Quality Control Manager, TerraPower Isotopes

Title: Quality Control Manager TerraPower Isotopes

Location: Everett Washington

TerraPower Isotopes (TPI) has been established to pursue medical isotopes development--advancing nuclear science for significant human health benefits. We seek to support revolutionary radiotherapies for treatments of various cancers through the supply of radioisotopes. TPI currently produces actinium-225 for the growing alpha therapy market and intends to expand.

The TerraPower Isotopes (TPI) business is an integral part of the Washington State based TerraPower team a company working to raise living standards 2006 the company originated with Bill Gates and a group of like-minded visionaries who evaluated the fundamental challenges to raising living standards around the world. TerraPowers mission is to be a world leader in new nuclear technologies while developing innovators and future leaders in the nuclear field.

TPI is seeking to hire highly motivated and forward-thinking professionals who are interested in focusing on advanced radiopharmaceutical applications and influencing change within nuclear medicine. TerraPower is an Equal Opportunity Employer. We do not discriminate in hiring on the basis of sex gender identity sexual orientation race color religious creed national origin physical or mental disability protected veteran status or any other characteristic protected by federal state or local addition as a federal contractor TerraPower has instituted an Affirmative Action Plan (AAP) to proactively recruit hire and promote women minorities disabled persons and veterans.

Quality Control Manager TPI

TerraPower Isotopes (TPI) is seeking an experienced Quality Control Manager to support production of Ac-225 at the Everett manufacturing facility.

The Quality Control Manager will be responsible for oversight of the testing activities to enable production of Active Pharmaceutical Ingredient (API) starting material consistent with pharmaceutical industry requirements and play a critical role in the development and performance of analytical methods procedures and protocols that will be used for the characterization of actinium-225.

The Quality Control Manager will report to the Director Quality and work closely with a multidisciplinary team including site Quality Systems Operations Quality Control Engineering R&D Procurement and Project Management teams.

Responsibilities:

Manage analytical QC team in delivering Ac-225 batch-release ensuring robust application of validated radio-analytical methods including alpha spectroscopy gamma spectroscopy ICP radio-TLC and other relevant techniques.

Accountable for end-to-end QC execution data integrity documentation review and Certificate of Analysis (CoA) issuance enabling compliant batch disposition.

Manage development qualification and lifecycle management of analytical methods in compliance with ICH Q2 and cGMP expectations including procedure development and training.

Collaborate with TPI teams to coordinate installation calibration maintenance and troubleshooting of instruments and equipment that support TPI radioisotope production.

Ensure all work is performed in compliance with site safety and radiation protection guidelines.

Support the management of the chemical inventory including ordering evaluation for proper storage labeling and disposal of chemicals.

Support identification and implementation of approaches to improve instrument reporting data-flow infrastructure and data analysis methods withing a Laboratory In formation System Framework.

Lead and develop teams by fostering collaboration aligning priorities with organizational goals and creating a positive inclusive work environment that promotes growth and innovation.

Key Qualifications and Skills

A Bachelors level degree in chemistry with demonstrated post-graduate hands-on experience performing wet chemistry and radioanalytical measurement using techniques including gamma spectroscopy ICP-MS and ICP-OES and/or alpha-spectroscopy.

12 years of related experience with a Bachelors degree; or 8 years and a Masters degree; or a PhD with 5 years experience; or equivalent experience.

Experience working within a quality program compliant to FDA/cGMP requirements 21 CFR 210/211 and ICH Guidance; preferably experience in an operational radiopharmaceutical production facility.

Experience in developing and implementing new analytical methods and documentation relevant to radioisotope production.

Strong attention to detail with the ability to interpret federal regulations guidance and standards.

Proven ability to develop mentor and grow team members including setting clear expectations providing constructive feedback and supporting career development.

Excellent written and verbal communication skills including technical writing proficiency and reporting abilities to all levels of the organization.

Strong troubleshooting analytical and problem-solving skills such as those developed in fast-paced environments including the military and other nuclear or radiopharmaceutical environments is highly preferred.

The successful candidate will possess a high degree of trust and integrity communicate openly and display respect while fostering teamwork.

Job Functions

Job Functions are physical actions and/or working conditions associated with the position. These functions may also constitute essential functions for the job which the employee must be able to fulfill with or without accommodation. Information provided below is to help describe the job so that the applicant has a reasonable understanding of the job duties/expectations. An applicants ability to perform and/or tolerate these actions and conditions will be discussed and workplace accommodations may be made on a case-by-case basis following an individualized assessment of the applicant and other considerations including but not limited to any governing safety standards.

Motor Abilities: Sitting and standing for extended periods bending/stooping grasping/gripping fine motor control (hands) included extended operations with telemanipulators.

Physical exertion and/or requirements: Moderate with ability to safely lift up to 15 pounds.

Repetitive work: Prolonged.

Special Senses: Visual and audio focused work.

Work Conditions: Stairs typing/keyboard standard and/or sitting working environment of >8 hrs./day.

Position is based in Everett WA and work on-site in a radiochemical production laboratory is required.

Travel required 0-15%

TerraPowers technology is controlled for export by various agencies of the U.S. Government. TerraPower must evaluate applicants who are foreign nationals (other than asylees refugees or lawful permanent residents) in accordance with U.S. Government export control requirements. To facilitate TerraPowers export control reviews you will be asked as part of the application process to identify whether you are a U.S. Citizen or national asylee refugee or lawful permanent resident of the United States. Government export authorization approval times vary. Based on the business needs for a particular position TerraPower may not consider a foreign national from a country if it is impracticable to obtain timely Government export approval.

Job details

Salary Range L11: $138685 - $208027

Salary Range L12: $168316 - $252475
*Typically our employee salaries are within .90 1.0 of the mid-point of the posted salary bands. Any salary offered within the posted salary band is based on market data and commensurate with the selected candidates qualifications and experience. This range is specific to Washington State.

Benefits:

Competitive Compensation

Salary eligible to participate in discretionary short-term incentive payments

Comprehensive Medical and Wellness Benefits Medical

Vision

Dental

Life

Life and Disability

Gender Affirmation Benefits

Parental Leave

401k Plan

Generous Paid Time Off (PTO)

21 days of annually accrued PTO

Generous Holiday Schedule

10 paid holidays

Relocation Assistance

Professional and Educational Support Opportunities

Flexible Work Schedule

TerraPower Career and Benefits information: Experience:

Manager