- Manage and execute clinical research activities for multiple trials.
- Assist in Analytical Technology Transfer activities to contractors and provide technical assistance and supervision during routine QC / Manufacturing activities.
- Assist in resolution of quality events (laboratory investigations, deviations, change controls, CAPAs, risk assessments, impact assessments, out-of-specification (OOS)).
- Assist in the development and elaboration of phase appropriate method validation protocols, used for release and characterization.
- Contribute to regulatory filings such as IND and BLA.
- Establish processes, manage, and coordinate extended characterization testing of clinical product lots at Affini-T.
- Serve as a liaison between Analytical Development and Process Development teams to coordinate and perform analytical testing in support of process and product characterization and understanding.
- Develop and maintain analytical tracking and trending tools and systems to monitor product quality (QC release, in process data and characterization) stability, and method performance.
- Bachelors +9, Masters +6, PhD +4 in Biochemistry, Biology, or related field experience in the biotechnology/pharmaceutical industry with increasing responsibility in analytical development or quality control, or equivalent combination of education and experience.
- Extensive hands-on experience spanning analytical development of biologics and cell therapies (e.g., flow cytometry, cell-based assays, PCR, HPLC, CE etc.).
- Track record of successful analytical technology transfers and GMP manufacturing of clinical trial material.
- Excellent working knowledge of GMP and GLP requirements.
- Must have a good understanding of Quality Systems and demonstrate proficiency in the application of QA principles, concepts, industry practices, and standards. Good conceptual, strategic, analytical, problem solving, and organizational skills.
- Autonomous, take-charge, proven team player with a strong results orientation, positive "can do" attitude, and a sense of urgency to get things done.
- High emotional intelligence, sound temperament and professional attitude.
- Excellent communication skills, both verbal and written, and the ability to interface effectively with all levels of the organization. Strong communication skills with outside contract organizations are required.
- Results and detail-oriented; self-motivated, ability to work with minimal supervision.
- Personal alignment with Affini-T's values, mission, and vision.
- Sit for extended periods of time (2 or more hours)
-
Senior Director, Head of Product Sciences
1 week ago
Affini-T Watertown, United StatesJob Description · Job DescriptionAbout Affini-T Therapeutics · Affini-T Therapeutics is a biotechnology company focused on targeting oncogenic driver mutations with a "best-in-class" TCR therapy platform. Our innovative method of discovering high affinity TCRs specific to oncogen ...
-
Apellis Waltham, United StatesJob Description · Job DescriptionPosition Summary: · As part of the MSAT team, the Senior Manager of Drug Product Manufacturing Science and Technology, will manage tech transfer and process validation at contract drug product manufacturing sites. The Senior Manager of Drug Produc ...
-
BioSpace Cambridge, United StatesJob Details · By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all inf ...
-
BioSpace Cambridge, United StatesJob Details · By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all inf ...
-
Scientist, Cmc Radiochemistry
1 week ago
Mariana Oncology Watertown, United States**Description**: · Mariana Oncology is focused on an extremely exciting field of oncology of precision radiopharmaceuticals to treat unmet need in solid tumors. We are at the vanguard in developing best-in-class alpha · - and beta-emitting radioligands that target cancer, while m ...
-
Gmp Manufacturing Technician
2 days ago
Mariana Oncology Watertown, United States**Reporting**: · Associate Director, Clinical Manufacturing · **Description**: · Mariana Oncology is focused on an extremely exciting field of oncology of precision radiopharmaceuticals to treat unmet need in solid tumors. We are at the vanguard in developing best in class alpha ...
-
Takeda Pharmaceutical Company Ltd Cambridge, United StatesBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I subm ...
-
Associate Director
1 week ago
Novo Nordisk Watertown, United States**About the Department** · Our Boston Research & Development hub, anchored in the greater Boston area, brings together the best minds in life science innovation. The teams located in facilities in Lexington, Watertown and Cambridge reflect the full R&D continuum, from early resea ...
-
Epredia Cambridge, United StatesSr. Product Manager- Life Sciences, Digital Pathology and AI page is loaded · Sr. Product Manager- Life Sciences, Digital Pathology and AI · Apply · locations · US-Field-Michigan · Detroit MI · Boston · Cambridge, MA · Kalamazoo MI · time type · Full time · posted on ...
-
Takeda Cambridge, United StatesBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that · the information I provide in my application will be processed in line with · Takeda's · Privacy Notice · and · Terms of Use . · I further attest that all ...
-
Takeda Cambridge, United StatesBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda'sPrivacy Noticeand Terms of Use. I further attest that all information I submit ...
-
Operations Manager
1 week ago
TruGreen Watertown, United StatesFounded in 1973, TruGreen is the nation's leading lawn care provider, providing lawn, tree and shrub and pest services focused on exceeding its customers needs. The company operates more than 290 locations across the United States and Canada, with more than 14,000 employees. TruG ...
-
Takeda Cambridge, United States Full timeBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda'sPrivacy Noticeand Terms of Use. I further attest that all information I submit ...
-
Market Development Manager
5 days ago
Thermo Fisher Scientific Waltham, United States**Market Development Manager **R *** · **A Day in the life** · We are looking for a result driven and innovative Global Market Development Manager to help build and implement marketing strategies and programs for a robust portfolio of single-use consumable solutions supporting a ...
-
Key Account Manager
3 days ago
Leica Microsystems Waltham, United StatesFor over 170 years, Leica Microsystems has helped shape the future by developing groundbreaking optical and digital solutions. As a global leader, we're driven by continuous improvement to excite our customers and to create the best work environment for our people. Customer focus ...
-
Market Development Manager
21 hours ago
Thermo Fisher Scientific Waltham, United StatesAs part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide ou ...
-
Associate Director, Laboratory Information
3 days ago
AstraZeneca Waltham, United States**Associate Director, Laboratory Information Management System (LIMS) Product Owner** · **Gaithersburg, MD or Waltham, MA** · Join our Translational Medicine and Cancer Biomarker Development (TM/CBD) teams within Early Oncology at AstraZeneca, where we strive to transform oncolog ...
-
Regional Market Development Manager
1 week ago
Thermo Fisher Scientific Waltham, United StatesWhen you are part of the team at Thermo Fisher Scientific, you will do meaningful work, that makes a positive impact on a global scale Join more than 100,000 colleagues who bring our Mission to life every single day to enable our customers to make the world healthier, cleaner, an ...
-
Manager, Strategy
3 days ago
Alloy Therapeutics Waltham, United States**The Company** · We are Alloy Therapeutics—a biotechnology ecosystem company empowering the global scientific community to make better medicines together. Through a community of partners, we democratize access to pre-competitive tools, technologies, services, and company creatio ...
-
Associate Director, Device Manufacturing
2 days ago
Viridian Therapeutics, Inc Waltham, United States: · Reporting to the Vice President, Device Development & Commercialization, the Associate Director, Device Manufacturing will lead technical oversight of process development for assembly, packaging, labelling and functional testing of medical device/drug combination products. Th ...
Senior Scientist, Product Sciences - Watertown, United States - Affini-T
1 day ago
Description
Job Description
Job DescriptionAbout Affini-T TherapeuticsAffini-T Therapeutics is an emerging biotechnology company focused on targeting oncogenic driver mutations with a "best-in-class" TCR therapy platform. Our innovative method of discovering high affinity TCRs specific to oncogenic driver mutations is used to develop therapies against malignant diseases. Through the application of gene editing and synthetic biology, we aim to enhance T-cell fitness to overcome the immunosuppressive tumor microenvironment, with the goal of inducing long-term responses in patients with solid tumors.Affini-T Therapeutics is announcing a Scientist II/Senior Scientist opportunity at our headquarters in Watertown, MA.
Position SummaryThe Scientist II/Senior Scientist will be a key member of the Product Sciences Group (Analytical Development) in CMC and will work in a matrix setting interacting with other functions in CMC, QA, Reg Affairs, R&D, Translational and Clinical team members.
The individual will be involved in technical oversight of analytical activities with internal and external partners (CDMOs, Analytical Contract Labs) and will assist in analytical technology transfers for Drug Product TCR candidates, including critical intermediates such as LVV and non-viral vectors and gene editing reagents. The Scientist II/Senior Scientist will assist in establishing specifications, product comparability studies and providing support in the preparation of regulatory submissions and health authority interactions. The individual will also be responsible for managing and coordinating analytical activities in support of manufacturing process development, IND enabling studies and clinical material characterization. The individual may be involved in laboratory activities to support this effort.
The ideal candidate will have experience working with Quality Assurance and must have a high level of independence to carry out their responsibilities with minimal supervision. This is a unique opportunity to shape the CMC team and roadmap to product licensure at a small and rapidly growing biotechnology company.
Essential Duties and ResponsibilitiesThe major tasks for this position are as follows:
Desired and Required QualificationsEducation and Experience:
Powered by JazzHR
FWAurPC3bI
