The Senior Scientist will be responsible for conducting and/or managing performance testing on raw materials, drug substance intermediates, active pharmaceutical ingredients (API), and finished dosage forms (FDF). Additional responsibilities will include leading the creation of standard operating procedures for new or existing analytical equipment, performing IQ/PQ/OQ, troubleshooting, preventative maintenance and calibration of analytical laboratory equipment, and independently lead method development and the interpretation of data. The Scientist 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 Responsibilities and Accountabilities:
- Perform duties on site, on time, and within the Company’s normal business hours listed in the Employee Handbook. Facilitate frequent interactions with co-workers and conduct timely problem-solving meetings necessary to address critical and emerging work issues. Present a positive attitude to create and maintain productive working relationships with fellow employees and vendors.
- Perform analytical testing in support of Novan’s development objectives including raw materials, in-process samples, and finished products.
- Implement GXP practices when appropriate and adhere to Novan’s Quality Systems/applicable regulatory guidelines in all work performed and author relevant technical documents, such as protocols, reports, and technical memoranda.
- Collaborate with, mentor, and train less experienced scientists and may be responsible for supervising direct reports.
- Participate in cross-functional project teams and effectively communicate results in a timely and precise manner.
- Follow best laboratories practices, according to Novan’s procedures, including maintaining updated and accurate laboratory notebooks.
- Lead the development and validation of new test methods with minimal oversight.
- Perform other duties as assigned.
- MS or PhD in chemistry, chemical engineering, or a related discipline preferred.
- Typically, MS with 8 to 15 years or PhD with at least 3 to 10 years of experience in the pharmaceutical industry directly relevant to the instrumentation/responsibilities of the position.
- Practical experience in most of the following instrumentation and techniques are required: liquid chromatography (HPLC/UPLC), mass spectrometry, gas chromatography, ion chromatography, Fourier Transform Infrared Spectroscopy, ultraviolet to visible spectroscopy, viscometry, potentiometry (pH titrations), particle size analyzers, basic wet chemistry, coulometric Karl Fischer titrations and nitric oxide detection.
- Experience with Statistical software such as JMP is desirable.
- Experience with a chromatography data system (CDS) such as Empower is required.
- Self-motivated team player with a strong work ethic, exceptional interpersonal skills, and ability to make decisions independently. Excellent written and verbal communication with the ability to present results in a clear, precise, and timely manner.
- Ability to multi-task and function effectively in an interrupt-driven and fast-paced work environment.
- Expected to lead projects and interact with external clients/contractors/vendors while adhering to timelines and focused on clear company deliverables.
- Must possess a thorough understanding of the theory and practice behind analytical methodology including, but not limited to chromatography, spectroscopy, and titrations.
- Experience with FDA and ICH Guidelines is required.
- Ability to effectively supervise and develop less experienced scientists. Strong computer skills with proficiency using MS Office software Excel, Word, Outlook, and PowerPoint are required.
- The qualified applicant shall demonstrate: a) sound scientific reasoning; b) progressive learning agility; c) versatility or being capable of doing many things competently; and, d) resilience from a disappointment or setback.
- Values achieving milestones, including team and company goals.
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 20 pounds. There will be an occasional requirement to work outside of normal business hours, consistent with other laboratory positions. Some travel may be required (5%).
The typical laboratory environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, use of hands and fingers (i.e. sample preparation and instrument operation) and occasional lifting up to 40 pounds. Safe handling, use, and disposal of chemicals and other hazardous materials is required.
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 actively seeks candidates from diverse backgrounds including women, communities of color, the LGBT community, and people with disabilities.