We are TAE Life Sciences

Position Summary: This role serves as head of the Regulatory and Quality functions and as Management Representative,
responsible for planning and leading the establishment, implementation, maintenance and continual improvement
of the quality management system in compliance with ISO 13485:2016 as well as FDA 21 CFR Part 820, ISO
14971, and EU Medical Device Regulation. The Director, RA/QA leads the teams performing all Quality functions
including Design Quality, Risk Management, Quality Engineering, Quality Operations, Quality Systems and
Quality Control. This role is also responsible for coordinating with consultants to establish and implement the
regulatory strategy for product commercialization in the EU, UK, and US.

Job Requirements:

• Bachelor's degree (BS) in technical or life science field.
• Demonstrated leadership and talent management (hourly and salaried)
• Training, certification and experience interpreting and implementing global regulatory requirements including
  ISO 13485, ISO 14971, 21 CFR Part 820, 21 CFR Part 11, EU MDR, MDSAP
• Excellent writing, speaking and presentation skills including authoring and editing procedures, plans, reports,
  investigations, protocols, and other quality system documents
• Excellent analytical and problem-solving skills, demonstrating sound judgment and understanding of strategic
  context
• Experience leading cross-functional teams to successful outcomes in support of business priorities
• Expertise in MS Office Suite
• Results-oriented, positive “can-do” attitude with demonstration of appropriate urgency and initiative

About the company: TAE Life Sciences is a technology and precision medicine company based in Foothill Ranch and Santa Monica, California. Our mission is to transform the clinical management and treatment of cancer via innovative and tissue sparing neutron radiation therapy known as BNCT. We re-engineer therapeutic antibodies against biologically important targets and enable them with the ability to deliver boron to tumor followed by neutron radiation to eradicate cancer cells by an in situ alpha-particle generation nuclear fission reaction, while sparing the non-cancer i.e. normal cells. Our first neutron beam medical device, Alpha Beam™, is due to be commissioned in Xiamen, China at the end of 2022.

Job Location: California, USA

Essential Duties and Responsibilities:

• Lead the organization to certify the medical device quality management system (QMS) against ISO 13485:2016, implementing and continually improving the QMS to maintain certification status.
• Lead implementation, maintenance and continual improvement of the Arena PLM software application for parts, assemblies, BOMs, documents, records, training, and other quality system elements.
• Lead, mentor, and coach a team of quality professionals performing the company’s quality activities
  including Document Control, Configuration Management, Change Control, Training, Supplier Quality, Software Quality, Validation, Quality Control Inspection, Design Control, Risk Management, Audits, Quality
  Planning, CAPA, Complaints, and Nonconformances.
• Disposition all quality records either directly or through delegation.
• Interface with all levels of the organization and all functions including electrical engineers, mechanical engineers and physicists developing experimental and commercial medical devices and components.
• Develop and promote awareness and understanding of the requirements for a medical device quality system through training and education.
• Serve as leader and coordinator for all external audits and inspections.
• Coordinate with consultants as needed to establish and implement a successful regulatory strategy.

Position Summary: The Quality Engineer (Validation) is responsible for supporting Engineering/Manufacturing activities by ensuring all processes and activities associated with product realization are completed in accordance with the Quality Management System and applicable international standards. The primary function of this role is to create validation procedures for ensuring that both manufacturing processes and products meet applicable standards and specifications. The Quality Engineer (Validation) is also the primary backup for
all Receiving Inspection duties when the primary inspector is out of the office or needs assistance with the workload. The role also supports Quality System activities associated with establishing and implementing an ISO 13485-compliant quality management system, including performing data entry.

Job Requirements:

• Bachelor's degree (BS) in technical or life science field or equivalent applicable medical device experience.
• Experience (3-5 years minimum) in a medical device or pharma/biotech quality system (i.e., ISO 13485, 21 CFR Part 820)
• Strong writing skills related to authoring and editing procedures, plans, reports, investigations, protocols, and other quality system documents.
• Strong analytical and problem-solving skills, demonstrating sound judgment, and understanding of strategic context.
• Experience participating within cross-functional teams to successful outcomes in support of business priorities is preferred.
• Experience using MS Office Suite.
• Results-oriented, positive “can-do” attitude with demonstration of appropriate urgency and initiative.

About the company: TAE Life Sciences is a technology and precision medicine company based in Foothill Ranch and Santa Monica, California. Our mission is to transform the clinical management and treatment of cancer via innovative and tissue sparing neutron radiation therapy known as BNCT. We re-engineer therapeutic antibodies against biologically important targets and enable them with the ability to deliver boron to tumor followed by neutron radiation to eradicate cancer cells by an in situ alpha-particle generation nuclear fission reaction, while sparing the non-cancer i.e. normal cells. Our first neutron beam medical device, Alpha Beam™, is due to be commissioned in Xiamen, China at the end of 2022.

Job Location: California, USA

Essential Duties and Responsibilities:

• Subject matter expert in Installation, Operational, and Performance Qualifications (IQ/OQ/PQ). Works with Engineering and Manufacturing to understand all components created in-house and all manufacturing processes which will be completed in-house. Develops necessary test procedures and executes the qualifications when necessary.
• Supports development of Quality Inspection Plans in alignment with Manufacturing Procedures and validated Critical to Quality Attributes.
• Works collaboratively with Procurement, Engineering, Manufacturing Engineering, Receiving, and other departments to ensure timely and high-quality execution of Receiving Inspection responsibilities when assisting or filling in for the primary inspector.
• Reviews supplier-provided documentation to determine compliance with Item Master requirements (in the PLM) including specifications and drawings. Maintains accurate and complete records for each item.
• Maintains the Receiving Inspection (RI) log, completing, scanning and filing completed RI quality records and regulatory compliance documents.
• Works collaboratively with Engineering to develop processes and supporting infrastructure (e.g., tools, procedures) to inspect incoming materials; perform accurate mechanical, physical, and visual inspection of parts; perform first article inspections; and inspect and measure items for dimensional accuracy, fit, alignment, and functional operation.
• Labels all inspected materials, accordingly, following visual inspection and final disposition.
• Initiates Nonconformance Reports as required, segregating and identifying nonconforming materials.
• Owns the Process Validation program.
• Owns the Control of Production, Monitoring, and Measuring Equipment program.
• Owns the Statistical Techniques program.
• Complies with written requirements, recommending improvements and enhancements to processes, and performing other duties assigned by leadership.

Position Summary: We are seeking a highly motivated chemist with solid grounding in organic chemistry and an interest in medicinal chemistry. The successful candidate will join our Chemistry Group to work on projects in the pursuit of novel bioconjugates and small molecules utilized in boron neutron capture therapy for curing diseases including cancer.

• An individual with a strong background in synthetic organic/medicinal chemistry. The successful candidate will be responsible for developing synthetic routes and chemical processes for small molecule prodrugs, and polymers for conjugation to biomolecules.
• The tasks include
  • Performing research in the laboratory as synthetic and medicinal chemist
  • Design and execute synthesis of organic molecules and biopolymers
  • Critically evaluate relevant scientific advances and integrate this knowledge into research programs
  • Instrumental in the intellectual property generation and patent filing
• This role works in a collaborative environment with cell biology / antibody generation & pharmacology group
• Experience in either bioconjugation chemistry or boron chemistry is a plus

About the company: TAE Life Sciences is a technology and precision medicine company based in Foothill Ranch and Santa Monica, California. Our mission is to transform the clinical management and treatment of cancer via innovative and tissue sparing neutron radiation therapy known as BNCT. We re-engineer therapeutic antibodies against biologically important targets and enable them with the ability to deliver boron to tumor followed by neutron radiation to eradicate cancer cells by an in situ alpha-particle generation nuclear fission reaction, while sparing the non-cancer i.e. normal cells. Our first neutron beam medical device, Alpha Beam™, is due to be commissioned in Xiamen, China at the end of 2022.

Job Location: California, USA

Essential Duties and Responsibilities:

• Work effectively with multidisciplinary team
• Help maintain lab in a clean and orderly way
• Articulate issues and options for resolution to upper management in a timely manner
• Write reports on work and accomplishments
• Present work at lab meetings
• Present summary data to multi-disciplinary team
• Lead molecules design and implementation and optimization using SAR and medicinal chemistry approaches
• Optimize multiple parameters during lead generation effort based on strong knowledge of medicinal chemistry and understanding of key ADME, biochemical and pharmacological
  principles
• Provide oversight for the transfer of chemical processes to third party CRO or CMO and
  develop novel and creative solutions to processing problems
• Publish research in peer-reviewed journals

Required Qualifications:

• Doctoral level degree in synthetic organic or medicinal chemistry.
• Additional post-doctoral experience or Industrial experience in developing synthetic routes and chemical processes for active pharmaceutical ingredients is preferred
• Highly proficient in advanced synthetic, purification and spectroscopic techniques utilized in the preparation and characterization of organic molecules
• Inorganic boron chemistry experience, drug-linker experience for ADC/ liposome chemistry knowledge are a plus
• Strong track record of achievement in synthesis of complex molecules with state of the art knowledge of modern synthetic methodologies and analytical and purification
  techniques
• Expertise in methodology development and successfully completed multistep syntheses
• Excellent written and oral communication skills; enthusiasm, integrity, self-motivation,
  and ability to interact within a multi-disciplinary team
• Proficient in business and lab software
• Strong adherence to laboratory safety practices

Position Summary: We are seeking a highly motivated and committed individual to apply scientific principles to all aspects of developing antibody and antibody fragment conjugates. The successful candidate will have experience in bioconjugation of proteins with a variety of moieties including boron enriched linkers, polymers and fluorophores. The individual should be adapt at performing purification techniques including ultrafiltration, UF/DF and chromatography and a variety of analytical methods used for characterization including HPLC, SDS-PAGE, fluorescence and other appropriate analytical techniques. As a member of the Chemistry team, the candidate will support bioconjugation process development efforts by performing routine laboratory experiments, meticulously documenting the data, presenting his work to the rest of the team.
Prior experience with ADC and antibody conjugation, chromatography and statistical analysis DOE approach is a plus. The candidate will interact with in-house research group and foster the development of new technologies. The ideal scientist will be drive innovation, solve technical problems, and work well as a member of a team.

About the company: TAE Life Sciences is a technology and precision medicine company based in Foothill Ranch and Santa Monica, California. Our mission is to transform the clinical management and treatment of cancer via innovative and tissue sparing neutron radiation therapy known as BNCT. We re-engineer therapeutic antibodies against biologically important targets and enable them with the ability to deliver boron to tumor followed by neutron radiation to eradicate cancer cells by an in situ alpha-particle generation nuclear fission reaction, while sparing the non-cancer i.e. normal cells. Our first neutron beam medical device, Alpha Beam™, is due to be commissioned in Xiamen, China at the end of 2022.

Job Location: California, USA

Essential Duties and Responsibilities:

• Conjugation of monoclonal antibodies with polymers, peptides and boron-enriched linkers at the early research stage
• Characterize the respective antibody product and conjugated products using analytic assays that include reverse phase HPLC, SEC HPLC, electrophoresis and ICP OES.
• Assist in the development of scalable, robust, efficient, and innovative chemical and biochemical conjugation processes suitable for clinical material production and subsequent commercialization
• Interact with CROs regarding analytical characterization when necessary
• Responsible for writing protocols and reports describing conjugation processes and analytic assays, as well as contributing to regulatory filings
• Communicate results in a timely manner and collaborate with internal and external development teams.

Required Qualifications:

• BS or MS degree in Biochemistry, Chemical Engineering, Chemistry, or a related fields with at least 3 years of industry experience
• 2 years of experience of handling, purifying and analyzing proteins, antibodies
• Experience with antibody conjugation and ADC is a plus
• Writing of CMC study reports and SOPs
• Must be highly motivated with excellent organizational and communication skills
• Must be able to work independently and as part of a multi-disciplinary team, with the ability to work in a dynamic, fast paced environment