Associate Director, Formulation Development

Join our Mission to Protect Humankind! Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, periodontitis and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance. WHAT we do is every bit as important as HOW we do it! Our work together is guided by four enduring core values: *RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered. *AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind. *LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives. *MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.

Summary

Vaxcyte is looking for an energetic and talented individual to join our Formulation and Drug Product Development team.

The candidate will have extensive knowledge and practical experience in formulation development of biologics and/or vaccines, preferably adjuvant containing formulations, complemented with a broad range of vaccines analytical techniques and in particular in-depth experience in biophysical characterization of formulations. The candidate will have a strong industry-based experience in bringing a product from early to late-stage development, including process scale-up, manufacturing and the preparation of regulatory submission sections (IND, CTD, and BLA). Having worked with external analytical and manufacturing CMOs would be beneficial as well as a good understanding of GxP testing and manufacturing guidelines.

Essential Functions

• Primary responsibility will be to lead the Formulation Team in facilitating formulation development activities across all our programs, leading scientific interactions with the project, Analytical, Drug Substance (DS) and Drug Product (DP) team members to move all programs though the development phase into phase 1, 2, 3 clinical trials and into preparations for commercial launch.
• Lead a team of scientists to support the formulation development activities, including formulation screening, stability studies for thermal, freeze/thaw, shipping studies, agitation as well as container closure system evaluation for bothDS and DP materials.
• Play a pivotal role in supporting investigations related to quality issues, deviations, out-of-specification results, and anomalies at all stages of vaccine drug product development, from early development to late-stage phases. These investigations will rely on the robust application of Design of Experiment (DoE) methodology and the utilization of a wide array of analytical techniques.
• Apply biophysical characterization techniques to fully understand antigen/adjuvant interactions and to assess formulation matrix optimization options.
• Coordinate day-to-day laboratory activities and experiments of the Formulation Development Group, ensuring sufficient resource coverage and performance to meet scheduled turnaround times for formulation development deliverables. Identify of project scientific needs and gaps, including conceptual design, planning, execution through the team, data analysis and next-step proposal to both the DP and wider Project Team.
• Track stability data and provide regular updates on developmental and official stability studies to ensure timely communication of findings and necessary adjustments.
• Collaborate closely with DP management and external Vaxcyte Team members and to ensure supply/demand, in vivo, DS quality, analytical methods, CMO status and timelines are all in sync with formulation development activities to hit milestones as needed.
• Prepare protocols and write detailed reports on formulation development activities, data analysis, and outcomes, ensuring clear communication of results and recommendations.
• Prepare sections of regulatory submission documents, including IND, CTD, and BLA, as needed, ensuring accuracy, compliance, and alignment with regulatory expectations.
• Engage with external CDMO partners to support process development, stability studies, and both non-GMP and GMP manufacturing activities as needed, ensuring alignment with project timelines and regulatory requirements.
• Must have people management experience, as this role will have 3-4 direct reports. Will be responsible for developing and mentoring junior scientists scientifically and professionally to support their career advancement.
  
  
  

Requirements

• PhD. in Pharmaceutics, Chemistry, Biophysics or Biochemistry with 8 years of relevant experience or a MSc. in Pharmaceutics, Chemistry, Biophysics or Biochemistry preferred, with 12 years of industrial experience.
• The candidate should have had extensive experience in developing proteins, polysaccharides and/or protein conjugates formulations for vaccines, preferably vaccine systems containing adjuvants (other non-vaccine biological experience also considered).
• Proficient in using biophysical and calorimetric techniques for proteins and protein-polysaccharide conjugates, including Circular Dichroism, Fourier Transform Infrared (FTIR) Spectroscopy, Fluorescence Spectroscopy, Differential Scanning Calorimetry (DSC), and Isothermal Titration Calorimetry (ITC).
• Experience in leading stability studies and investigating quality issues, deviations, out-of-specification results, along with using DoE for complex system optimization is required.
• Experience of manufacturing within GxP environments either directly or through CMOs
• Ability to move and multitask seamlessly between complex programs and project teams is required.
• Strong scientific leadership is required: critical thinking, ability to present complex data sets and to independently propose and design follow-up experiments.
• Must have excellent scientific judgement, independence, rigor and thorough record keeping.
• The candidate should have high degrees of both flexibility and organizational skills as well as an eagerness and ability to learn to effectively navigate multiple projects and timelines.
• Strong interpersonal skills: ability to communicate effectively both verbally and in written formats (must be able to work with managerial and lab team in remote setting when needed) are necessary to collaborate effectively with the rest of the Formulation and Drug Product Development team and well as across other teams.
• Must be detail oriented, rigorous, with excellent documentation skills.
• This role requires to be in office 3 to 4 days a week with flexible working hours.
  
  
  

Reports to: Director, Formulation Development

Location: San Carlos, CA.

Compensation

The compensation package will be competitive and includes comprehensive benefits and an equity component.

Salary Range: $186,000 - $218,000

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.