Senior Technical Writer Jobs in Rochester, MN (NOW HIRING)

About Company:

Nucleus 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 SUMMARY:

The Associate MSAT Engineer is responsible for supporting 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.

They will support technology transfer activities, process characterization, engineering and process validation runs, deviation investigations, change controls, and continuous improvement initiatives. The role requires a strong understanding of aseptic processing, cGMP manufacturing, and radiopharmaceutical operations, along with the ability to work cross-functionally in a fast-paced clinical and commercial manufacturing environment.

This 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 RESPONSIBILITIES:

• Support 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.
• Support manufacturing operations throughout the product lifecycle, providing technical expertise and troubleshooting for equipment, processes, and deviations.
• Support and 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 & REQUIREMENTS:

• Bachelor’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.
• May be required 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 PRINT:

The salary range for this position is $85,000 – 115,000. Please note that compensation may vary outside of this range depending on several factors, including but not limited to a candidate’s qualifications, skills, competencies, experience, and location.

Benefit packages for this role include medical, dental, and vision insurance, as well as a Health Savings Account or Flexible Spending Account options (depending on the plan chosen), and 401k retirement account access with employer matching. Team members in this role 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, not necessarily an exhaustive or comprehensive list of all possible position responsibilities, tasks, and 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 and believes everyone deserves respect, dignity, and equality. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.