Vice President of Process Engineering and Manufacturing

Position Summary

Trace-Ability has developed a groundbreaking product in close collaboration with the FDA, called Tracer-QC.  It uniquely addresses an unmet need in radio-pharmaceutical production by complete automation of quality control (QC) with unprecedented simplicity enabled by patented reagent kits.  The product is on the market supported by low-scale pilot production of the kits.  Rapidly growing demand is mandating an immediate industrialization of kit production to fuel expansion of Trace-Ability’s business and achievement of the vision of Tracer-QC becoming the gold standard recognized by the industry and expected by FDA inspectors.  Trace-Ability is looking for a senior MSAT professional to establish and own kit production that can deliver our product with quality and volume demanded by the market.  This is a strategic role reporting directly to the CEO with results-based rapid growth perspective and an attractive compensation package including stock options.  In this position you will have unique opportunities to define the structure of the manufacturing organization and to build your team.  You will have maximum freedom to maneuver without typical organizational barriers present in large companies.  This role is an opportunity to define a legacy of delivering a game-changing product demanded by the FDA.

Trace-Ability summary

Trace-Ability develops and sells highly innovative automated solutions for pharmaceutical quality control in close partnership with the FDA and pharmaceutical companies.  Our front-runner product called Tracer-QC is designed specifically for radio-pharmaceuticals used in medical imaging.  In this industry it uniquely addresses an urgent unmet need created by recently changed FDA regulations.  Our vision is that Tracer-QC will soon become the radio-pharmaceutical industry standard.

The complete solution consists of a stationary instrument, disposable kits and software.  The kit has over 100 individual parts that add up to 4 key individually packaged components:

A – analysis plate designed to be analyzed in plate reader

B – a 96-well plate sealed with liquid reagents in it

C – a 96-well plate sealed under inert atmosphere with lyophilized reagents

D – rack of vials and ampoules with reagents that are incompatible with the 96-well plate or seal

We have launched Tracer-QC while relying on low-scale kit production. The product is in high demand and, in order to keep pace with the orders, we need to “industrialize” kit production with procedures and QMS capable of supporting the quantity and quality of product demanded by our customers.

New Hire RESPONSIBILITIES at Trace-Ability

We are looking for a senior process engineering/manufacturing professional who can take over and own industrialization of kit production (including procedures, organization and QMS) while relying on prior expertise and quick learning curve on Tracer-QC.  This will be a strategic role that will grow quickly with the company as it enables a rapid expansion phase.  Trace-Ability offers competitive compensation and benefits as well as stock options to share the success of the business with key contributors. This is a chance to grow with a dynamic and innovative technology company, and reap the benefits of stock growth commensurate with performance.

Required Qualifications

Track record of products personally taken from R&D to steady production at commercial scale and quality with full ownership of every step (with preference in diagnostic or pharmaceutical fields).

Required experience

1. Development/implementation/validation of product manufacturing procedures
2. Track records of successful products on the market today (for which the candidate has developed production procedures)
3. Quality Management Systems (QMS)
4. Production tooling (e.g., glove box, filler station, automation)
5. Chemical packaging experience
6. Supply Chain Management
7. Manufacturing process/SOP development

Additional Desired Qualifications

1. Team leadership
2. Project Management
3. Liquid handling
4. Quality assurance
5. Routine Production management (inventory, BOM, COGS)
6. PLM system implementation
7. Validation and Verification
8. ISO 9001 or other standards
9. Small company experience
10. Team management
11. Product design to cost
12. Product design for manufacturability
13. Acceptance testing procedure development
14. Engineering background
15. Chemistry background
16. FMEA
17. GMP
18. Pharmaceutical or diagnostic product manufacturing