Novan
  • 13-Apr-2018 to 17-Jun-2018 (CST)
  • Morrisville, NC, USA
  • Full Time

The Production Head is responsible for the safe manufacture of both active pharmaceutical ingredients (APIs) and drug products with an emphasis in GMP documentation skills.  This position will coordinate daily activities among the operators as well as operate and maintain manufacturing equipment and instrumentation necessary to support production processes as described in production batch records.  Additionally, this position will maintain production readiness and assist in deviation and other GMP documentation needs.  The Production Head 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 necessary to address critical and emerging work issues.  Present a positive attitude to create and maintain productive working relationships with fellow employees and vendors.
  2. Coordinate daily activities among the operators
  3. Execute API/Drug Product manufacturing operations in the Company's cGMP facility, including:
    1. Dispense raw materials for manufacture
    2. Operate process reactors, filters and dryers
    3. Operate jet milling equipment
    4. Sample product for release testing
    5. Clean and maintain reactors, filters, and jet milling equipment
    6. Maintain a safe working environment
    7. Observe and follow all safe operation practices
    8. Routinely inspect facility safety equipment
    9. Maintain a clean and clutter-free production environment
  4. Operate and maintain equipment and instrumentation necessary to support manufacture of active pharmaceutical ingredients as described in production batch records in a cGMP facility including:
    1. Conduct preventative maintenance activities, where appropriate
    2. Assist in maintaining equipment records pertaining to PM and calibration activities, and equipment warranties
    3. Author and assist in deviation investigations and all other forms of GMP documentation
    4. Suggest improvements to operations in GMP facility
    5. Document production activities per SOPs and cGMPs
    6. Monitor the environment of the GMP facility by following SOPs for airborne particles, room differential pressures, and sanitation.
    7. Maintain the inventory of consumables and supplies required for GMP production.
  5. Perform documentation for batch records, cleaning protocols, equipment use logs, and equipment status tags and labeling.
  6. Coordinate the cleaning, qualification, calibration, and preventive maintenance of equipment and instrumentation.
  7. Participate in staff meetings and special project teams where required.
  8. Perform other duties as may be assigned from time to time.

 

Qualifications:

Education:

  • Associates or Bachelor's degree or equivalent (degree in sciences strongly preferred).

 

Experience:

  • 10+ years of experience working in a pharmaceutical API/Drug Product production facility - overall level of experience will determine position level.
  • Direct experience with cleaning, maintaining and controlling qualified equipment and instrumentation in a GMP environment.
  • Prior deviation, investigation, and SOP writing experience including ability to perform IQOQs.
  • Knowledge of process chemistry is a plus.

 

Skills:

  • Multifaceted team player who can direct operators as needed as well as fully engage in daily activities.
  • Strong verbal and written communication skills with an ability to work in cross-functional product development and manufacturing teams.
  • Honest, flexible, dependable, self-motivated team player with the demonstrated ability to work independently. Willingness to accept responsibility and work assignments.
  • Knowledge of pharmaceutical industry practices, regulations and requirements preferred.
  • Ability to conduct a wide range of manufacturing efforts in GMP and R&D contexts.
  • Demonstrated critical thinking and strong mathematical skills.
  • Ability to work in a cross-functional team environment and a flexible team-oriented perspective; ability to interact with all levels of the organization with strong interpersonal skills.
  • Effectively prioritizes workload and manages time to complete multiple projects within established timelines and goals with minimal supervision in a fast-paced, interrupt-driven environment.
  • Proficient in MS Office software.

  

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.

 

As part of the regular duties for this job, a candidate must:

  • Be able to wear respiratory protection.
  • Be able to work with various chemicals once given proper protective equipment.
  • Have sufficient dexterity to don and doff clean room clothing over normal work attire.
  • Be able to lift 50 pounds of weight repeatedly and safely.
  • Be capable of operating a computer and sitting for extended periods.

 

In the typical office environment requirements include:  reading, speaking, hearing, close vision, walking, bending, sitting, use hands and fingers (i.e. typing).  There will be requirements to work outside of normal business hours. 

 

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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