At Inventprise, developing innovative and widely available vaccines is in our DNA. By producing targeted vaccines for populations worldwide, we're addressing global health inequalities and empowering people to live healthy lives-no matter where they live. Headquartered in Redmond, WA, our goal is to deliver affordable, effective vaccines at large scale to Low and Middle-Income Countries, as well as populations in the U.S. and around the world. Inventprise is committed to creating a diverse and inclusive workplace, where our people are inspired to do their best work. We're proud to have some of the world's most qualified industry scientists, researchers, and manufacturing professionals on our team, and strive to create a vibrant, dynamic presence in the Washington State Life Sciences environment.
What the Role Offers - Scientist
This position involves strong expertise in leading the design and development of a multiple-valency Klebsiella pneumonia polysaccharide-protein conjugate vaccine using state-of-the-art techniques. The qualified applicant leads the overall project and reports to the VP of Viral and Bacterial R&D.
What You Need to Succeed
Research and Development:
Led the development of polysaccharide purification processes and carried out operations with all relevant safety and GLP procedures.
Perform downstream purification involving AKTA chromatography and TFF techniques. Improves polysaccharide yields optimizing purification processes.
Performs and/or analyzes analytical characterization of polysaccharides using HPLC-Reverse Phase/Gel Filtration Chromatography, LC-MS, SEC-MALS, NMR, etc.
Together with the conjugation team, designs and synthesizes bioconjugates involving polysaccharides/proteins or chemical modification of biomolecules with small molecules, functional linkers etc. involving specific chemistries. Improves conjugation inefficiency and product yields.
Designs polysaccharide-protein conjugate vaccines and manages pre-clinical immunology studies.
Develop toxicology and Phase I vaccine batches. Designs and manages stability studies following appropriate regulatory guidelines (WHO, FDA, ICH).
Management:
Generates collaboration, cooperation, and communication across multiple external collaborators, and between internal functional teams (R&D, MSAT, Clinical, Manufacturing, Regulatory, others) to drive project goals and timelines to completion.
Leads a team of internal and/or external scientists and research associates.
Responsibilities associated with the development programs include translating product/program strategy from the department head into efficient executable plans, driving the team to achieve clarity on issues, providing updates to stakeholders as needed.
Identifies and proactively drives high-quality project deliverables, dependencies, and critical path items.
Acts as a GPT lead for the project, presenting periodic advancements to internal functional teams to generate feedback and promote a strong path forward to achieve set goals.
Develops and manages the operational timeline and planning aligned with the project scope, execution strategies and critical paths with support and guidance of the VP of Portfolio Management, GPT sponsor and the executive team.
Additional Functions:
Writing and maintaining documentation of work performed per GDP and cGMP requirements.
Maintain accurate and complete laboratory notebook capturing protocols, results, and observations.
Interpret data to form sound conclusions and perform experimental troubleshooting on a routine basis.
Document integrated experimental outcomes in presentations and research reports in a timely manner.
Communicate work orally, in writing, and in presentation format.
Write and or assist in writing DRBs, SOPs, and other controlled documents in a detailed and accurate fashion.
Contribute to drafting regulatory filing documentation
Required Qualifications:
Educational Pre-requisites:
Master's degree and 8+ years of experience working in either upstream or downstream bacterial fermentation and purification processes.
Ph.D., with experience working in an appropriate field for a minimum of 5+ years.
Experience working with Klebsiella pneumonia is a plus.
Other Required Experience:
Scientific project management experience in the biotechnology or pharmaceutical industries, in a multi-disciplinary, global environment is a plus.
Knowledge and understanding of product development processes, preferably in biologics, and regulatory pathways for biologics (e.g. FDA, EMA, WHO), and knowledge of GDP, cGLP, and cGMP.
Proven ability to communicate and collaborate effectively with senior management.
Proven ability to build strong relationships with internal and external teams.
Excellent prioritization, organizational, and verbal and written communication skills.
Ability to work well with cross-functional teams to accomplish objectives.
PC skills, including MS Word, Excel, Power Point, Visio and SharePoint. Experience working with Smartsheet or MS Project.
Physical Demands:
Must be present on site for all related responsibilities and be able to routinely perform activities as needed.
Must be able to sit and stand unassisted for extended periods of time.
Ability to handle and work with potentially hazardous chemicals per standard operating procedure.
Must be able to lift up to 30 pounds.
Mental Demands:
Excellent oral and written communication skills.
Must maintain a high level of alertness and acuity for analytical review and processing of documentation, daily.
Able to work independently with changing priorities.
Highly organized with an attention to detail
Working Conditions:
Onsite position in Redmond or Woodinville, WA. No remote or hybrid work is available for this position.
Extended periods of time on your feet.Working with chemicals per standard operating procedure.
Working in a warm environment wearing sterile gowning.
Extended periods of time on the computer.
Estimated Base Salary: $133,850 - $156,834 Yearly DOE
Benefits:
Medical, Dental, Vision, FSA, or HSA: Inventprise contributes 80% toward the Medical, Dental, and Vision coverage for the employee, and their enrolled spouse, and dependents. Medical plans are currently provided through Premera Blue Cross.
401(k) program: Inventprise offers both pre-tax 401(k) and post-tax Roth retirement savings plans, letting you decide how you want to save for the future. We also make an employer contribution of 3% of your total earnings each pay period, regardless of whether you contribute.
Paid Time Off: Generous PTO, in addition to paid holidays.
Stock & Bonus Plans: Employees are eligible to participate in the Company's Bonus and Stock plans.
Our People-First Philosophy
At Inventprise, you'll be part of a world-class team working on innovative vaccines and technologies that have global impact. Our people are an integral part of our strategy, allowing us to grow as a company and improve our performance year-over-year.
Our company was built on the belief that by working together, we have the ability to make the world a better place and improve lives. We have a growth mindset and are constantly looking for ways to enhance our contributions to improve global health. We believe that when we support each other and set high standards, we are able to do our best work.
Equal Opportunity Employer
Inventprise is an equal-opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender, identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.