Quality Engineer / Manager (Aseptic Fill)

Company: X-Therma Inc.
Location: Berkeley
Posted on: August 7, 2022

Job Description:

Quality Engineer/Manager (Aseptic Filling)
X-Therma, a venture backed medtech company pioneers ground-breaking cold chain technology via a convergent biopreservation platform, to advance Regenerative Medicine and make available safe and on-demand organs, engineered tissues, and cell & gene therapies to patients in need with a total addressable market of over $10B. X-Therma collaborates with renowned research institutions such as Lawrence Berkeley National Laboratory and Johns Hopkins University and is supported with significant funding from the US Department of Defense, National Science Foundation, California Institute of Regenerative Medicine, etc.
X-Therma has made a quantum leap in demonstrating significant extension of organ shelf-life from a few hours to a few days in collaboration with a World leading surgical team. This is a paradigm shift that could make worldwide organ sharing possible and eliminate organ discard. We are generating revenue in the Cell & Gene Therapy field and are currently experiencing exponential growth of commercial partnerships with the top CGT developers. Immediately, the technology could resolve current bottlenecks in Regenerative Medicine biomanufacturing and processing (TAM $8.8B) and allow "off-the-shelf" living medicines in this hyper-growth space.
Recently, our technology was designated as a Breakthrough Device by the FDA.
We appreciate talented, driven, and fearless teammates looking to make a positive impact for the World with robust commercialization experience. We are in the SF East Bay near Berkeley, not only known for its beautiful scenery and comfortable weather all year round, but also you can truly embrace the breath of innovations and dream building spirit of San Francisco's Biobay.
Check out the team you will work with:https://www.linkedin.com/feed/update/urn:li:activity:6863381188938203136/ -What's in it for you?You will have a great opportunity to contribute to ground breaking, life-saving products through the full product development cycle. This role is responsible for driving the day-to-day behind the quality operations of the Company. The applicant will have close interactions with the executive team and others at all levels. This role demands a highly goal-driven approach and the ability to focus on time-sensitive objectives within the most urgent priorities. Important for this role is the ability to proactively monitor, build, and adjust all aspects of quality and how quality relates to the performance of an organization. The individual in this role must be comfortable with cross-functional work between QA, labs, procurement teams, engineering, etc. A recognition that patients are waiting for organ transplant, tissues for repair, and advanced Cell & Gene therapies is essential to both the role and to the urgency of action required for success. -What you will do:While working directly with our Head of Quality, you will have experience and desire to

• Develop and implement documentation control function including preparation and distribution of operating procedures, batch production records, lot packages, maintenance of historical files and master records, and issuance of batch records and procedures manuals. -Develop, update, review and approve SOP's to conform to company and federal regulations.
• Recommends and develops a compliance strategy for management on GMP matters and regulatory compliance posture of the individual departments
• Reviews process, raw material, equipment changes and deviations to determine impact on product quality and acceptability. -Approves all changes and determines the quantity and types of testing required to assure acceptability of product thus meeting regulatory requirements and SB standards.
• Manages compliance activities including compilation of annual report information for all products and for the filing/finishing operations at X-Therma, updating DMF's, DEA activities and PDMA activities. -Coordinates efforts to assure all mandatory licenses and registrations are kept current and in compliance with Federal and State Requirements.
• Responsible for reviewing and approving all proposed technical changes via Change Control System, having potential impact on PLA's and ELA's to determine type of notification, if any, to FDA. -Responsible for obtaining approvals per corporate procedures for proposed changes impacting PLA and ELA, and preparing dossiers for submission.
• Coordinates, performs, evaluates and reports findings and follow-up activities of routine audits. -Provides each audited area with the support and guidance to undertake necessary corrective actions. -Maintains a follow-up system to assure that required improvements and programs are being carried out as planned.
• Develops and implements the training/education function including development and administration of training activities relating to cGMP's, departmental operating procedures and statistical process control programs, developing in-house programs, maintaining audio/visual inventories and maintaining training records.
• Interprets all applicable regulations and associated guidelines dealing with such matters for the company. -Keeps informed on trends and developments in the field of GMP regulations and on industry practices of compliance.
• Directs the daily Product Assurance functions; product inspection, record review and release to stock for finished product. -Examines and evaluates investigation reports and dispositions raw materials, intermediates and finished products. Reviews on-going records for completeness, accuracy and compliance; manages collection of reserve and laboratory samples of finished products.
• Determines the acceptability of materials where deviations have occurred. -After reviewing all technical aspects including Investigation Reports and GMP information determines what further information is needed for the disposition of the material to be determined. Routinely responsible for releasing materials.
• Develops objectives, educates personnel in compliance, develops, and implements GMP Audit Program for all operating areas -Qualification:This is a role best suited for:
  • Thrive in an early stage environment with a proactive attitude; no task is too big or too small for you
  • Industrial experience in quality organizations, either in operations or assurance functions.
  • Preferably 3+ years leading quality assurance (compliance and /or product release) within clinical or commercial organization
  • Fully versed in GMP's, FDA and other regulatory agency requirements for validation and operations, and compliance
  • Prior responsibility for technical SOPs, Batch Production Records (BPR) and technical reports
  • Strong process and detail orientation
  • Flexible mindset able to solve and anticipate problems
  • Proven strategic planning skills for management of long-term projects that lead to success
  • Ability to adapt and respond quickly to change in a dynamic, high-growth environment and radiate a positive impact to the team.
  • A strong work ethic to deliver results within timeline
  • Strong analytical and problem-solving skills, organization skills and attention to details
  • Must be able to work in an office setting without prohibitive limitations and internally audit laboratories -Position is eligible for option awards and benefits including medical, dental and vision insurance, 401(k) participation, vacation, and paid holidays. -On-site position. -Our package includes:--- Competitive base salary--- Health, vision, and dental benefits, with high family coverage--- 401(k) savings plan--- Employee Stock Option Plan--- Safe work environment for COVID response and high-quality PPEs.--- And more! -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.

Keywords: X-Therma Inc., Berkeley , Quality Engineer / Manager (Aseptic Fill), Executive , Berkeley, California