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Process Development Scientist
11 hours ago
Garuda Therapeutics Watertown, United StatesGaruda Therapeutics, a biotechnology company focused on developing off-the-shelf human hematopoietic stem cell-based cellular therapies, is seeking a highly motivated Scientist to join its growing team. The full-time role will be a key member of the process development team, focu ...
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Process Development Senior Associate
2 weeks ago
Amgen Cambridge, United StatesHOW MIGHT YOU DEFY IMAGINATION? · You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—dri ...
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CMC Process Development Consultant
16 hours ago
Apex Systems Cambridge, United StatesCMC Process Development Consultant · Location: Greater Boston, MA (Hybrid) · Therapeutic Area: Oncology · Job Overview: In this role, the main focus will be on managing CMC processes, coordinating with vendors, overseeing drug substance development, and reviewing various docum ...
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Research Associate, Process Development
2 weeks ago
Moderna Cambridge, United StatesThe Role: · Moderna is working to develop first-in-class messenger RNA (mRNA) based medicines. Were seeking a highly skilled and motivated Research Associate to reside in Modernas Technical Development organization in Norwood, MA. This is a lab-based role that will support the e ...
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Director, Process Development
16 hours ago
Alkermes Watertown, United StatesJob Description · An exciting opportunity for an experienced leader to join as a key member of the Pharmaceutical Development leadership team with responsibility for process development activities within the business, ensuring delivery of robust processes that enable the consist ...
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Process Development Manager
16 hours ago
Alkermes Watertown, United StatesJob Description · The Process Development Manager manages the pilot scale process development facility and personnel and provides technical guidance for small molecule process development, scale-up and technical transfer of developed processes to manufacturing. The successful ca ...
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Process Development Scientist
2 weeks ago
Garuda Therapeutics, Inc. Watertown, United StatesJob Description · Job DescriptionGaruda Therapeutics, a biotechnology company focused on developing off-the-shelf human hematopoietic stem cell-based cellular therapies, is seeking a highly motivated Scientist to join its growing team. The full-time role will be a key member of t ...
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Process Development Engineering Senior Scientist
20 hours ago
Vertex Boston, United States Full timeJob Description · General Summary: · Vertex has established a new research site in Boston Seaport where research, development, and clinical manufacturing for cell and genetic therapies will be primarily based. Cell and genetic therapies represent two rapidly emerging therapeutic ...
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Head of Process Development CMC
2 weeks ago
EPM Scientific Boston, United StatesJob Description · Job DescriptionHead of Process Development · Greater Boston Area | East Coast · Competitive Compensation + excellent bonus/benefits · Duties and Responsibilities: · To be successful in this role, deep understanding of Process Development is required. You should ...
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Integrated Process Development Co-op
4 days ago
Procter & Gamble Boston, United States Full timeDescription · This is a key co-op position in the Integrated Process Development group within the blended Process & Engineering organization of Gillette Blades & Razors business. Our mission is to develop and deliver robust, in control, on target, and capable processes that sust ...
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Director, Process Development
2 weeks ago
Arbor Biotechnologies Cambridge, United StatesWho are we? · We are a next-generation gene editing company focused on discovering and developing potentially curative genomic medicines, with the most extensive toolbox of proprietary genomic editors in the industry. We have the unique ability to work backward from disease pat ...
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Process Development Senior Principal Scientist
2 weeks ago
Amgen Cambridge, United States Full timeHOW MIGHT YOU DEFY IMAGINATION? · If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who ...
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Contract - Engineer 1, Process Development
3 days ago
Vedanta Biosciences Inc Cambridge, United StatesTitle: Contract - Engineer 1, Process Development (~6-9 months) · Location: Cambridge, MA · Reports to: Senior Scientist, Process Development · About Vedanta Biosciences: · Vedanta Biosciences is a late-stage biopharmaceutical company developing medicines for the treatment of ga ...
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Executive Director, PSC Process Development
1 week ago
Sana Biotechnology, Inc. Cambridge, United StatesAbout the role · Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of engineered cells as medicines, who want to challenge status quo, and who lead with the desire to translate novel ideas into clinical product. As the Head of Pluripo ...
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Process Development Associate Process Chemistry
2 weeks ago
Amgen Cambridge, United States Full timeHOW MIGHT YOU DEFY IMAGINATION? · Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives ...
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Process Development Scientist
2 weeks ago
Amgen Cambridge, United States Full timeHOW MIGHT YOU DEFY IMAGINATION? · Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives ...
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Process Development Scientist
5 days ago
Amgen Cambridge, United States**HOW MIGHT YOU DEFY IMAGINATION?** · You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience, and passion to work toward your goals? At Amgen, our shared mission—to serve patient ...
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Process Development Scientist
5 days ago
Garuda Therapeutics, Inc. Cambridge, United States**Key Responsibilities Include**: · - Culturing human pluripotent stem cells in various conditions, aiming to scale up expansion and differentiation · - Validation and qualification activities to support the qualification of single-use bioreactors · - Implementation of closed-sys ...
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Scientist - Process Development
3 days ago
Thermo Fisher Scientific Cambridge, United StatesThermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission - to enable our customers to make the world healthier, safer, and cleaner. · Within our Anal ...
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Process Development Scientist
2 weeks ago
Amgen Cambridge, United States Paid WorkHOW MIGHT YOU DEFY IMAGINATION? · You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—dri ...
Associate Director, Drug Substance Process Development - Cambridge, United States - Sail Biomedicines
Description
Associate Director, Drug Substance Process DevelopmentSail Biomedicines is harnessing evolutionary and artificial intelligence to revolutionize programmable medicines. Sail's platform combines first-in-class programmable RNA technology (Endless RNA TM
or eRNA), and an industry-leading platform of programmable nanoparticles, utilizing natural components, to unlock comprehensive programming of medicines for the first time.
By leveraging cutting-edge eRNA and nanoparticle deployment technology, Sail is building a wealth of data, enabling unparalleled use of AI techniques to identify and design fully programmable medicines that are potent, targeted, versatile, and tunable.
Sail was founded by Flagship Pioneering.The Role:
Sail Biomedicines is seeking a highly motivated and innovative
Associate Director , Drug Substance Process Development to be the subject matter expert and leader of RNA manufacturing processes, including upstream and downstream activities.
As a leader within the Technical Operations department, you will oversee and actively contribute to the development of drug substances (RNA) processes for scale-up and clinical manufacturing, as well as supporting internal efforts for preclinical supply and overall platform process understanding.
You will closely collaborate across the entire organization, including process development, platform, applications, strategy, and supply chain functions to advance our programmable medicines.
ResponsibilitiesLead and mentor a team of scientists developing novel processes for eRNA manufacture to enable process efficacy, scalability and delivery of high-quality drug substance.
Interface with the Platform, drug product process development, internal preclinical & external clinical manufacturing, and analytical development teams to enable harmonization of processes.
Establish scalability of the process and a path to establishing a platform process across all programs.Define drug substance related process design space, including product and intermediate stability.
Develop IVT and purification approaches to produce drug substance of appropriate quality attributes.
Design, lead and drive experiments for screening, optimization and scale-up of all RNA based methods, leveraging DoE, including IVT, chromatography and filtration separations.
Contribute to regulatory engagements and filings for clinical stage programs.Oversee the transfer of processes to internal production team and external CDMOs.
Apply and develop state-of-the-art technologies and solutions using novel processes and translatable industries.
Develop, refine and deploy unit operations for enzymatic reactions; characterize enzymatic reactions using first principles.
Co-develop characterization methods with analytical team to assess quality of the material
Troubleshoot lab workflows, maintain equipment and support IND enabling manufacturing batches.
Qualifications:
PhD 6+, MS 10+, BS 12+ years of industry experience or equivalent experience in bioengineering, chemical engineering, biology, virology, biochemistry or related field
8 years leading/mentoring scientific staff, within the process development space.
Expertise in biologics Purification development such as nucleic acids protein, and/or AAV
Experience leading cross-functional and CMC sub-teams through direct and indirect reporting structures
Expertise in novel therapeutics-focused platforms and modality technologies preferred.
Experience delivering on strategic timelines and executing successfully on corporate goals
Expertise in nucleic acid synthesis, purification, enzymes, manufacturing, analytics and/or formulation
Hands on experience using separation instruments like HPLC, AKTA and TFF
Experience and/or understanding in nucleic acid chemistry, enzymatic reactions, PCR, plasmid processing and standard analytical techniques
Experience with custom affinity resins and knowledge of continuous processing applications.
Sail Biomedicines is an Equal Opportunity Employer.
Sail does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, national origin, veteran status, or any other status protected under federal, state, or local law.
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