Careers in MedTech

Job Title

Sr. Process Development Engineer

Company

Allay Therapeutics Inc

Description

Allay Therapeutics is pioneering ultra-sustained analgesic products to transform post-surgical pain management and recuperation for patients and physicians.

We believe an era of stalled innovation for pain management is over. From San Francisco to Singapore, our team has a passion for solving medical challenges that could benefit millions. We pursue our mission with the energy of a dynamic, global team of entrepreneurs, scientists, clinicians and innovators.

Our culture is one of integrity, passion, and curiosity with a deep appreciation for diversity in thought and background.

Position Summary:

We are seeking a person who will play a key role in the development of the manufacturing processes for a suite of unique bioresorbable medicinal implant products. This will include process development, equipment design, sourcing and support. In addition, this person will support the development of product requirements and test requirements associated with the development of new manufacturing processes. This position will support and cultivate the relationship with part vendors, manual and automation equipment suppliers, and contract manufacturing organizations. This person will also provide cross-functional support for new product introductions to the R&D and Quality teams.

Responsibilities:

  • Design and develop processes to optimize efficient process flow, reduce process or product variability and improve process capability.
  • Develop scale-up processes and commercialization, including automation, requirements to align with company and project goals.
  • Plan, execute, supervise and document process trials in laboratories, pilot plants or vendors’ facilities.
  • Develop, verify and validate product requirements from process development to successful commercialization.
  • Research and recommend new technologies for the production to develop for process efficiency improvement, COGS reduction, quality improvements and product performance optimization.
  • Assist with the design and selection of tooling and production equipment for successful execution of the Manufacturing Strategy
  • Ensure production processes and capabilities align with quality policy and company goals.
  • Write or review requirements documents, qualification protocols, validation reports, drawings, bills of materials and functional and design specifications.
  • Define manufacturing problems, collect data, establish facts, draw conclusions and establish action plans for timely resolution of issues utilizing root cause analysis techniques.
  • Participate in evaluations, design reviews, product and process FMEAs and testing of new products or processes.
  • Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.

Job Specifications:

  • Education:
  • B.S. degree in Manufacturing Engineering, Mechanical Engineer, Bioengineering, Industrial Engineering or equivalent

Experience:

  • 5+ years in process development in the pharmaceutical industry
  • 2+ years of medical product process development in manufacturing under design controls
  • Develop new and scaled processes, including automation, for batch processing of pharmaceutical grade materials.
  • Pharmaceutical batch processing, medical device assembly, and drug filling applications experience is preferred.
  • Experience with planetary mixers, plastics extrusion, food processing or other pharma related batch processing equipment.
  • Overall understanding of ingredient mixing, storage, batching and quality standards.
  • Working in a start-up environment developing processes for unique first-generation products.
  • Experience with software programs such as SolidWorks CAD program, product lifecycle systems and resource planning tools.
  • Application of cost saving techniques in a manufacturing environment such as Six Sigma, Lean, 5S, Kaizen tools.
  • Quality systems for manufacturing, such as Non-Conformances, Engineering Change Orders, CAPA and Deviation processes

Expertise:

  • Thorough knowledge in the development of pharmaceutical batch processing, automation design
  • FDA CFR 210, 211 and 820 as well as ISO 13485
  • Able to work independently with minimal supervision and able to manage their project deliverables
  • Scale-up of manufacturing processes from manual development line to fully automated commercial capability

Travel Requirements:

Ability to travel about 25-50% of the time, both domestic and international

Published
November 16, 2021
Location
Silicon Valley, CA
Category
Medtech  
Job Type
Only registered members can apply for jobs.
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