Nuclear Manufacturing Systems Manager - Remote

Remote: 
Full Remote
Contract: 
Work from: 

Offer summary

Qualifications:

Bachelor's degree in chemistry, physics, nuclear medicine, engineering, or a related field, or equivalent experience., Familiarity with cGMP manufacturing environment and FDA regulations is required., Knowledge of molecular imaging techniques and experience with analytical equipment preferred., Strong communication, analytical, problem-solving, and project management skills are essential..

Key responsibilities:

  • Manage Nuclear Manufacturing Systems, including Document Control and Quality Management System software.
  • Support Document Control activities and participate in Change Management within the PET and Nuclear Manufacturing network.
  • Liaise with stakeholders and participate in new site assessments and product development meetings.
  • Oversee training for PET Systems and Nuclear manufacturing processes, ensuring employee development needs are met.

PharmaLogic Holdings Corp. logo
PharmaLogic Holdings Corp.
501 - 1000 Employees
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Job description


PharmaLogic is the fastest-growing SPECT & PET radiopharmaceutical solutions provider and contract development and manufacturing organization (CDMO) with radiopharmacies across North America. We are passionate about expanding the power of radiopharmaceutical technology to provide transformative diagnostic and therapeutic agents to patients from bench to bedside. 
 
PharmaLogic offers you an exceptional opportunity to join our dynamic team as a Nuclear Manufacturing Systems Manager.


If you have a passion for nuclear medicine and want to make a significant contribution to patient care while working in a stimulating and dynamic environment, then this opportunity is for you.
 


 Job Responsibilities and Duties:


Responsible for Nuclear Manufacturing Systems Management, including but not limited to, Document Control, Quality Management System software, PET and Nuclear Manufacturing electronic systems training. 

Support Document Control activities for the PET and Nuclear Manufacturing network. 


Participate in Change Management. 

Manage, in conjunction with Operations and Quality Management teams, Document Change Control, implementation, filing and rollout within the PET and Nuclear Manufacturing network. 

Liaise with PharmaLogic stakeholders in support of product Sponsor Document Control. 

Participate in new site assessment, setup, development, and buildout management in relation to PET Systems and Nuclear Manufacturing process support of new facilities. 

Oversee Quality Management System software, including but not limited to system improvements, new product implementation within the QMS, and software upgrades. 

Support PET Systems and Nuclear manufacturing process training. Work with facility managers to ensure employee development and training needs are met. 

Participate in product sponsor meetings and support new product development within PharmaLogic PET and Nuclear Manufacturing networks as needed. 

Perform other job-related duties as assigned. 

 

Job Requirements │ Skills │ Education:

  • Requires a bachelor's degree in chemistry, Physics, Nuclear Medicine, Engineering, or a related field, or equivalent experience. 
  • Familiarity with a cGMP manufacturing environment, FDA regulations, 21 CFR part 211/212 and 21 CFR part 11, Electronic Records required. 
  • Knowledge of molecular imaging techniques and pharmaceutical study design and execution is desired. 
  • Experience managing teams and supervisory experience preferred. 
  • Experience with analytical equipment and software, including HPLC, RTLC, PTS, GC and associated software preferred. 
  • Superior teamwork, multi-tasking and time/project management skills. 
  • Excellent communication, analytical, problem solving, presentation and computer skills (including proficiency in MS Office software). 
  • Ability to travel up to 25%. 

 

Physical and Intellectual Requirements:

Manual dexterity for manipulating small items; regularly lift at least 50 pounds throughout each shift and to be able to lift 75 pounds on occasion. Able to handle standing, walking and sitting for 4+ hours with limited rest intervals; good eye-hand coordination; fair eyesight (with or without correction lenses); normal hearing in at least one ear (hearing range of 20 Hz to 20 kHz); ability to analyze situations, set priorities and meet deadlines while maintaining attention to detail in a fast-paced and dynamic environment; effective organizational skills; a commitment to continuous learning; an ability to work well both independently and as part of a team.

Come join our winning team and begin a fulfilling career with us by applying today.  
   
PharmaLogic is an Equal Opportunity Employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other protected class.
 
Benefits Include:

 401(k) retirement benefit program
 Medical
 Dental care
 Disability insurance
 Employee assistance program
 Life insurance
 Paid time off
 Vision care



Required profile

Experience

Spoken language(s):
English
Check out the description to know which languages are mandatory.

Other Skills

  • Microsoft Office
  • Communication
  • Multitasking
  • Time Management
  • Teamwork
  • Organizational Skills
  • Analytical Thinking
  • Presentations
  • Problem Solving

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