The University of Texas MD Anderson Cancer Center
Sr. Principal Scientist
The University of Texas MD Anderson Cancer Center, Boston, Massachusetts, United States, 02298
Job Title:
Sr. Principal Scientist
Job Number:
37086
Location:
Boston, MA
Job Description 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
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Sr. Principal Scientist
Job Number:
37086
Location:
Boston, MA
Job Description 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
#J-18808-Ljbffr