Scientist/Process Engineer, Manufacturing Sciences
3 weeks ago
TScan Therapeutics is a clinical-stage biotech seeking to revolutionize life-changing therapeutics for patients by identifying novel T cells and epitopes. We are looking for an experienced Scientist or Process Engineer to join our Manufacturing Science team, supporting TScan's cell therapy manufacturing process development and GMP production of clinical cell therapy candidates. The ideal candidate should have relevant experience in cell therapy process development, technology transfer to GMP manufacturing and GMP principles related to cell therapy, and enjoy fast-paced, collaborative and vibrant startup culture. A team player with a sense of urgency will thrive in this role.
Role Overview and Responsibilities:
As a subject matter expert (SME), this position will be responsible for manufacturing science efforts supporting TScan's internal and external technology transfers and manufacturing process. This role helps develop and implement manufacturing process improvements, provide technical advice during manufacturing, support manufacturing investigations and risk assessment, and mitigate process risks. This position will collaborate closely with the process development, analytical development, supply chain, project management and manufacturing teams to ensure process implementation to commercial manufacturing following project timeline and TScan's goals.
The successful candidate will have experience in at-scale cell therapy process development, GMP cell therapy manufacturing, and be able to work highly independently in a fast-paced environment. Proven excellence in technical problem solving, project management, attention to detail, and communication is a must.
Responsibilities
- Collaborates with Process Development, Manufacturing, Analytical Development, Quality and Clinical operations to ensure successful completion of technology transfer and transfer of process improvements to TScan's internal and external manufacturing facility.
- Performs risk assessment and mitigation during product technology transfer and manufacturing.
- Performs hands on laboratory training with manufacturing staff and serves as the manufacturing process SME during technical transfer and GMP manufacturing.
- Develops and executes development studies in support of new equipment, products, and processes.
- Develops and reviews manufacturing process description, master production records and process performance qualification/process validation protocols.
- Utilizes manufacturing process knowledge and investigation skill sets to troubleshoot, identify and resolve manufacturing issues, improve process unit operations and affect positive change.
- Regularly provides progress reports, technical reports, and other status updates to the CMC and Technical Operations leadership teams.
- Practices and promotes safe work habits and adheres to TScan's safety procedures and guidelines.
- Advanced degree (BS, MS or PhD) in Chemical/Biochemical Engineering, Biochemistry, Immunology, or related degree with experience (8+ for BS, 5+ for MS, 2+ for PhD) in process development and manufacturing sciences in cell therapy, biotechnology, or pharmaceutical industry
- 3+ years Industry experience with process development, manufacturing process technical transfer, risk assessments, technical operations, and quality systems interfacing a GMP environment.
- Lab-based experience with aseptic processing, cell culture, cell therapy manufacturing and cell isolation.
- Working knowledge of GMP equipment, analytical testing, such as flow cytometry and cell counting analytics is preferred.
- Knowledge of Immunology or Immune-oncology, especially T cell biology is desired.
- Knowledge of GMP regulations and ICH/quality guidelines related to cell therapy manufacturing.
- Excellent communication and interpersonal skills.
- Highly organized with immense attention to detail.
- Demonstrated effective collaboration and communication with laboratory and manufacturing staff.
About TScan:
TScan Therapeutics was founded in 2018 by a small group of scientists led by Dr. Stephen Elledge (Harvard Medical School/HHMI). TScan is discovering and developing novel TCR-engineered T cell therapies for the treatment of cancer. TScan's discovery platform is centered around a breakthrough technology that enables the rapid, comprehensive, and genome-wide identification of the peptide antigen targets of T cell receptors. This technology greatly enhances our ability to understand the specific antigens that drive important disease processes, including tumor cell recognition by the immune system, self-reactivity in autoimmune disorders, and acquired immunity in infectious disease. TScan is using the platform in oncology to discover new TCR/target pairs and to rapidly move novel TCRs into clinical development.
Do YOU have the anatomy of a TScanner?
Our talented, compassionate, and intelligent team is what makes TScan a great place to work. Our brand-new offices with approximately 40,000 square feet of premium lab, manufacturing and office space is an environment that supports innovation, camaraderie and professionalism. We are driven, passionate, fun, flexible and team oriented. Sound like you? Apply today.
-
Scientist/Process Engineer, Manufacturing Sciences
2 months ago
Waltham, United States TScan Therapeutics Full timeJob DescriptionJob DescriptionPosition Summary:TScan Therapeutics is a clinical-stage biotech seeking to revolutionize life-changing therapeutics for patients by identifying novel T cells and epitopes. We are looking for an experienced Scientist or Process Engineer to join our Manufacturing Science team, supporting TScan’s cell therapy manufacturing...
-
Scientist, CMC Process Sciences
2 days ago
Waltham, United States Dyne Therapeutics Full timeCompany Overview: Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle...
-
Scientist, CMC Process Sciences
4 days ago
Waltham, Massachusetts, United States Dyne Therapeutics Full timeCompany Overview:Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue....
-
Waltham, United States Stratacuity Full timeLocation: Waltham, MA (Hybrid) Science: Antibody Drug Conjugates Therapeutic Area: Oncology Job Overview: This role will support commercial manufacturing, lead technology transfers, oversee CMOs, and ensure process validation activities are completed, while possessing strong communication skills and the ability to work collaboratively across various...
-
Waltham, United States Stratacuity Full timeLocation: Waltham, MA (Hybrid)Science: Antibody Drug ConjugatesTherapeutic Area: OncologyJob Overview: This role will support commercial manufacturing, lead technology transfers, oversee CMOs, and ensure process validation activities are completed, while possessing strong communication skills and the ability to work collaboratively across various...
-
Process Engineer
11 hours ago
Waltham, United States LASE Innovation Inc. Full timeWe are seeking a highly motivated individual with a successful track record to join LASE Innovation as a Process Engineer. LASE Innovation is a life science platform startup company that is ushering in a new era of ultrahigh dimensional single-cell analysis to solve complex biological problems and diseases by providing access to high-dimensional...
-
Process Engineer
1 day ago
Waltham, United States LASE Innovation Inc. Full timeWe are seeking a highly motivated individual with a successful track record to join LASE Innovation as a Process Engineer. LASE Innovation is a life science platform startup company that is ushering in a new era of ultrahigh dimensional single-cell analysis to solve complex biological problems and diseases by providing access to high-dimensional...
-
Waltham, United States Stratacuity: Proven Scientific Placement Full timeLocation: Waltham, MA (Hybrid)Science: Antibody Drug ConjugatesTherapeutic Area: OncologyJob Overview: This role will support commercial manufacturing, lead technology transfers, oversee CMOs, and ensure process validation activities are completed, while possessing strong communication skills and the ability to work collaboratively across various...
-
Senior Scientist, Bioinformatics
3 days ago
Waltham, United States CSL Behring Full timeWe have an exciting opportunity available for Senior Scientist, Bioinformatics & Data science, to join our Biopharmaceutical Product Development (BPD) department to shape the data analytics infrastructure, lead RNA-centric bioinformatics pipeline development and transform next-generation sequencing (NGS) data to therapeutics discovery.As the first...
-
Data Scientist
4 days ago
Waltham, United States Scipher Medicine Full timeAbout Us:Scipher Medicine is a precision immunology company that uses AI and network science to match patients with the most effective therapies. Its flagship product, PrismRA, is a blood-based test that predicts whether a patient with RA is likely to respond to anti-TNF therapy. Scipher Medicine is also developing the Spectra platform, which can be used to...
-
Data Scientist
4 days ago
Waltham, United States Scipher Medicine Full timeAbout Us:Scipher Medicine is a precision immunology company that uses AI and network science to match patients with the most effective therapies. Its flagship product, PrismRA, is a blood-based test that predicts whether a patient with RA is likely to respond to anti-TNF therapy. Scipher Medicine is also developing the Spectra platform, which can be used to...
-
Manufacturing Engineer II
5 days ago
Waltham, United States Evident Group Full timePress Tab to Move to Skip to Content Link Select how often (in days) to receive an alert: Select how often (in days) to receive an alert: Are you looking for a company that cares about people’s lives and health, including yours? At EVIDENT, we help make people’s lives healthier, safer and more fulfilling, every day. Job Description The successful...
-
Senior Manufacturing Engineer
3 weeks ago
Waltham, United States AVAVA, Inc Full timeJob DescriptionJob Description SUMMARY · The Senior Manufacturing Engineer’s primary focus will be to create and maintain internal and external manufacturing procedures, processes, and fixtures used in the manufacturing of medical devices. This position will also provide critical DFM and DFT feedback during the development process. All procedures and...
-
Senior Manufacturing Engineer
4 weeks ago
Waltham, United States AVAVA, Inc Full timeJob DescriptionJob Description SUMMARY · The Senior Manufacturing Engineer’s primary focus will be to create and maintain internal and external manufacturing procedures, processes, and fixtures used in the manufacturing of medical devices. This position will also provide critical DFM and DFT feedback during the development process. All procedures and...
-
Manufacturing Supervisor
3 days ago
Waltham, United States TScan Therapeutics Full timeJob DescriptionJob DescriptionPosition Summary:TScan Therapeutics is a clinical-stage biotech seeking to revolutionize life changing therapeutics for patients by identifying novel T cells and epitopes. We are looking for an experienced manufacturing professional to join our team as a Manufacturing Supervisor. The ideal candidate should have extensive...
-
Process Engineer I
4 days ago
Waltham, United States DPS Group Global Full timeSummaryA Process Engineer is responsible for ensuring operability and reliability of GMP manufacturing process equipment located at manufacturing facilities. This Candidate provides process engineering service support and coordinate various engineering activities with outside groups (e.g., Manufacturing, Facilities, Validation, Quality). This individual will...
-
Research Engineer
4 weeks ago
Waltham, United States A123 Systems Full timeA123 Systems, LLC is in search of a Research Enginee r for our Waltham, MA location. A123 Systems, LLC is a leading developer and manufacturer of lithium-ion batteries and battery systems for the transportation and commercial markets. Applicable to a wide range of industries, A123 Systems’ products remove many traditional technology constraints to provide...
-
Associate Scientist
2 months ago
Waltham, Massachusetts, United States Cambrex Full timeCompany Information You Matter to Cambrex. Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With more than 40 years of experience and a growing team of over 2,400 professionals servicing global clients, Cambrex is a...
-
Associate Research Scientist, Life Science
23 hours ago
Waltham, MA, United States AstraZeneca PLC Full timeAt AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We continuously forge partnerships that help pursue premier medicines in new ways, combining our people's exceptional skills with those of people from all over the globe. As a part of our Dynamic Omics team, you'll play a pivotal role in channelling our...
-
Manufacturing Technical Lead
2 days ago
Waltham, United States TScan Therapeutics Full timeJob DescriptionJob DescriptionPosition Summary:TScan Therapeutics is a clinical-stage biotech seeking to revolutionize life changing therapeutics for patients by identifying novel T cells and epitopes. We are looking for an experienced manufacturing professional to join our team as a Manufacturing Technical Lead.The ideal candidate should have extensive...
