Job Summary:Responsible for leading product technology transfer and process scale-up for new and existing thin film and dispensed LCO (Lotion, Cream, Ointment) pharmaceutical products at Aquestive Therapeutics Manufacturing facilities in Portage, IN.
Responsibilities:- Lead New and Continuous Process Improvement Projects, including identification of opportunities, researching literature and vendors for new technologies, preparing/presenting proposals, developing/executing projects, while following appropriate Management of Change (MOCs) methodologies.
- Support day-to-day manufacturing operations as Technical Subject Matter Expert (SME) by investigating and resolving process related issues involving the manufacturing process or equipment/ systems
- Perform process monitoring of identified attributes and process parameters. Identifying trends and appropriate actions to continuously improve the process and product.
- Provides training support as required.
- Supports development of required cleaning processes for equipment trains.
- Prepares documentation for new processes and process improvements including Management of Change (MOCs), Risk Assessments, Batch Records, Engineering Studies (ES) and Standard Operating Procedures (SOPs)
- Prepare Work Orders (WOs), Management of Change (MOCs), Design Specifications (DS), User Requirements Specifications (URS), System Specifications Documents (SSD), Failure Mode and Effect Analysis documents (FMEA) for new system/ processes.
- Develops a plan and leads product technology transfer and scale-up.
- Determines process parameters at Pilot and Commercial Scale.
- Evaluates process parameter variability on Critical Quality Attributes.
- Establishes the product manufacturing control strategy and implements into Batch Records.
- Finalizes the QTPP (Quality Target Product Profile).
- Represents Engineering Subject Matter Expert (SME) in Product Development Teams.
- Support deviation investigations to identify root causes and define corrective and preventive actions (CAPAs).
- Work with and manage outside contractors to provide support to projects.
- Able to perform all duties efficiently and independently with minimal supervision.
- Able to work within and lead in a team environment, consisting of multi-functional groups, to achieve a common goal, while promoting teamwork, timeliness, accuracy and compliance in all activities.
- Able to interact with management and peers within the department, within the plant, within the organization and outside regulatory agencies. The individual must also interact with vendors, sub-contractors and consultants on a routine basis.
Qualifications:- Minimum 4-year degree in Chemical (preferred) or Mechanical Engineering, or equivalent pharmaceutical experience.
- 5-7 years of related experience; Pharmaceutical process development/ manufacturing experience preferred.
- Expertise in troubleshooting manufacturing processes, ideally with mixing and blending systems, thin film coating, packaging and web handling, and liquid dispensing.
- PC literate with standard office applications (Outlook, Word, Excel, PowerPoint, MS Teams) competency.
- Knowledge and experience in cGMPs, CAPA, root-cause analysis, risk assessment and investigation tools and techniques.
- Knowledge and experience in project management, including leading and development of capital funding requests and project management software (MS Project, WRIKE or similar).
- Strong communication skills, both written and verbal, and ability to adapt to changing priorities working both independently and collaboratively with teams, when required.
- This individual may become familiar with proprietary and confidential information in the performance of routine duties. Disclosure of such proprietary and confidential information may have a serious detrimental effect on Aquestive's business and may result in disciplinary or legal consequences.
WORKING ENVIRONMENT/PHYSICAL REQUIREMENTS- This position requires concentrated effort in recording, evaluating and transcribing data, as well as computer work, which can cause mental and/or eye fatigue. The work is performed in a clean environment.
- This position will provide 24-hour support for manufacturing and may be required to work extended hours to support operations or projects.
The above statements are intended to describe the general nature and level of the work being performed by colleagues assigned to this position. This is not intended to be an exhaustive list of all responsibilities, duties, and skills required. Aquestive reserves the right to make changes to the job description whenever necessary.
Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days.
