Scientists in Formulation Development are responsible for design of formulations that stabilize active pharmaceutical ingredients during both ALTA™ manufacturing and product storage. The Formulation Development Scientist should have advanced knowledge of protein structure or nucleic acid/lipid nanoparticles. An additional challenge is stability must be investigated in potent ALTA™ products with low API content and an ALD coating designed to provide delayed release. This role reports to the Head of Product Development and could be asked to lead a product development team. Scientists are expected to work independently and use their judgement to design studies that address project team and functional area goals.

This is a full-time position, located in Boulder Colorado.

Responsibilities and Duties:

• In-house subject matter expert for formulation development for a broad range of APIs
• Analytical resource for advanced characterization of biological materials
• Independently researches, designs, executes and reports study plans and stability protocols to evaluate formulated materials.
• Conducts investigations of ALTA™ manufacturing processes.
• Performs Quality Control testing to support product release and stability testing.
• Works closely with Quality Assurance and Analytical Research to establish specifications.
• Contributes toward portions of IND or BLA eCTD module 2 and 3. 
• Able to lead, collaborate, and work dynamically in cross-functional teams to complete partner projects on aggressive timelines
• Helps train Product Research and Development staff to address project needs.
• Adheres to Company policies and safety guidelines

Education and Experience:

• Must be able to perform the responsibilities and duties listed above.
• A PhD degree with dissertation research characterizing and/or formulating biological materials, or a Bachelor’s Degree with 10 years relevant industry experience in formulation.
• Spectroscopic and chromatographic (HPLC) knowledge is required
• Experience with ELISAs, particle characterization, CE, ELSD, and formulation development for spray dried/lyophilized products preferred.
• Analytical training including advanced characterization of proteins, lipids or nucleic acids
• Supervisory experience or cross functional team leadership
• Understanding of ICH Q8, Q9 and Q10 and Quality by Design.
• Statistical analysis required, proficient using Excel, Word and other office tools.

Core Skills and Competencies

All VitriVax employees are expected to share the following values and skills.

Integrity

We are team players who say what we do and do what we say. We respect our obligations and are transparent in our communication. We present all data factually. When presented with ambiguous situations, we strive to do the right thing.

Innovation

We create value by developing superior products and processes. We have a curious mindset, apply an analytical approach and take calculated risks. We take on difficult problems and break barriers.

Passion

We are passionate about making vaccines accessible to everyone. We share our enthusiasm with purpose.  We are never satisfied with the status quo and want to make a difference.

Quality

We seek quality information, decisions and people. We put safety first and approach every opportunity with a right first-time mindset that is focused on the end goal. We are committed to continuous improvement and elimination of waste.

Salary and Benefits

The position may be filled at the Senior Scientist or Scientist level. The level will be determined by the applicant’s experience and alignment with current and future responsibilities.

• Senior Scientist: PhD + 5 years in an academic program aligned with VitriVax needs – range $125,000 to $170,000 p/a
• Scientist: PhD in an academic program aligned with VitriVax needs – range $100,000 to $125,000 p/a

Benefits

• Stock options.
• 401(k) with generous Company match
• Flexible work schedule
• Health, Dental and Vision insurance
• Short Term Disability insurance

VitriVax, Inc., is an Equal Opportunity Employer and does not discriminate based on race, color, gender, sexual orientation, gender identity or expression, religion, disability, national origin, protected veteran status, age, or any other status protected by applicable national, federal, state, or local law.

VitriVax, Inc., requires all staff to be vaccinated against communicable diseases as recommended by the CDC prior to employment