Specific Job Duties:
- Manage and coordinate Technical Services resources to provide support to manufacturing operations through effective implementation of management, troubleshooting and root cause analysis skills.
- Work closely with multiple departments, including Manufacturing, Maintenance, Quality, and R&D to ensure excellent internal customer service and timely completion of special projects.
- Participate in continuous manufacturing improvements in efficiency, loss reduction and quality.
- Design and implement process controls at critical steps in the manufacturing process.
- Perform tasks safely, with a focus on current Good Manufacturing Practices (cGMP) and current Good Documentation Practices (cGDP), in a fast-paced manufacturing environment.
- Prepare technical documents: technical reports, standard operating procedures, and training materials.
- Contribute to training program as a technical expert.
- Contribute to compliance program as a technical expert.
- Design and perform process optimization studies in conjunction with R&D leadership.
- Support the production of new products and major reformulations in conjunction with R&D leadership.
- Participate in planning and manufacturing led meetings related to production, quality and compliance.
- Perform all other tasks as assigned by Threshold management.
Minimum Qualifications Required:
- Bachelor’s degree in engineering or scientific discipline.
- Expertise in tablet compression, encapsulation, blending, granulation and milling technologies.
- Formulation and product development experience with solid oral dose products.
- 10 years of experience in a cGMP manufacturing environment, particularly for the development and production of tablet and capsule products.
- 2 years of leadership experience with manufacturing or technical teams.
- Excellent documentation and technical writing skills; experienced with Good Documentation Practices.
- Skilled in basic computer use and software (i.e. Windows, MS Word, MS Excel).
- Exceptional initiative and effective troubleshooting and problem solving skills.
- Ability to multitask and make sound decisions in a fast-paced dynamic working environment.
Skills and/or Training Preferred But Not Required:
- Familiarity with Quality by Design (QbD) principles of the Food and Drug Administration (FDA) for product development.
- Experience with formal design of experiments methodology.
- Experience with the design and implementation of process analytical technology (PAT).
- Experience with equipment installation and qualification.
- Experience leading teams of varying backgrounds, experiences, and education levels.
- MS or PhD in engineering or a science related field.
- Bilingual (Spanish and English).
- Experience with setup and operation of manufacturing equipment (tablet press, encapsulator, roller compaction, wet granulation).
- Experience with tablet and capsule formulas and ingredients.
- Experience with testing, data recording and analysis.
- Experience with tablet press and/or encapsulation tooling and parts.
- Extensive experience in nutritional supplement or pharmaceutical industry outside of manufacturing or development roles.
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.