Responsible for the development and maintenance of Novan’s supply chain, to ensure efficient and consistent material flow throughout the manufacturing operation, from raw material receipt to CMO Packager/Labeler delivery. Direct and coordinate purchasing, warehousing and inventory management, distribution, and financial forecasting activities to limit costs and improve accuracy, customer service, or safety. Direct the movement, storage, or processing of inventory of raw materials to support cGMP clinical trial manufacturing. This position shall adhere to the Company’s quality system including but not limited to the applicable standards, policies and procedures in the areas of responsibility defined in this job description.
Principal Duties and Responsibilities:
Manage Novan’s supply chain including material procurement (i.e. ordering, receiving, and sample coordination), inventory management, and shipping for Manufacturing and Analytical Services in accordance with cGMP and SOP requirements.
Develop and implement the Master Production, Materials and Capacity Planning and Scheduling to support manufacturing and laboratories.
Forecast, track, and manage Clinical Trial Material manufacturing and supply chain, to include raw materials and laboratory supplies coordination
Work with the Clinical Operations, Pharmaceutical Development, Quality, and Regulatory Affairs departments for clinical trial material planning, forecasting, budgeting, and delivery to ensure uninterrupted supplies throughout the duration of clinical studies.
Participate in the company’s Supplier Management Program, working closely with Quality and other functions to identify and qualify suppliers and ensure adherence to regulatory agencies’ expectations. Develop and implement solutions to analyze purchase performance, supplier quality, and service issues while driving cost savings.
Collaborate with facilities and quality to develop and maintain proper inventory of spare parts to support manufacturing and laboratories.
BA or BS preferred
5-8 plus years of experience in the pharmaceutical/clinical research industry; with at least 3 years of relevant clinical supply chain management/work experience. International clinical supply logistics/management strongly preferred.
APICS/ISM certification preferred (CSCP, CPIM, CPSM) but not required
Thorough knowledge of Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), International Conference on Harmonization (ICH) Guidelines and other applicable global pharmaceutical regulations/guidelines/directives
Comprehensive understanding of the drug development/commercialization process
Demonstrated leadership of continuous improvement initiatives related to supply chain and operations
Strong customer service and cross-functional interpersonal skills with the ability to effectively negotiate the best solution for issues of limited scope
Excellent written and verbal communication with the ability to present results in a clear, precise, and timely manner.
Demonstrated ability to plan and organize and manage multiple projects simultaneously.
Ability to work in a cross-functional team environment and interact with all levels of the organization.
Ability to make sound decisions using problem solving and analysis skills necessary for the role and scope of work performed including implementing process improvements.
Ability to multi-task and function effectively in a fast-paced work environment.
Physical Demands and Work Environment:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
In the typical office environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, use hands and fingers (i.e. typing) and occasional lifting up to 40 pounds. There will be an occasional requirement to work outside of normal business hours.
The typical laboratory environment and requirements include, in addition to the office requirements: regular exposure to fumes or airborne particles, toxic or caustic chemicals, and risk of electrical shock; frequent exposure to risks of radiation and vibration; occasional exposure to wet and/or humid conditions (non-weather) and working near moving mechanical parts.
Novan maintains a drug-free workplace and performs pre-employment and employment substance abuse testing and background verification checks.
Novan, Inc. is an equal opportunity employer and does not discriminate against any employee or applicant for employment. We encourage and foster diversity in the workplace.
About Novan, Inc.
Novan, Inc. is a clinical-stage biotechnology company aiming to leverage nitric oxide’s natural antiviral and immunomodulatory mechanisms of action to treat dermatological and oncovirus-mediated diseases.