Jobs
>
Boston

    Sr. Scientist, Upstream Process Development - Boston, United States - EPM Scientific

    Default job background
    Description

    Job Description

    SUMMARY

    This company is searching for an imaginative scientist knowledgeable in Upstream Process Development to manage all upstream technical tasks for their primary vaccine program. The chosen candidate will work hands-on in the lab with hybrid flexibility, overseeing CRO/CDMOs to ensure compliance with QbD and cGMP requirements.

    RESPONSIBILITIES:

    • Design, develop, and implement fermentation & cell culture techniques, protocols, and technologies.
    • Assist in scaling up, transferring technology, optimizing, and validating upstream cell culture and viral vector unit operations.
    • Monitor CDMOs for deliverables and timelines for upstream tech transfer.
    • Act as an expert for all upstream drug substance activities supporting clinical development and IND filing.
    • Collaborate with the technical team and CDMO partners on process design, optimization, and characterization.
    • Write and review CMC sections & technical reports for regulatory submissions.

    QUALIFICATIONS:

    • Master's or PhD in Chemical Engineering, Microbiology, Biochemistry, or related field with 4-5 years of industry experience (PhD) or (MS +8 years) in upstream processes.
    • Experience with viral vaccines, insect/mammalian, & recombinant proteins preferred.
    • Track record of managing deliverables internally and externally.
    • Understanding of ICH Q8 criteria and quality by design concepts.
    • Expertise in statistical software (JMP, R, etc.) for DOE and data presentation.

    BENEFITS

    • Hybrid Flexibility (3-4 days)
    • Unlimited PTO
    • 401k & Stocks
    • Medical, Dental, Vision, Insurance
    • MUCH More


  • Thermo Fisher Scientific Cambridge, United States

    Thermo 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 ...


  • 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 ...


  • Vertex Pharmaceuticals Boston, United States

    **Job Description**: · The Process Dev Engineering Scientific Associate will be part of a team responsible for the development, optimization, and characterization of cell culture processes for ongoing and future projects. · **Thursday-Monday Shift** · **General Summary**: · The P ...


  • 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 patients ...


  • Ensoma Boston, United States

    We are seeking a motivated and experienced Upstream Process Development Scientist to lead process development efforts for cutting edge adenoviral vector production processes, and implementing them in manufacturing. · You will join a team of scientists and engineers dedicated to b ...


  • 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 ...


  • 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 ...


  • Eclipse Innovations Beacon Hill, United States

    Beacon Hill is a specialist for plastic components in the fields of pharmaceuticals, diagnostics, and medical technology, located in Bad Oeynhausen. Since 2016, Beacon Hill has been a part of the Italian Stevanato Group, with over 5,000 employees worldwide. · Passion – Spirit – ...


  • Asimov Boston, United States Full time

    We are seeking a Head of Process Development to develop exceptional upstream mammalian bioprocess platforms for diverse therapeutic modalities. You will be an in-lab leader for a growing team that is responsible for designing, executing, and optimizing cell culture processes usin ...


  • Arbor Biotechnologies Cambridge, United States

    Who 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 ...


  • Amgen Cambridge, United States Full time

    HOW 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 ...


  • Amgen Cambridge, United States Paid Work

    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 patients—dri ...


  • Amgen Cambridge, United States Paid Work

    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 patients—dri ...


  • HireMinds Boston, United States

    Director, Bioprocess Development · Boston, MA · Our vaccine client in Boston, MA is looking to add a hands-on, Director, Bioprocess Development (Microbial/Fermentation) to their team This role will work on-site, in the lab to lead the development of scalable processes for CMC dev ...


  • Amgen Cambridge, United States Full time

    HOW 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 ...


  • EPM Scientific Boston, United States

    Job 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 ...


  • Moderna Norwood, United States

    **The Role**: · Moderna is seeking a veteran biotechnology leader with deep experience in the development of biopharmaceutical manufacturing processes to assume the Head of Process Development, Delivery role. This critical position is responsible for leading a diverse and high-fu ...


  • Amgen Cambridge, United States

    **HOW 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 patientsd ...


  • Radiant Ventures Mendon, United States

    Founded in 1980, IMS Messsysteme GmbH is now the world leader in X-ray, isotope, and optical measurement systems with headquarters in Heiligenhaus (NRW) and branches around the globe. The top 20 largest steel and aluminum manufacturers worldwide trust our innovative, high-precisi ...


  • Federal Reserve Bank of Boston Boston, United States Full time

    Company · Federal Reserve Bank of Boston · We are seeking a talented robotic process automation developer to join our growing Automation Team at the Federal Reserve Bank of Boston. In this role, you will take ownership of the automation opportunities to deliver innovative, scalab ...