Sr. Principal Scientist

Sr. Principal Scientist

Join to apply for the Sr. Principal Scientist role  Recruiting.

Salary Range: $ – $ annually.

This role will report to the Director of Clinical Trial Manufacturing.

• 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.

• 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.

Mid‑Senior level

Full‑time

Science

Boston, MA