Exempt Gmp Manufacturing Jobs (NOW HIRING)

Job Title: Principal, Manufacturing, Science and Technology (MSAT) Engineer

Reports to: Director, MSAT

Classification: Full Time, Exempt

Work Location: – Onsite Rochester

POSITION SUMMARY:

The Principal MSAT Engineer is responsible for technical leadership and end-to-end accountability for transferring, commissioning, validating, and supporting lifecycle cGMP manufacturing of radiopharmaceuticals They will also play a critical role in bridging research and development with cGMP manufacturing operations to enable the successful introduction, transfer, and lifecycle support of theragnostic radiopharmaceutical products. This role provides technical leadership in technology transfer, equipment/process commissioning, operational readiness, and equipment/process training, while serving as a subject matter expert (SME) in support of manufacturing excellence and compliance. The role is a strong collaborator and partners across R&D, Operations, Quality, Supply Chain, Engineering, and External CMOs/CROs, and is accountable for the successful launch, transfer, and sustained operation of manufacturing processes and equipment

PRINCIPAL RESPONSIBILITIES:

• Lead 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.
• Drive technology transfer activities for new and existing products, ensuring seamless transition from R&D into GMP manufacturing facilities.
• Ensure on time delivery, reliability and up time for manufacturing and future MSAT lab activities
• 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.
• Develop and deliver training programs to ensure staff competency in equipment operation, aseptic techniques, and process execution.
• Define lifecycle maintenances programs for all manufacturing equipment.
• Provide specialized expertise on custom equipment as it relates to manufacturing agility and reliability.
• Ensure current and future customer needs and equipment requirements are designed and executed appropriately
• Partner with Quality Assurance on investigations, deviations, CAPAs, and root cause analyses, ensuring regulatory compliance and timely resolution.
• 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.
• Assist in the development of operational KPI’s and develop metrics to report progress
• Work across sites to understand/make recommendations on network SOP’s, programs and systems.
• 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, equivalent, (Chemistry, Engineering, Biology, or related field) required; advanced degree preferred.
• Minimum of 8years’ experience in an FDA-regulated CGMP environment (21 CFR Parts 210 and 211 preferred.
• Demonstrated expertise in aseptic processing, radiopharmaceutical development, formulation, and production.
• Hands-on experience with hot cell operations and industry-standard automated synthesis, dispensing, and packaging systems.
• Strong technical writing skills with a proven ability to author validation protocols, SOPs, and other GMP 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 50% 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.

THE FINE PRINT:

The salary range for this position is $120,000 - $180,000. 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.