Novan
  • 04-Oct-2017 to 03-Dec-2017 (CST)
  • Morrisville, NC, USA
  • Full Time

Purpose:

 

The Director of Drug Product Development is responsible for drug product formulation, process and device development activities for drug candidates in clinical development in accordance with applicable regulations. This position will provide committed and accountable leadership to advance the Company's formulation science required for the development of innovative pharmaceutical products. Additionally, this position will ensure that appropriate technical strategies and timelines are in place to meet clinical supply and registration needs, and that production, technology transfer and regulatory outcomes meet or exceed industry standards. The Director of Drug Product Development 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:

  1. 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 to address critical work issues.  Present a positive attitude to create and maintain productive working relationships with fellow employees and vendors.
  2. Provide drug product leadership on cross-functional project teams; lead development and implementation of new formulations, container closures and devices. Educate cross-functional team participants in formulation development directives.
  3. Direct outsourced drug product development with Contract Manufacturing Organizations including budget development and invoicing, formulation development, container closure/device development and preparation of Chemistry, Manufacturing and Controls (CMC) programs for drug products in development. Facilitate collaboration with both internal and external drug product analytical teams.  
  4. Oversee drug product CMC aspects of regulatory submissions including collaborating with leadership on the active pharmaceutical ingredient and medical device teams. Serve as CMC leader for formulation development and coordinate related activities from early nonclinical and clinical development through registration.
  5. Lead the assessment of novel formulations and the development of innovative drug product delivery technologies (container closures and devices); including lab-scale and pilot-scale process development. Effective cross-functional collaboration with key stakeholders to recommend proposed product specifications.
  6. Collaborate with internal and external manufacturing  teams to support clinical trial material supply as it pertains to internal process development, scale up and technology transfer and associated manufacturing processes, controls and supply chain.
  7. Ensure cGMP compliance for all documentation relating to production operations including any supporting documents required for regulatory submissions.
  8. Ensure product fulfillment through effective collaboration with internal and external production teams. Develop standard costs, evaluate cost of goods as well as manufacturing standards.
  9. Perform other duties as assigned.

 

Qualifications:

Education:

  • MS or PhD in chemistry, chemical engineering, pharmaceutical sciences or a related discipline required.

Experience:

  • Typically 8 to 15 years of drug product development experience in the pharmaceutical industry with increasing levels of responsibility and demonstrated leadership.
  • Significant direct experience with a proven track record of developing new drug products, container closures and devices from pre-clinical through late-stage clinical development into commercial.
  • Demonstrated excellence leading development in pre-formulation chemistry, dosage form design, characterization, stability studies, and manufacturing processes of gels, ointments and/or semi-solid formulations.
  • Combination drug/device experience preferred.
  • Scale-up, technology transfer and management of outsourced (CMO) clinical and commercial manufacturing required.
  • Working knowledge of packaging and labeling regulatory requirements.
  • Expert knowledge of regulatory requirements and direct experience authoring CMC sections for regulatory submissions including INDs, IMPDs, ANDAs, and NDAs.
  • Direct experience interacting with regulatory agencies (Type B meetings, Type C meetings and inspections).
  • Supervisory experience is required.

 Skills and Abilities:

  • Self-motivated team player with a strong work ethic, exceptional interpersonal skills, and ability to make decisions independently.
  • Excellent written and verbal communication skills with the ability to present results in a clear, precise, and timely manner.
  • Progressive thinker who enjoys participating in an innovative, fast-paced, and creative work environment.
  • Expert knowledge of ICH, FDA and EU guidelines.
  • Exposure and experience to both early and late phase development including scale-up and process validation, technology transfer and scale up. Committed to Good Manufacturing Practices and Quality Systems.
  • Strong project management and ability to effectively lead individuals and teams to complete projects and accomplish goals.
  • Ability to anticipate future trends and engage in new, forward-thinking approaches. A challenger of the "status quo".
  • Ability to forge excellent, collaborative internal and external relationships.
  • Proficiency in MS Office (i.e. Excel, Word and PowerPoint) and a propensity to rapidly assimilate new software applications to improve data analysis and reporting functions.
  • Ability to 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 of hands and fingers (i.e. typing) and occasional lifting up to 20 pounds.

 

Additionally, the typical laboratory environment involves sample preparation and instrument operation and infrequent lifting of up to 40 pounds. There will be an occasional requirement to work outside of normal business hours, consistent with other laboratory positions. Safe handling, use, and disposal of chemicals and other hazardous materials are required.   Some travel may be required (10 15%).

 

Novan, Inc. 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.

Novan
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