Sr. Principal Scientist

The role will be responsible for all operations involved with routine manufacturing and quality control testing of radiopharmaceuticals produced in Aktis’ GMP laboratory (Boston, MA), including but not limited to the list below.

This role will report to the Director of Clinical Trial Manufacturing

Salary Range:$136,800.00 To $189,200.00 Annually

Responsibilities

• Manual and automated production of radiopharmaceuticals in a GMP facility
• QC testing of radiopharmaceuticals
• Execution and upkeep of the facilities’ environmental monitoring program
• Accurate and timely preparation and completion of manufacturing and Quality control records (Batch Records, Forms, Logbooks, etc.)
• Process/analytical method validation for clinical manufacturing
• Operation and maintenance of equipment in the GMP facility
• Preparation of products for shipment to other sites
• Drafting, reviewing and updating GMP documentation including SOPs
• Upkeep and maintenance of inventory in the GMP Facility
• Maintenance of the GMP facility including assisting with radioactive waste stream management
• Perform contamination wipe tests and surveys
• Performing and maintenance of the facilities’ environmental monitoring program
• Leading manufacturing process and analytical method qualification activities
• Contribute to writing CMC sections for submission to regulatory agencies
• Maintain KPI and internal reports
• Supporting external tech transfer activities
  
  

Required Skills

• Proficient with aseptic operations and environmental monitoring
• Proficient with QC methodologies (HPLC, GC, MS, Gamma Spec, etc.)
• Proficient with assembly and interpretation of analytical data
• Expertise with troubleshooting analytical and production equipment
• High attention to detail and organizational skills to enable working in a fast-paced environment
• Ability to work in an ISO7 environment with full gowning
• Adhere to stringent cleanroom protocols and maintain a high level of hygiene
• Perform precise aseptic manipulations in a restrictive environment
• Awareness of FDA and EU GMP requirements
• Ability to lift 60lbs
• Expertise with GMP radiopharmaceutical manufacturing and quality control
• Minimum, B.Sc. with 10 years or M.Sc. with 7 years of experience in the pharma industry or equivalent research experience
• Comprehensive knowledge of GMP manufacturing and quality control workflows
• Excellent verbal, written, and organizational skills
• Strong desire to be part of a mission‐oriented company leading transformative change for patients
• Proven demonstration of transparent communication and fostering open and diverse debate
• Ability to work with agility and manage ambiguity
• Personifies positive energy and exemplifies respect