Summary of Job Duties:

Lead the manufacturing and process development for new products through the design and execution of small-scale pilot batches to scale-up and commercialization. Lead product improvement efforts for existing products. Contribute to manufacturing improvement projects designed to improve quality, efficiency and yields; contribution may include project design, project management and project execution responsibilities. Support New Product Development and Contract Manufacturing functions for products made out of house.

Specific Job Duties:

• Develop new dietary supplement products, from pilot to commercial scale.
  • Formulation review for feasibility and addition of process aids (excipients) to active dietary ingredients.
  • Manufacturing process design
  • Small scale production with process and product evaluation
    • Analysis of intermediate products, in-process controls, and finished bulk products.
  • Support creation of supporting documentation for new products
    • Master manufacturing records
    • Bulk product specifications
    • Product development reports
• Support the New Product Development Program
  • Attend team meetings and provide project updates as needed.
  • Collaborate with internal planning and manufacturing teams to schedule and execute development batches and first commercial scale runs.
  • Collaborate with Contract Manufacturing team and 3rd party suppliers to develop additional products out of house.
    • May include, but not limited to, formulation and process review, alignment with internal specifications and practices, technical support and product evaluation.
  • Support development of associate policies and procedures
• Drive continuous improvement for existing products and processes
  • Improve manufacturability of top products
  • Enhance productivity and quality through the development of critical process parameter targets, ranges and controls.
  • Support collaborative improvement projects with Manufacturing, Maintenance and Quality teams.
• Perform tasks safely, with a focus on current Good Manufacturing Practices (cGMP) and current Good Documentation Practices (cGDP), in a fast-paced manufacturing environment
• Perform all other duties as assigned by Threshold management.

Minimum Qualifications Required:

• Bachelors degree in engineering or scientific discipline.
• Formulation and product development experience in nutritional supplements or closely aligned industry.
• 5 years of experience in a cGMP manufacturing environment.
• Ability to multitask and make sound decisions in a fast-paced, dynamic work environment.
• Effective troubleshooting and problem-solving skills.
• Experience with continuous improvement methodology.
• Experience working in cross-functional teams.
• Skilled in basic computer use and software (i.e. Windows, MS Word, MS Excel).

Skills and/or Training Desired:

• Advanced degree in Nutrition, Food Science, or other biological or physical science discipline.
• Experience with solid oral dosage form development
• Experience with tablet compression, encapsulation, blending and milling manufacturing operations.
• Experience with liquid and semi-solid manufacturing.
• 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.
• Bilingual (Spanish and English).

• NOTICE REQUIREMENTS: This notice is being posted in compliance with the relevant DOL regulations pertaining to the filing of Permanent Alien Labor Certification Applications. Any person may provide documentary evidence bearing on the application to the Certifying Officer of the US DOL holding jurisdiction over the location of the proposed employment to the Department of Labor as follows: U.S. Department of Labor, Employment and Training Administration, Office of Foreign Labor Certification, 200 Constitution Avenue NW, Room N–5311, Washington, DC 20210. This notice is being provided to workers in the place of intended employment by the following means: Posting a clearly visible and unobstructed notice, for at least 10 consecutive business days, in a conspicuous location in the workplace on the bulletin board where the employer’s U.S. workers can readily read the posted notice, including but not limited to locations in the immediate vicinity of the wage and hour notices.

  Apply at Threshold Enterprises, www.thresholdenterprises.com or email resumes to Nicole Laggner, HR, at NicoleL@thresholdent.com or mail to Attn. HR, Threshold Enterprises, Ltd., 27 Janis Way, Scotts Valley, CA 95066.