Scientist – Formulation and Product Development (Ready to Administer Products)

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• Scientist - Formulation and Product Development (Ready to Administer Products)
  
  

VitriVax, Inc. Scientist - Formulation and Product Development (Ready to Administer Products) Boulder, CO

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Apply for Scientist - Formulation and Product Development (Ready to Administer Products)

VitriVax, Inc. is creating thermostable, single-injection vaccines using an innovative technology platform called ALTA®. Fundamentally, ALTA® products are formulations of antigens, adjuvants, or nucleic acids that use an innovative manufacturing process combining particle engineering technologies from the pharmaceutical and semiconductor industries. Thermostable, single-injection products will revolutionize the vaccine industry and have attracted significant industry, government, and philanthropic interest. Learn more about VitriVax by visiting our website, https://vitrivaxbio.com/. If you are interested in joining VitriVax, Inc. we are always looking for talented individuals. Below is one opportunity we have open to help make vaccines assessable to everyone. See all opportunities at https://vitrivaxbio.com/. Scientists in Formulation Development supporting the Product Research and Development (PRD) group are responsible for the 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 and experience performing physiochemical characterization to inform formulation strategies. Additionally, this position will focus on preparing ALTA® products for ready-to-administer presentations (e.g. liquid suspension in pre-filled syringes or dual chamber devices). Integrity of the coating and active stability within formulations must be investigated in potent ALTA® products with low API content and an ALD coating designed to provide delayed release. This role will assist formulation and product development teams and report to the Head of Product Research and Development. Scientists are expected to work independently and use their judgement to design studies that address project team and functional area goals. Scientists are also expected to train and oversee research associates and newer scientists. This is a full-time position, located in Boulder, Colorado.

Description

Responsibilities and Duties:

• In-house subject matter expert for formulation development for a broad range of APIs
• Independently research, design, and execute studies of various ready-to-administer sterile injectable product formats, containers, and diluents to evaluate viability and stability of ALTA® suspensions and the contained APIs.
• Works effectively and dynamically in cross-functional teams to prepare and analyze formulations which promote API stability and meet spray drying and ALD coating requirements.
• Helps train PRD staff and coordinates research associates to address project needs.
• Prepares study reports and presents data to teams, partners, and executives.
• Works closely with Quality Assurance, Particle Characterization, and Analytical Research groups to establish specifications.
• Analytical resource for advanced characterization of biological materials and ALTA® coatings.
• Clearly communicates and collaborates to conduct investigations of ALTA® processes and products.
• Maintains equipment and ensures that methods and equipment are fit-for-purpose.
• Supports Quality Control testing to support product release and stability testing.
• Contributes toward portions of IND or BLA eCTD module 2 and 3.
• Adheres to Company policies and laboratory notebook and safety guidelines
  
  

Education And Experience Requirements

• Must be able to perform the responsibilities and duties listed above.
• A PhD degree with relevant dissertation research, Master’s Degree with 3 years relevant industry experience, or a Bachelor’s Degree with 5 years relevant industry experience.
• Experience evaluating suspension stability, ease of resuspension/caking, injection force, dosing uniformity, and extractables and leachables as a function of diluent and container properties required.
• Experience designing protein or nucleic acid formulations for lyophilized or spray dried products or for delayed release products highly preferred.
• Supervisory experience or cross functional team leadership
• Chromatographic (RP, SEC, IEX, GC), spectroscopic is required
• Analytical training including advanced characterization of proteins, lipids or nucleic acids
• Experience with particle characterization, dissolution, ELISAs, and other biochemical techniques preferred
• 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 as a Scientist or Senior Scientist. The level will be determined by the applicant’s experience and alignment with current and future responsibilities.

• Scientist: PhD in an academic program aligned with VitriVax needs – range $100,000 to $140,000 annual base (dependent on experience)
• Senior Scientist: PhD 5 years in an academic program aligned with VitriVax needs – range $130,000 to $170,000 annual base (dependent on experience)
  
  

All full-time employees are eligible for the following benefits.

• Stock options.
• 401(k) with generous Company match
• Flexible work schedule
• Generous PTO
• 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.

Salary

$100,000 - $170,000 per year

Apply for Scientist - Formulation and Product Development (Ready to Administer Products)