Job Description:
As the Process Development Associate II-FDA Compliance, it will be your responsibility to review, analyze and correlate laboratory and process control data towards improved product quality; specifically product uniformity and manufacturing repeatability. Support improved productivity through process understanding and control towards right the first-time manufacturing.
Specific Job Duties:
- Analyze finished batch and ingredient laboratory test data (may include stability data over time).
- Analyze manufacturing processes and related process control data.
- Correlate laboratory and process data and support the design and implementation of process improvements towards improved manufacturing quality.
- Support cross-functional projects (QC, QA, Manufacturing, R&D, Pilot Plant, Maintenance) towards improved product quality and compliance.
- Support the design and implementation of a process control master plan.
- Design and execute experiments towards process control and process optimization for tablet compression, capsule filling, mixing, wet granulation and dry granulation processes.
- Work with manufacturing leads, techs and supervisors to harmonize best practices in various unit operations.
- Any tasks assigned by Threshold Management.
Qualifications
Minimum Qualifications Required:
- Five years of experience in solid oral dose manufacturing in a cGMP environment, including expertise in in-process testing including:
- Tablet weight, thickness, hardness, friability.
- Granulation density (bulk and tapped).
- Particle Size testing.
- Loss on Drying.
- Tamping/dosing disk style encapsulation processes.
- Experience in data analysis, including ability to summarize and present results.
- Must be able communicate effectively and efficiently in English, both written and verbal.
- Skilled in basic computer use and software (i.e. Windows, MS Word, MS Excel, Navision).
- Must be able to work independently and execute tasks with minimal supervision.
Skills and/or Training Desired:
- Bachelors degree (or higher) in scientific or engineering discipline.
- Experience with solid oral dose product development and troubleshooting.
- Familiarity with Quality by Design (QbD) principles of the FDA for product development.
- Experience with formal design of experiments methodology.
- Experience with the design and implementation of process analytical technology (PAT).
Compensation/Salary:
DOE
Confidential Job:
0
Last Resume Date:
Friday, July 9, 2021 - 4:00pm