Sr. Principal Scientist

Sr. Principal Scientist

Join to apply for the Sr. Principal Scientist  Recruiting.

Salary Range: $ – $ annually.

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

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.

Seniority Level

Mid‑Senior level

Employment Type

Full‑time

Job Function

Science

Location

Boston, MA

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