Scientist/Engineer, Process & Formulations
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.
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.
- 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
- 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.