About CompanyNucleus RadioPharma is an end-to-end contract development and manufacturing organization (CDMO) partner dedicated to building robust and reliable clinical and commercial supply chains for targeted radiotherapies so that radiopharmaceutical companies and other innovators can succeed.Position SummaryThe Associate MSAT Engineer supports the technical transfer, scale-up, validation, and lifecycle management of radiopharmaceutical manufacturing processes within a cGMP-regulated environment. This role serves as a key technical partner between LABS/Process Development, Manufacturing, Quality, Engineering, and Customer Program teams to ensure robust, compliant, and efficient production processes. Responsibilities include technology transfer activities, process characterization, engineering and process validation runs, deviation investigations, change controls, and continuous improvement initiatives. The position offers an opportunity to contribute directly to the development and manufacture of life‑changing radiopharmaceutical therapies while building technical expertise in process science, manufacturing technology, and operational readiness.Principal ResponsibilitiesSupport cross‑functional collaboration with sponsors, R&D, Quality, Supply Chain, Engineering, and Safety teams to design and implement new equipment, processes, and technologies in support of GMP manufacturing.Support technology transfer activities for new and existing products, ensuring seamless transition from R&D into GMP manufacturing facilities.Author and review key technical and GMP documentation, including user requirement specifications, risk assessments, system classifications, validation protocols (IQ/OQ/PQ), SOPs, batch records, training materials, and logbooks.Provide technical expertise and troubleshooting for equipment, processes, and deviations throughout the product lifecycle.Deliver training programs to ensure staff competency in equipment operation, aseptic techniques, and process execution.Partner with Quality Assurance on investigations, deviations, CAPAs, and root cause analyses, ensuring regulatory compliance and timely resolution.Identify and optimize production efficiency and facility capability through process improvements, material workflows, and facility/room layout enhancements.Collaborate with Supply Chain and Engineering to ensure timely availability of consumables, spare parts, and equipment required to meet production and sponsor requirements.Provide SME support for regulatory inspections, audits, and sponsor interactions.Champion safety, compliance, and continuous improvement within MSAT and across manufacturing operations.Perform other related duties as assigned.Qualifications & RequirementsBachelor's degree in a STEM discipline (Chemistry, Engineering, Biology, or related field) required; advanced degree preferred.Minimum of 2 years' experience in an FDA-regulated cGMP environment (21 CFR Parts 210 and 211 required).Demonstrated expertise in aseptic processing, radiopharmaceutical development, pharmaceutical formulation and regulated production of therapeutics.Hands‑on experience with hot cell operations and industry‑standard automated synthesis, dispensing, and packaging systems preferred.Strong technical writing skills with a proven ability to author validation protocols, SOPs, and other cGMP documentation.Mechanical aptitude and strong problem‑solving skills with the ability to provide frontline troubleshooting of equipment and processes.Experience leading technology transfer projects and supporting manufacturing operations at a senior technical level.Excellent communication, interpersonal, and collaboration skills with the ability to influence and work effectively across functions and with external partners/sponsors.Strong organizational skills, attention to detail, and ability to manage multiple priorities in a fast‑paced environment.Proficiency with Microsoft Office Suite and related software.Ability to travel up to 25% as business needs require.Physical requirements: visual acuity sufficient to inspect product quality; manual dexterity for handling small items; ability to lift up to 50 lbs. and perform tasks requiring bending, kneeling, or crouching.Potential requirement to pass respiratory fit testing to meet safety requirements.Normal near visual acuity (20/20 with or without corrective lenses) and no impairment of color vision; testing for visual acuity and color discrimination required.The Fine PrintThe salary range for this position is $85,000 – $115,000. Compensation may vary outside this range depending on qualifications, skills, competencies, experience, and location.Benefit packages include medical, dental, and vision insurance, as well as a Health Savings Account or Flexible Spending Account options (depending on the plan chosen), and 401(k) retirement account access with employer matching. Team members are also entitled to paid sick leave and/or other paid time off in compliance with applicable law. Relocation is available to qualified team members.This job description is a summary of the typical functions of the position and is not an exhaustive or comprehensive list of all possible duties. The company reserves the right to assign or reassign duties and responsibilities to this job at any time. This job does not constitute a written or implied contract of employment; employment remains at-will.Nucleus RadioPharma is an equal‑opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.#J-18808-Ljbffr