11 jobs found in somerville

Your experience includes…     PhD or MS in relevant field with 10+ years of experience in the biopharmaceutical industry .   Expertise in o ligonucleotide synthesis , scal e -up, and purification process .   Leveraging in-process analytical characterization methods , CPP, CQAs etc . to assure robust scalable manufacturing control.   Managing external development or technology transfer of synthesis and purification methods.   Tracking record of manufacturing per GMP requirements, including the engagement of CRO and C D MO capabilities.   Authoring of relevant CMC s ections of IND, NDA/ BLA and other regulatory filings related to oligo nucleotide therapeutics . P articipating in health authority interactions   Driving novel oligonucleotide chemistry and processes to improve research candidate s.   Strong organizational leadership skills with a proven track...

This is a six month contract opportunity with potential for extension or conversion to FTE. Your experience includes…   BS in Biology or Life Science Discipline with a minimum of 0-2 years of industry experience History of working independently and managing projects in a fast-paced environment Strong attention to detail, a good problem solver, and results oriented Good verbal and written communication skills You are interested in…   Executing clinical GMP manufacturing operations in a fast-paced environment Learning and using single use systems and technologies Use of cGMPs and good documentation practices Authoring Standard Operating Procedures (SOPs), Work Instructions, Master Batch Records, and other supporting batch documentation About you:   You are a skilled individual who can execute on-the-floor manufacturing activities while ensuring the quality of the product and adhering to GMP procedures. As a member of the manufacturing team, you...

Your experience includes… PhD with 5+ years of relevant industry experience.  Excellent knowledge and thorough understanding of SPS and purification of Oligo’s  Leading design of oligos based on structure guided approach In-depth knowledge of oligo modification strategy Expert in operating instruments and equipment including HPLC, LC-MS, UV/Vis, MerMade, Dr. Oligo, AKTA Oligo Pilot Synthesizers Data analysis and decision making to make recommendations/presentations to senior leadership Prior experience leading direct reports – people/team management experience Ability to work efficiently within a dynamic team and/or independently under aggressive timeliness are required You are interested in… Driving innovation in oligo synthesis including design, synthesis and characterization of novel oligonucleotide structures to improve potency and efficacy.   Cross functional collaboration with research, translational biology, CMC and other groups Managing...

Your experience includes…     Ph.D. with 5+ years of relevant industry experience or M.S. with 10+ years relevant industry experience in Biochemistry, Molecular and Cell Biology or a related field.   Must have extensive molecular cloning (both design and wet lab) experience with a variety of different approaches (Golden Gate, Gibson, restriction enzyme digestion/ligation, Gateway, etc.).   Excellent organizational and documentation skills towards multitasking in an extremely fast-paced environment with changing priorities.   Team player with excellent oral and written communication skills   Independently motivated, detail-oriented scientist with excellent critical thinking and problem-solving abilities.   Experience with IVT RNA is a plus   People management experience is a plus   Experience with Sanger sequence analysis   Experience with NGS analysis preferred   Experience with automation preferred   Experience with...

Your experience includes… •    PhD. in Synthetic Biology, Cell Biology, Genetics, Molecular Biology, Biochemistry, Systems Biology, Immunology, or related field with 12+ years of industry experience in preclinical candidate development focused on genetic disease. •    Direct industry experience in genetic medicines, gene therapy or gene editing technologies. •    Team leadership experience with a demonstrated track record of personnel development including multiple PhD level scientists. •    It’s a bonus if you have mRNA, or siRNA/ASO experience or have worked with non-viral delivery methods (eg lipid nanoparticles). You are interested in… •    Working closely with the platform team to engineer Gene Rewriting therapeutic candidates. •    Leading preclinical therapeutic development programs through large animal studies. •    Overseeing disease model and analytical assay development. •    Contributing to IND/CTA applications and other regulatory findings. About you:...

Your experience includes…     PhD in synthetic organic chemistry or process chemistry, and 12+ years of relevant experience.   Deep understanding of modern methods in synthetic chemistry with an emphasis on nucleosides, nucleotides and oligonucleotide synthesis, and purification and analytical characterization as applied to nucleic acid therapeutics.   Oligonucleotide manufacturing including CRO and CMO capabilities, familiarity with GMP requirements.   Contributions to IND, BLA and regulatory filings   Strong organizational leadership skills with a proven track record in setting vision/strategy and managing team execution to achieve key company milestones.   Lead efforts to identify emerging trends in the oligonucleotide therapeutics field and maintain awareness of the competitive landscape.   Prior experience with long oligos via chemical synthesis or ligation is desirable .   You are interested in…   Developing...

Your experience includes…   BA/BS in scientific discipline and 12+ years of demonstrated GMP Quality experience in the pharmaceutical / biopharmaceutical industry; or MS degree and 10+ years of relevant experience Experienced with QA oversight of GMP manufacturing and Quality Control testing You are interested in…   Executing QA on the floor support for in-house manufacturing activities Reviewing and approving master and executed batch records Reviewing and approving method qualification protocols and reports, test methods, certificates of analyses and product stability related activities Overseeing GMP related quality investigations, including input and approval of plans for resolution of product-impacting quality issues; providing oversight of appropriate CAPAs associated with deviations and investigations Providing oversight for the documentation of internal changes Supporting timely batch release. Overseeing the review and approval of all GMP related...

Your experience includes …   Bachelor's or Master's degree in Computer Science, Software Engineering, or related field with 8+ years of industry experience in software, data, and machine learning engineering Proven track record in deploying and auto-scaling ML pipelines for sparse, high-dimensional data across multiple data and model scales Strong proficiency in Python, SQL, and cloud computing platforms (AWS, Lambda, Modal) Extensive experience with ML frameworks such as PyTorch, TensorFlow, or JAX Familiarity in data and model integration techniques built on heterogeneous data types Proficiency in containerization (Docker) and orchestration (Kubernetes, Dagster, Airflow, Slurm) for ML workloads Experience with MLOps tools such as MLflow, Kubeflow, and Ray Solid understanding of engineering best practices including devops, version control systems (Git) and CI/CD pipelines (Jenkins, GitLab CI) It's a bonus if you have: Experience with databases...

Your experience includes…   Bachelor of Science in computer science, data science, or related field with 5+ years of experience (or Masters/3+, PhD) applying an engineering discipline to biomedical research, biotechnology, or computational biology at a scientific research institute or in the biotechnology industry. Proficiency in using Python or another modern programming language Proficiency in SQL and experience in data modeling and database design. Cloud-based software solutions (AWS preferred) and orchestration/integration software (e.g. Dagster, Nextflow). Knowledge of Docker. Software development skills including source control systems and integration/deployment strategies. It's a bonus if you have: Understanding of data management best practices as it relates to biological data. Understanding of modern principles of data analysis as it pertains to computational biology Experience with lab software Benchling (electronic lab notebooks). Experience...

Your experience includes…     MD/PhD or equivalent degree with relevant internal medicine training and board certification +15 years of industry experience in clinical development within a pharmaceutical or biotechnology company.   Designing, implementing, and overseeing multiple early-stage clinical studies, including study start-up activities, medical monitoring and productive partnership with study investigators and clinical research organization staff.   Authoring documents required for clinical studies, including study protocols, investigator brochures, regulatory briefing packages and dossiers to support IND/CTA/CTN. You must have direct experience with IND/CTA submissions.   Thorough understanding of ICH and GCP guidelines to ensure the appropriate conduct of global clinical studies.   Understanding of clinical research methodology and biostatistics principles.   Demonstrated track record of overseeing a clinical team and...

Don't see anything listed that fits your background?  Please use this link to share your profile with us and we will keep you in mind for future roles.   Company Summary: Tessera Therapeutics is pioneering Gene Writing™— a new biotechnology designed to offer scientists and clinicians the ability to write small and large therapeutic messages into the genome, thereby curing diseases at their source. Gene Writing holds the potential to become a new category in genetic medicine, building upon recent breakthroughs in gene therapy and gene editing while eliminating important limitations in their reach, utilization, and efficacy. Tessera Therapeutics was founded by Flagship Pioneering, a life sciences innovation enterprise that conceives, resources, and develops first-in-category companies to transform human health and sustainability. More about Tessera Therapeutics: Tessera is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for...