing products and competitive products across our retail and industrial divisions.

Our ideal candidate must be an experienced scientist with strong background in method development and implementation. This individual must have specific experience with modern analytical techniques and data generation for regulatory submissions (including generation of reports, SOPs, protocols). This position requires a team player with a strong sense of urgency as the position will involve coaching and mentoring other scientists and leading teams to deliver high standards of quality within tight deadlines and changing priorities. The organized, self-directed professional we seek must have exceptional verbal and written communication and presentation skills as this he/she will be one of the “technical faces” for the company presenting to industry and regulatory professionals. The candidate must be able to plan and manage multiple projects conceptualize innovative solutions to solve challenging technical problems.

The candidate must have in depth knowledge and experience in cGMP, GLP testing lab procedures and related equipment for the purpose of OTC pharmaceutical API product release. This candidate will help further develop the analytical testing laboratory in regards to equipment, staff and SOP’s and will be responsible for overseeing and assisting with laboratory setups, maintenance of equipment and performing other job-related duties.

Responsibilities:

To provide overall technical leadership and support for the quality and regulatory teams in terms of day to day product release testing and ongoing R&D initiatives

  • Oversee, coach, mentor and be technical expert to staff and other departments. Ability to identify and develop talent.
  • Hands-on Experience in various analytical techniques including FTIR, GC, GC/MS, LCMS including methods development, instrument maintenance / trouble-shooting, data analysis
  • Collect, analyze, and interpret lab results for both product release and research
  • Develop and validate new on-site laboratory test methods
  • Identify and address technical and validation gaps in analytical methods and QC testing.
  • Maintain the quality of the technical output in compliance with GLP and/or cGMP/ICH regulations, standards, and guidelines
  • Initiate and direct analytical testing work performed by outside testing laboratories, including the review and maintenance of resulting data.
  • Write SOPs and analysis reports to clearly communicate work to team members and other stakeholders
  • Establish and evaluate stability testing of OTC pharmaceutical and cosmetic products
  • Identify, evaluate and implement new analytical methods, quality control strategies and formulation recommendations for new product offerings.
  • Maintain/repair laboratory instrumentation and associated equipment.
  • Knowledge of compendial standards related to pharmaceutical products & industry.
  • Strong understanding of the regulatory requirements and guidelines applicable to OTC pharmaceuticals – manufacturing, R&D, Laboratory
  • Experience with the development and management of reference standards, is highly desirable.
  • Advise on monograph development and revision strategies.
  • Lead and /or participate in presentations, audits and preparation of responses to customer and regulatory agency questions/audits.
  • Develop process / production improvement recommendations and assist with documentation and implementation
  • Collaborate with cross-functional teams (IT, production, purchasing) to develop and manage systems to improve the collection and flow of product quality data between production and quality teams
  • Provide strategic recommendations for R&D to Quality and Regulatory Director and senior leaders (CEO, President and others)

Attributes of our Desired Candidate:

  • Independent, hands on technical leader with a positive “can do” attitude and “roll up your sleeves” mindset
  • Self-motivated, quick learner who is driven to take initiative and lead by example
  • Must be hands-on in method development/validation as well as operation/maintenance of analytical instruments;
  • Strong mentoring and coaching aptitude; listens effectively, promotes a culture of collaboration and continuous improvement across diverse teams
  • Comfort in an established yet entrepreneurial, fast paced and quickly changing environment
  • Focused on continuous improvement of process and operational flow
  • Excellent intrapersonal, presentation, problem solving and critical thinking skills
  • Ability to multi-task
  • Strong attention to detail, goal oriented and always looking for ways to make improvements

Requirements:

  • Minimum of bachelor’s degree depending upon experience in the pharmaceutical and/or biotech environment of drug production and quality. MS Degree in analytical chemistry, biochemistry, preferred
  • Extensive expertise in GLP and cGMP/ICH regulations
  • Minimum of 8+ years of experience in a structured cGMP organization producing pharmaceutical products
  • ERP system experience (SAP, Infor, Etc.)
  • Proficient with the Microsoft Office Suite, including strong Excel skills and statistical analysis software (Minitab or JMP) experience is a plus

Compensation:

  • Salary Commensurate with experience
  • Excellent Benefits Including:
  • 100% Company Paid Health Insurance
  • Annual Bonus Plan
  • 401k and Profit Sharing

Job Type: Full-time

Experience:

  • Pharmaceutical: 8 years

Required work authorization:

  • United States