Director, Analytical Research and Development Characterization

Founded in 2000, Tris Pharma, Inc. (www.trispharma.com) is the 3rd largest specialty pharmaceutical company in the United States. With our intense focus on the application of physical chemistry in biological systems, coupled with the requirements of manufacturing and market demands, we have grown our employee base over 250% in the past three years. Specifically, we are engaged in research, development, and manufacturing of both OTC and Rx branded products and specialty generic products. Our mission is to understand the science driving the delivery of drugs into the human body; develop and bring to market products that add value to our customers and patients and provide a benefit to our company, employees and society at large. To support our continued growth Tris is expanding the AR&D team in Monmouth Junction, NJ and has an opening for an experienced Associate Director / Director, Analytical Research and Development (AR&D) Characterization.

The Associate Director / Director, Analytical Research and Development (AR&D) Characterization leads and manages the Analytical R&D laboratory and provides scientific leadership for all method development, formulation support and physical characterization activities following proper analytical methods, protocols, Standard Operating Procedures (SOPs) and company policies while maintaining adherence to current industry standards (current Good Manufacturing Practices (cGMPs), Good Laboratory Practices (GLPs), etc.) in order to meet project timelines, ensure method robustness and facilitate sound product understanding. 

The incumbent forecasts project timelines and develops approaches and goals for analytical deliverables as per project priorities. She/he also reviews scientific, technical and regulatory packages and provides technical guidance within and outside R&D for due diligence, regulatory and quality matters and represents AR&D in cross-functional discussions, issue resolutions and decisions. 

ESSENTIAL FUNCTIONS 

Primary duties/responsibilities

• Ensures compliance with all cGMP, Food and Drug Administration (FDA), Drug Enforcement Agency (DEA), and Occupational Safety and Health Administration (OSHA) regulations, as well as all applicable company compliance guidelines, standards and objectives

• Directs Analytical R&D and provides scientific leadership for all method development, formulation support and physical characterization activities to meet project timelines, ensure method robustness and facilitate sound product understanding; Forecasts project timelines and develops approaches and goals for analytical deliverables as per project priorities in collaboration with Product Development; Represents Analytical R&D team in cross-functional discussions, issue resolutions and decisions; Coordinates and assigns Analytical R&D resources to meet workload demands

• Directs experimental designs and execution of physical characterization for raw materials, in process materials and finished products to facilitate full product understanding; Ensures sound research into literature and critical data and statistical analysis are performed 

• Oversees method development (and validation, if necessary) for testing of raw materials, drug substances and drug dosage forms; Develops raw materials and drug product specifications 

• Supports trouble shooting, improvements and updates of current commercial analytical method 

• Assists Quality Control (QC)-Investigations, including Corrective Action Preventive Action (CAPAs) and customer complaints to identify root causes

• Prepares/revises, reviews and/or approves test methods/procedures, technical reports and other relevant scientific information packages for internal and external use by the Company; Writes and/or revises SOPs

• Conducts due diligence pertinent to analytical for products/assets (brand/generic) being 

• Manages, mentors, coaches and develops direct reports

KNOWLEDGE/SKILLS/ABILITIES REQUIRED

· Masters Degree in a scientific discipline AND minimum 15 years related analytical laboratory experience in the pharmaceutical or biotechnology industry in positions of increasing technical and leadership responsibility (including minimum 5 years managerial experience) OR Ph.D. in a scientific discipline AND minimum 10 years related analytical laboratory experience in the pharmaceutical or biotechnology industry in positions of increasing technical and leadership responsibility (including minimum 5 years managerial experience). 

• In depth, hands on experience and understanding of analytical instrumentation, methodology and principals including: High Pressure Liquid Chromatography (HPLC), Gas Chromatography (GC,), Ultra Violet visible spectroscopy (UV/Vis), automatic titration, Infra Red Spectroscopy (IR), Atomic Absorption (AA), etc. in a pharmaceutical or biotechnology laboratory REQUIRED

• In depth, hands on experience and understanding of product formulations, product stability, packaging, and FDA submission methods and practices REQUIRED

• Advanced knowledge of chemistry, physical characterization, pharmaceutical and statistical theories, methods, procedures and applications REQUIRED

• Current working knowledge of cGMPs and GLPs in the pharmaceutical industry REQUIRED

• Hands on experience writing laboratory SOPs, investigations and other types of protocols REQUIRED

• People management experience REQUIRED

Tris Pharma, Inc. offers a highly competitive compensation and benefits package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer.