Process Development Associate II - FDA Compliance

Threshold Enterprises, Ltd.'s picture
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:

  1. Analyze finished batch and ingredient laboratory test data (may include stability data over time).
  2. Analyze manufacturing processes and related process control data.
  3. Correlate laboratory and process data and support the design and implementation of process improvements towards improved manufacturing quality.
  4. Support cross-functional projects (QC, QA, Manufacturing, R&D, Pilot Plant, Maintenance) towards improved product quality and compliance.
  5. Support the design and implementation of a process control master plan.
  6. Design and execute experiments towards process control and process optimization for tablet compression, capsule filling, mixing, wet granulation and dry granulation processes.
  7. Work with manufacturing leads, techs and supervisors to harmonize best practices in various unit operations.
  8. Any tasks assigned by Threshold Management.


Minimum Qualifications Required:

  1. Five years of experience in solid oral dose manufacturing in a cGMP environment, including expertise in in-process testing including:
  2. Tablet weight, thickness, hardness, friability.
  3. Granulation density (bulk and tapped).
  4. Particle Size testing.
  5. Loss on Drying.
  6. Tamping/dosing disk style encapsulation processes.
  7. Experience in data analysis, including ability to summarize and present results.
  8. Must be able communicate effectively and efficiently in English, both written and verbal.
  9. Skilled in basic computer use and software (i.e. Windows, MS Word, MS Excel, Navision).
  10. Must be able to work independently and execute tasks with minimal supervision.

Skills and/or Training Desired:

  1. Bachelors degree (or higher) in scientific or engineering discipline.
  2. Experience with solid oral dose product development and troubleshooting.
  3. Familiarity with Quality by Design (QbD) principles of the FDA for product development.
  4. Experience with formal design of experiments methodology.
  5. Experience with the design and implementation of process analytical technology (PAT).

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Our company is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, veteran status, gender identity or expression, or any other basis protected by local, state or federal law.

This policy applies with regard to all aspects of one’s employment, including hiring, transfer, promotion, compensation, eligibility for benefits and termination.