Scientist/Engineer, Process & Formulations

Location
Richmond, CA
Salary
Salary starting at $90,000 for experienced candidates.
Posted
Sep 09, 2020
Required Education
Masters Degree/MBA
Position Type
Full time

About:

X-Therma develops novel, convergent chemical technologies in biopreservation to advance the field of regenerative medicine by making available safe and on-demand organs for transplant, engineered tissues, and cell therapies for the patients in need. The Company is devoted to lead innovation that enables global Regenerative Medicines on-demand to improve modern medicine and save, repair & rejuvenate billions of lives from today to eternity. We are a team who is here to improve each other every day. We appreciate talent, and it is X-Therma's mission to satisfy your personal development goal to become better every day, however you define it. We are located in the beautiful and busy SF East Bay area.

Description:

We are seeking an enthusiastic and motivated individual who can excel within the small team dynamic of a startup company, enjoys working on game-changing projects, and thrives under emerging challenges to drive projects to completion. The scientist/engineer serves as a critical component in the product development work at the interface between biology, chemistry, and engineering, and is capable to blend the key attributes of technology development and CMC production. She/he will lead development of products from bench work to actively participating in strategic business planning as it relates to product development technical challenges. The scientist/engineer will lead a small group of junior level scientists and manage internal R&D and CMC as well as external collaborations with customers and strategics. The position is responsible for optimizing formulation development while building robust and scalable manufacturing processes. She/he will also develop product and raw material specifications, design and execute laboratory and pilot scale experimental plans, analyze, and report data, and manage project timelines. She/he is responsible to transfer project goals from senior management and develop a thorough plan with punctual execution for the technical team culminating in clearly and well organized key reports. The ideal end-results can be achieved by pristine planning, proactive trouble shooting, improving efficiency, minimizing variation and reduction of the COGs.  This position is an exceptional opportunity to gain a complete picture of the product life-cycle with hands-on experience, cross-division interaction, and leadership development. Made for you who is eager to grow!

This workflow is expected to split approximately 65% of time in lab and 35% of time in communications and operations.

Salary starting at $90,000 for experienced candidates.

Responsibilities:

  • Self-starter with proven ability to effectively drive projects from concept to launch, execute tasks within defined programs timelines and work independently with limited oversight
  • Anticipate potential technical issues before they occur and establish action plan with supervisor and technical team
  • Drive programs to completion to meet timelines
  • Take responsibility as a team lead, and also serve as excellent teammate with others both internally and externally

Development component: (20%)

  • Design and perform multivariate studies of different formulations of a particular product, minimizing the number of replicates while maximizing the amount of information obtained
  • Develop and implement of high-throughput and automation approach that enhance formation development operations
  • Leverage a deep knowledge of cryobiology and the regenerative medicine field to modify excipients (inactive ingredients) to improve the formulation stability, biocompatibility and drive to successful final products
  • Perform labor of platform engineering design for existing projects, including troubleshooting, upgrades and capacity expansions, equipment management and upgrading.
  • Responsible for data interpretation, analysis and generating concise technical reports, peer review publications and white papers

CMC component: (65%)

  • Hands-on preparation of formulations for the projects targeting a variety of biosystems
  • Develop robust processes and well documented SOPs for scale-up production and formulation QC process
  • Design and adhere to quality control processes
  • Develop detailed COGs analysis of raw material sourcing and process compliance within regulatory needs
  • Facilitate setup, maintenance, and calibration of laboratory equipment needed for meeting compliance requirements
  • Prepare and characterize molecules using appropriate analytical tools including IR, NMR, MS, GC, and HPLC

Outreach component: (15%)

  • Serve as internal technical lead in pilot studies and other business meetings, industrial/academic conferences
  • Maintain current awareness of scientific literature and field trends
  • Prepare technical reports, and peer review publications (e.g. papers and presentations) and other white papers
  • Proactively review and assess the impact of regulatory guidance on current and future operations

Required experience and skills:

  • M.S. or Ph.D. in chemistry, chemical engineering, biochemistry, or related discipline
  • 5+ years of related industry experience
  • Proven development of processes within a CMC / cGMP environment
  • Exhibit excellent organization, planning and multi-tasking skills
  • Takes pride in completing tasks with diligence and detail
  • A proactive attitude for all tasks (process development, innovation, approach, communication) is required in a dynamic team environment
  • No task is too big or too small for you … “can do” attitude
  • Must have strong interpersonal skills to establish efficient work-flow and communications with internal departments as well as external customers
  • Proven excellent written/verbal and presentation skills, excellent publication records
  • Assess activities using a risk management approach
  • Ideal candidate must be self-driven, highly efficient, and output focused, put in occasional overtime and weekend hours as required
  • Able to physically lift 25-50lbs
  • Must be able to perform chemistry bench research without prohibitive limitations


Exceptional candidates:

  • Persistent individual who is eager to grow with the team to achieve the ultimate goal: Organs on Demand
  • Exceptional team lead as well as a supportive team player
  • Strong processing skills in organic synthesis, solid-phase synthesis, purification, and characterization
  • Experienced in automation and high-throughput synthesis or screening
  • Engineering skills are plus, such as programming, instrumentation, fluid dynamics, CAD, etc.
  • Experience in the Regenerative Medicine industry such as cell banking, cell & gene therapy, engineered tissue constructs, and organ transplantation
  • Deep knowledge and hands-on experience in cryopreservation

X-Therma is an Equal Opportunity Employer. X-Therma does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.