- Develop early-stage DP manufacturing processes including aspects relating to scale-down model development, characterization, and scale-up of unit operations for parenteral manufacturing (i.e. filling, filtration, mixing, etc.).
- Enable the team in general process design, including contact material selection, hardware design/construction, filter selection/sizing, mixing and filling activities at the phase 1 scale and in down scaled models.
- Aid in oversight of the fill finish CMO service provider to support early, late, and commercial stage manufacturing deliverables and fill/finish process development.
- In concert with the CMC team and external guidance, aid in late-stage process characterization and process validation.
- Lead all aspects of and engage in the planning, design, execution, and documentation of DP fill/finish process development studies.
- Collaborate with the DP Formulation Team to troubleshoot and optimize the DP as required for phase 1, 2, 3 and commercial needs.
- Drive continuous improvement in DP development process through technological innovation and application of first principles in process engineering.
- Participate in process development activities for commercial drug product manufacturing operations during sterile processing, process characterization, tech transfer, process validation, and ongoing commercial manufacturing.
- Assist in developing control strategies for DP unit operations and oversee the creation of clinical manufacturing processes to assess the viability of commercial processes.
- Apply statistical/data analytics techniques to draw conclusions and make informed decisions.
- Guide the development of junior engineers, fostering their growth through active leadership and supervision.
Requirements: - Bachelor's Degree and >8 years of experience, Master's Degree and >6 years of experience in scientific/process development experience. BSc or MSc in Chemical Engineering, Pharmaceutical Sciences, the physical sciences, or a related field preferred.
- Experience in clinical/commercial manufacturing within fill finish sites and understanding of Quality systems and Drug Product Manufacturing under GMP regulations preferred.
- Background in manufacturing process development and process validation of parenteral drug product, including applying QbD principles and knowledge of pharmaceutical science to overcome challenges around DP manufacturing and scale up.
- Experience in the development of scaleup/down models for DS or DP processes.
- Strong interpersonal and leadership skills; ability to communicate effectively both verbally and in written formats.
- Ability to work within in a fast-paced, cross functional environment, multitasking as needed.
- Ability to lead the design of drug product process development and characterization experiments while adhering to scientifically-sound practices, including the design, execution, review, and interpretation of experiments.
Reports to: Group Leader, Drug Product Engineering
Location: San Carlos, CA
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $152,000 – $170,000 -
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Sr. Engineer, Drug Product Process Development - San Carlos, United States - Vaxcyte, Inc.
Description
Join our Mission to Protect HumankindVaxcyte 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:
*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.
*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.
*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 the Drug Product Development (DP) team. The primary responsibilities for the incumbent will be to support the DP process development of pre-clinical programs through to the phase 3 and commercial readiness. This position will require the candidate to develop scalable and scaled manufacturing process for Vaxcyte's vaccine portfolio, being highly complex biological products.
Due to the high number Drug Substances within the DP and a suspended adjuvant system, this is arguably one of the most complex Drug Products in clinical development, so it is an incredible opportunity for the right candidate to make a significant impact on the product, the company, and the industry. The candidate will need to relish the scope and size of this unique challenge. In addition, our pre-clinical vaccine program, VAX-A1, is moving into a period of high intensity focus in preparation for GLP and GMP work.
Essential Functions:
