57 Manufacturing jobs in Rochester

Job Description

• Overview

  The Manager, Manufacturing will play an essential role in leading manufacturing operations of theragnostic radiopharmaceuticals. This position will oversee production staff in addition to providing leadership to meet company goals and leading a company focused business.

• Description

  PRINCIPAL RESPONSIBILITIES:

  
  

  • Oversees production activities by ensuring products are produced, analyzed, and released according to FDA, cGMP, DHS radiation safety, and other applicable federal, state, and local regulations.

  • Manages and helps coordinate production schedules to meet customer orders and demand.

  • Hires, trains, develops, and manages the performance of production team members. This includes setting goals, performance reviews, and conflict resolution.

  • Assists in inventory management, facility maintenance, equipment maintenance, and calibrations among other tasks as needed.

  • Operates production equipment and chemistry modules of moderate complexity for novel production of radiopharmaceuticals.

  • Assists in root cause analysis of production and/or QC failures including out of specification and non-compliance investigations.

  • Works with other team members and principal investigators to develop novel radiopharmaceuticals for clinical production at the Rochester, MN Facility.

  • Collaborates cross-functionally with quality control, micro, procurement, radiation safety, etc. to ensure products are shipped right first time.

  • Designs and procures production equipment and consumables needed for current and future client processes.

  • Works cross-functionally with team members to develop process and equipment standard operating procedures, logbooks, training/qualifications, and validation documentation for production of radiopharmaceuticals.

  • Performs other job-related duties as assigned.

  
  

  QUALIFICATIONS & REQUIREMENTS:

  
  

  • Bachelor’s degree in STEM field and / or equivalent combination of education and experience /training required.

  • Familiarity with a GMP manufacturing environment and working with FDA cGMP regulations required.

  • 3-5 years of radiopharmaceutical production experience required.

  • Experience in aseptic processing and techniques required.

  • Experience in managing teams in a matrixed organization.

  • Superior teamwork, multi-tasking, and time/project management skills.

  • Demonstrated organizational and decision-making abilities to prioritize competing work assignments in order to meet deadlines and adherence to quality standards.

  • Technical aptitude required for evaluating and procuring equipment needed.

  • Excellent communication, analytical, problem solving, presentation and computer/pc skills including Microsoft Suite and related software.

  • Ability to work varying shifts, including nights and weekends as required.

  • Mechanical aptitude required; manual dexterity for manipulating small items; ability to lift up to 50 lbs. and to handle frequent crawling, stooping, crouching, and kneeling.

  • Minimal travel up to 10%.

  • Ability to work in a cleanroom and sterile environment, adhering to strict health and hygiene standards to ensure the safety and quality of drug products.

  • Must report any health conditions (e.g., rashes, active infections) that could impact product integrity or contamination risks.

  • Chronic health conditions that prevent long-term performance of essential job functions may require evaluation and could affect employment status.

  • Proper garbing and personal hygiene must be maintained at all times when in the cleanrooms.

  
  

  THE FINE PRINT:

  The salary range in Minnesota is $100,000-150,000 per year. 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.

  
  

  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.

Job Description

Work Location: Rochester, MN - Onsite

POSITION SUMMARY:

The Manufacturing Specialist will play an essential role in manufacturing and production operations of theragnostic radiopharmaceuticals. This individual will perform all manufacturing related tasks and support functions including, but not limited to, routine cleaning of rooms and equipment, reagent preparation, component assembly, formulation, dispensing, packaging, of radiopharmaceuticals and other duties as required. This will be done by following current good manufacturing practices (CGMP), established standard operating procedures (SOPs), safety requirements, and quality processes to meet sponsor requirements. The Manufacturing Specialist will operate as an independent contributor with decision making abilities, independent discretion and judgement while maintaining advanced knowledge of equipment and the manufacturing processes. The Manufacturing Specialist will be responsible for scheduling and coordinating production runs with team members as well as writing and conducting on the job trainings.

PRINCIPAL RESPONSIBILITIES:

• Leads and supports other team members in a fast-paced manufacturing environment and setting, to include backing manufacturing goals, standards, mindsets, and behaviors both on and off the manufacturing floor.

• Ensures strict adherence to quality, safety, regulatory guidance, and written procedures in the manufacturing of final drug products in accordance with CFR (CGMP) guidelines, FDA, OSHA, and MN DHS.

• Performs routine cleaning of the manufacturing areas, setting up manufacturing equipment, performing daily checks on various manufacturing equipment, and operating of equipment in accordance with CGMP, SOPs, and aseptic technique.

• Follows all written procedures, verbal instructions, and communicates effectively, both written and verbally.

• Performs documentation and calculations in accordance with SOPs and CGMP guidelines.

• Operates manufacturing equipment and/or performs manual chemistry of moderate complexity for various phases of radiopharmaceuticals.

• Works cross-functionally with other team members such as R&D, quality, and safety to develop and/or update SOPs for the manufacturing of radiopharmaceuticals.

• Participates and performs effectively in a team environment. Proactively interacts with cross-functional departments such as quality and safety to ensure the operational success of the manufacturing areas.

• Writes documentation and trainings as needed to ensure operational success.

• Assists in scheduling manufacturing activities and team member staffing to support a 24/7 manufacturing environment.

• Coordinates manufacturing schedules, inventory management, equipment maintenance, and training and development of other manufacturing technicians.

• Maintains inventory of materials and consumables.

• Demonstrates willingness to be flexible and adaptable to the needs of the department and business.

• Takes initiative to achieve personal and departmental goals with quantifiable business results.

• Ensures internal / external sponsor expectations are met or exceeded.

• Works with Quality Assurance on investigations, deviations, root cause analysis, out of specifications, and/or non-compliance investigations.

• Performs other job-related duties as assigned.

MINIMUM QUALIFICATIONS:

• Bachelor’s degree in a STEM field such as chemistry, engineering, or biology and/or an equivalent of relevant years of experience in the field required.

• Minimum 2 years of relevant experience working in an FDA CGMP regulated environment with 21 CFR Parts 210 and 211 required.

• Experience in aseptic processing and techniques required.

• Manufacturing experience in radiopharmaceuticals, pharmaceuticals, biologics, or cell/gene therapy is required.

• Experience working with hot cells and automated processing equipment strongly preferred.

• Strong mechanical aptitude and scientific background is required.

• Must be capable of providing front line troubleshooting of manufacturing equipment and process issues and can properly elevate concerns and issues to appropriate personnel.

• Ability to support 24-hour manufacturing and may require nights, weekends, and/or the ability to work overtime when necessary.

• Superior teamwork, multi-tasking, and time management skills.

• Excellent communications, interpersonal and collaboration skills, and ability to interact professionally with a wide range of individuals and organizations, internal and external.

• Ability to work independently with minimal direction, and drive deliverables through to completion by deadlines provided.

• Highly organized with strong attention to detail and commitment to high quality work.

• Ability to work in a collaborative manner; identify challenges and barriers and recommend resolutions.

• Excellent communication, analytical, problem solving, presentation and computer/pc skills including Microsoft Suite and related software.

• Mechanical aptitude required; manual dexterity for manipulating small items; ability to lift to 50 lbs. and to handle frequent crawling, stooping, crouching, and kneeling.

• Must be able to visually discern, distinguish, inspect, assess, and observe quality of product daily.

• May be subject to respiratory fit tests to ensure job and environmental safety.

• Ability to work in a cleanroom and sterile compounding environment, adhering to strict health and hygiene standards to ensure the safety and quality of drug products.

• Must report any health conditions (e.g., rashes, active infections) that could impact product integrity or contamination risks.

• Chronic health conditions that prevent long-term performance of essential job functions may require evaluation and could affect employment status.

• Proper garbing and personal hygiene must be maintained at all times when in the cleanroom or compounding areas.

THE FINE PRINT:

The salary range in Minnesota is $75,000 to $90,000 per year. 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.

Description: Position Summary: The Senior Manufacturing Engineer will be responsible for contributing to the design of production machinery and will identify and recommend solutions to production problems related to materials, processes, and tooling. They will troubleshoot and diagnose assembly processes and reduce total defects through the analysis of data and corrective actions. This position will also support the functions of the WG Engineering Department to meet the requirements of the relevant ISO 9001:2015 standards based on the quality objectives established by Top Management. Essential Duties and Responsibilities: * Design and/or enhance manufacturing processes to assemble a bill of materials into a final product. * Utilize methods for waste minimization within a manufacturing system and address productivity. * Lead process improvements and controls through use of analysis and inspection/validation techniques * Document Corrective Actions and Preventative Actions. * Generate, validate, and update as needed assembly work instructions in a clear and presentable configuration. * Provides manufacturing decision-making information by calculating production, labor, and material costs; reviewing production schedules; estimating future requirements. * Support both assembly floor priorities and longer-term development project activities. * Meet required ISO 9001:2015 standards and necessary training based on the relevant Quality Objectives. Competencies: To perform this job successfully, an individual should demonstrate the following competencies: * Written Communication - Read and interpret written information effectively, write clearly and concisely, adapt writing style for different audiences. * Verbal Communication - Give focused attention to what others are saying, take time to understand what and respond when appropriate without interrupting, speak clearly and effectively express ideas and opinions, adapt and react professionally in both positive and negative situations. * Teamwork & Collaboration - Balance team and individual responsibilities, consider others' views objectively and with openness to changing your own, give and encourage feedback, contribute to a positive team dynamic, prioritize team success over personal interests, work effectively across departments toward company goals. * Professionalism - Interact with others in a considerate manner, follow through on commitments, react well under pressure and preserve confidentiality, control emotions, and accept responsibility, maintain focus on solutions and treat others with respect and consideration regardless of their status or position. * Motivation & Initiative - Demonstrate persistence and ability to adapt to changes in daily workflow and overcome obstacles, ask for and offer help when needed, work independently when required, volunteer readily and look for ways to improve and create successful outcomes, positively contribute to overall work environment. * Respect & Integrity - Treat people with respect, work ethically and with honesty and integrity, inspire the trust of others, demonstrate appreciation and sensitivity for cultural differences, help promote inclusion and understanding of the value of diversity, embrace differences and support a harassment-free environment. Requirements: Minimal Qualifications: * Minimum bachelor's degree (BA/BS) in mechanical, electrical, manufacturing engineering, or equivalent. * Knowledge of standard manufacturing techniques such as fastening, structural adhesive bonding, hand assembly/low volume operations and tools and functional product testing. * Experience with precision alignments and tolerance analysis. * Use of techniques such as additive manufacturing/3D printing to create assembly floor aids and holding fixtures. * Experience with methods for process improvement and control. * Knowledge of incoming inspection and validation techniques, such as optical inspection and CMM. * Basic knowledge of the requirements of an ERP system for product specifications and bills of materials and routings. * Strong organizational and time management skills with the ability to successfully manage multiple tasks in a fast-moving environment. Preferred Qualifications: * Experience in additional disciplines such as electrical/electronic, computer/data acquisition, optics. * 5+ years of experience in new product introduction and sustaining engineering. * Working knowledge of SolidWorks and PDM. * Experience in utilizing automation such as robotic assistance and metered dispensing systems, PLC, and Vision Systems as utilized for aiding productivity in manufacturing. * Knowledge of Six Sigma analysis for process improvement and control. * Experience providing input on existing and forthcoming designs as related but not limited to DFMA. Supervisory Responsibilities: None. Travel: Negligible. Physical Demands: Frequently required to sit, speak, hear, see, and perform repetitive motion (data entry). Occasionally required to lift or carry (10 lb. minimum). Reasonable accommodations will be made available if applicable. PI2f58c255bd0d-