Aktis Oncology
Radiopharmaceutical Manufacturing Associate - CMC
Aktis Oncology, Boston, Massachusetts, us, 02298
Radiopharmaceutical Manufacturing Associate - CMC
Join to apply for the
Radiopharmaceutical Manufacturing Associate - CMC
role at
Aktis Oncology Radiopharmaceutical Manufacturing Associate - CMC
Join to apply for the
Radiopharmaceutical Manufacturing Associate - CMC
role at
Aktis Oncology Get AI-powered advice on this job and more exclusive features. Aktis Oncology is a biotechnology company pioneering the discovery and development of a new class of targeted alpha radiopharmaceuticals to treat a broad range of solid tumor cancers. Founded and incubated by MPM Capital, the company has developed proprietary platforms to generate tumor-targeting agents with ideal properties for alpha radiotherapy. Designed for high tumor penetration and long residence time, Aktis Oncology's molecules will quickly clear other areas of the body, thereby maximizing tumor elimination while minimizing side effects of treatment. This approach would enable clinicians to visualize and verify target engagement prior to exposure to therapeutic radioisotopes. 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. RESPONSIBILITIES This role will drive several areas of strategic importance to Aktis: 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 SOPs and other GMP documentation Upkeep and maintenance of inventory in the GMP Facility Maintenance of the GMP facility including assisting with radioactive waste stream management Perform radiation and contamination surveys KNOWLEDGE, SKILLS, AND ABILITIES Experience with aseptic operations and environmental monitoring Experience with QC methodologies (HPLC, GC, MS, Gamma Spec, etc.) Experience 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 to 60lbs Expertise with GMP radiopharmaceutical manufacturing and quality control is preferred QUALIFICATIONS Minimum, undergraduate degree with 5+ years of experience in the pharma industry; preferred, M.Sc. with 3+ years of experience 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 Aktis Oncology is an Equal Opportunity Employer and does not discriminate on the basis of race, religion, color, sex, gender identity or expression, sexual orientation, age, disability, national origin, veteran status, or any other basis covered by appropriate law. Aktis Oncology is committed to promoting and maintaining a work environment in which all applicants, employees, and other individuals are treated with dignity and respect free from unlawful harassment, discrimination, or retaliation. Seniority level
Seniority level Associate Employment type
Employment type Full-time Job function
Job function Manufacturing Referrals increase your chances of interviewing at Aktis Oncology by 2x Get notified about new Manufacturing Associate jobs in
Boston, MA . Manufacturing Technician - Multiple Openings and Levels
Fill\/Pack Operator 1 (11:00 p.m. - 7:30 a.m.)- Walpole, MA, 02032
Manufacturing Laboratory Technician 1 - Walpole, MA, 02032
Fill\/Pack Operator 1 -Walpole, MA, 02032
Fill\/Pack Operator 1 - Walpole, MA, 02032
Fill\/Pack Operator 1 - Walpole, MA, 02032
Fill\/Pack Operator 1 - Walpole, MA, 02032
Fill\/Pack Operator 1 - Walpole, MA, 02032
Fill\/Pack Operator 1 - Walpole, MA, 02032
Packaging Operator (Must Have Clean room, GMP & SOP Exp)
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Join to apply for the
Radiopharmaceutical Manufacturing Associate - CMC
role at
Aktis Oncology Radiopharmaceutical Manufacturing Associate - CMC
Join to apply for the
Radiopharmaceutical Manufacturing Associate - CMC
role at
Aktis Oncology Get AI-powered advice on this job and more exclusive features. Aktis Oncology is a biotechnology company pioneering the discovery and development of a new class of targeted alpha radiopharmaceuticals to treat a broad range of solid tumor cancers. Founded and incubated by MPM Capital, the company has developed proprietary platforms to generate tumor-targeting agents with ideal properties for alpha radiotherapy. Designed for high tumor penetration and long residence time, Aktis Oncology's molecules will quickly clear other areas of the body, thereby maximizing tumor elimination while minimizing side effects of treatment. This approach would enable clinicians to visualize and verify target engagement prior to exposure to therapeutic radioisotopes. 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. RESPONSIBILITIES This role will drive several areas of strategic importance to Aktis: 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 SOPs and other GMP documentation Upkeep and maintenance of inventory in the GMP Facility Maintenance of the GMP facility including assisting with radioactive waste stream management Perform radiation and contamination surveys KNOWLEDGE, SKILLS, AND ABILITIES Experience with aseptic operations and environmental monitoring Experience with QC methodologies (HPLC, GC, MS, Gamma Spec, etc.) Experience 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 to 60lbs Expertise with GMP radiopharmaceutical manufacturing and quality control is preferred QUALIFICATIONS Minimum, undergraduate degree with 5+ years of experience in the pharma industry; preferred, M.Sc. with 3+ years of experience 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 Aktis Oncology is an Equal Opportunity Employer and does not discriminate on the basis of race, religion, color, sex, gender identity or expression, sexual orientation, age, disability, national origin, veteran status, or any other basis covered by appropriate law. Aktis Oncology is committed to promoting and maintaining a work environment in which all applicants, employees, and other individuals are treated with dignity and respect free from unlawful harassment, discrimination, or retaliation. Seniority level
Seniority level Associate Employment type
Employment type Full-time Job function
Job function Manufacturing Referrals increase your chances of interviewing at Aktis Oncology by 2x Get notified about new Manufacturing Associate jobs in
Boston, MA . Manufacturing Technician - Multiple Openings and Levels
Fill\/Pack Operator 1 (11:00 p.m. - 7:30 a.m.)- Walpole, MA, 02032
Manufacturing Laboratory Technician 1 - Walpole, MA, 02032
Fill\/Pack Operator 1 -Walpole, MA, 02032
Fill\/Pack Operator 1 - Walpole, MA, 02032
Fill\/Pack Operator 1 - Walpole, MA, 02032
Fill\/Pack Operator 1 - Walpole, MA, 02032
Fill\/Pack Operator 1 - Walpole, MA, 02032
Fill\/Pack Operator 1 - Walpole, MA, 02032
Packaging Operator (Must Have Clean room, GMP & SOP Exp)
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr