Senior Manager, Process Development

Element Biosciences is a multi-disciplinary startup focused on innovating genetic analysis tools for the research and clinical markets. The Company's technology will broaden the end user experience through improved data quality and simplified workflows to benefit discoveries and diagnosis in healthcare.

We are looking for a driven, passionate professional to co-develop our processes with our products.  We look for flexible candidates eager to build an amazing company and launch an amazing product!  The Process Development team is integrated with our technology and product development teams, with a focus on pulling the technology out of the lab and enabling it in Operations.

This role will be working on developing the reagent consumable component of our product.  Our product incorporates cutting-edge technology from synthetic organic, nucleotide, enzyme, and surface chemistry disciplines, which makes this role highly integrative.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:

·         Lead a team of scientists and engineers in the development of manufacturing processes, improvement, and robustness projects, as well as ongoing manufacturing support.

·         Manage team priorities, resource allocations, and execution tracking.

·         Lead the design of experiments, driving execution, data analysis, and presentation of outcomes, making recommendations based on data.

·         Build documentation for user and system requirements, participate in product design and development, and support integration and testing activities.

·         Collaborate with development scientists and engineers to establish protocols and translate to standard operating procedures.

·         Lead complex investigations, troubleshooting product performance issues.

·         Balance short-term needs for commercialization with long-term needs for stability and process control that may include the establishment of data layers, driving business process, and quality management systems.

·         Lead development of supplier partners with a critical eye towards successful component development and product commercialization.

- Other duties as assigned.

REQUIRED SKILLS/ABILITIES

·         Direct management or cross-functional team leadership experience is required.

·         Experimental design and statistical data analysis and visualization (such as JMP or R) are required; additional capabilities with image analysis and scripting are a plus.

·         Experience in pilot/full-production environments, including tech transfer activities, sustaining support, and continuous improvement is required.

·         Experience working directly with vendors and/or contract manufacturers is required.

·         Proficient with method verification, validation, and assay transfer into GXP or regulated environments is a plus

·         Creative and independent thinker; excellent communication skills; good team worker; ability to multitask and work independently; and ability to find creative solutions to problems are required.

·         Knowledge and use of computer software for technology and business purposes are required.

·         Ability to produce high-quality work with great attention to detail in a rapid and efficient manner.

EDUCATION AND EXPERIENCE:

·         Successful candidates will have an educational background in chemical engineering, chemistry, biochemistry, molecular biology, bioengineering, or engineering physics, or similar fields.

·         Typically requires a Bachelor’s degree with more than 7 years experience, OR Masters with 3-5, OR Ph.D. with 1-3 years experience.( an equivalent combination of education and experience may be considered).

·         Experience in both Development (new product introduction) and Operations settings, preferably with experience commercializing products in a fast-paced Biologics, Molecular Biology, or Chemistry environment.

PHYSICAL REQUIREMENTS:

- Must be able to life up to 15 pounds

We are passionate about our mission to develop high performing products to study genomics in an unprecedented flexibility and to understand biology for the improvement of healthcare. We have built a highly efficient product-driven organization where employees can learn, grow and thrive in a challenging but encouraging environment.  We are committed to scientific integrity, collegiality, honesty, objectivity, and openness.   We offer excellent benefits, which include a 401K plan, competitive health benefits, flexible vacation, and equity incentives. 

We foster an environment such that all people are afforded the freedom to pursue their passions without regard to race, color, religion, national or ethnic origin, gender (including pregnancy), sexual orientation, gender identity or expression, age, disability, veteran status or any other characteristics protected by law.