Sr. Manager, Manufacturing

Vor 4 Tagen

Visp, Schweiz Vaxcyte Vollzeit

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:

  1. 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.
  2. AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.
  3. LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.
  4. MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.

Summary:

As Vaxcyte’s products progress towards late stage and commercialization, Vaxcyte is implementing dedicated biologics manufacturing facilities. This position will support all aspects of manufacturing activities related to Process Validation, commercial Launch, and routine GMP Manufacturing to ensure the efficient and compliant production of Vaxcyte's products.

Working closely with Process Development, MSAT, Supply Chain, Quality, Project Management, Business Development Regulatory functions and with CDMOs; this position will be key in supporting and overseeing all hands-on operations of Vaxcyte’s GMP manufacturing locations. This role will be accountable for timely, compliant, reliable, and uninterrupted supply of Vaxcyte’s innovative therapies. This involves managing the day-to-day production activities to ensure timely and efficient manufacturing of high-quality vaccines. The ideal candidate will have extensive experience in vaccine manufacturing, a deep understanding of CDMO operations, and a strong ability to collaborate across functions to meet client and regulatory expectations. Further, it is mandatory to possess solid knowledge of GxP (GMP, GLP, GCP) regulations as well as expertise in GMP facility operations. Cross-functional teamwork, and successful working with CDMOs is key in this role. This position will report to the Director Manufacturing of Vaxcyte Switzerland.

Essential Functions:

  • Closely monitor and oversee commercial production, implementation and execution.
  • Ensure that production schedules are met, and products are manufactured according to current Good Manufacturing Practice guidelines.
  • Provide technical input to batch records and other quality documents according to ICH and FDA guidelines.
  • Review master and executed batch production records to ensure completeness, accuracy, and compliance with established procedures and specifications.
  • Work closely with CDMOs in setting up and maintaining operational capabilities to maximize reliability of production.
  • Monitor and work closely with the CDMOs for manufacturing deviation investigations and ensure effective CAPA implementation.
  • Identify, recommend, develop and implement necessary changes to improve quality and productivity.
  • Assist in resource planning across programs to ensure adequate resources are available, escalate and resolve issues.
  • Ensure manufacturing operations are running efficiently and that all levels of manufacturing personnel at the CDMOs are appropriately trained and qualified to perform work assigned.
  • Document and monitor key performance indicators, regularly highlighting progress, risks, and mitigation options.
  • Ensure that manufacturing equipment is properly maintained, calibrated, and qualified to guarantee consistent and reliable operation.
  • Work closely with Quality Control and Supply Chain to ensure that raw materials, intermediate products, and finished pharmaceutical products meet quality standards and specifications.
  • Act as deputy for the director of manufacturing.
  • Support tracking of planned and scheduled manufacturing activities at CDMOs to optimize resource utilization.
  • Ensure compliance with regulatory requirements, including GMP, safety and environmental regulations, and other relevant guidelines.

Requirements:

  • PhD in Biological science (Biotechnology, Biochemistry), or MS Degree/Bachelor in Biochemical Engineering.
  • 9+ years of professional management experience in GMP manufacturing and external manufacturing organizations.
  • Excellent team player with outstanding communication skills and a collaborative and supportive manner.
  • Proven leadership experience.
  • Demonstrated ability to work effectively at all levels of a manufacturing organization.
  • Proven hands-on experience in a facility start-up and commercialization environment.
  • Strong organizational, teamwork, interpersonal skills, and professionalism required.
  • Demonstrated hands-on experience for setting up compliant manufacturing facilities, processes, and systems.
  • Proven experience in operating at Large Molecule GMP manufacturing facilities, microbial manufacturing experience desirable.
  • Relentless focus and passion around process quality and improvements (efficiency and automation).
  • Experience managing and adhering to budgets.
  • Ability to balance, prioritize, and resolve conflicts.
  • Manage multiple projects in a fast-paced environment.

Reports to: Director of Manufacturing

Location: Visp, Switzerland

Compensation:

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

Vaxcyte Switzerland GmbH

Rottenstrasse 5

3930 Visp, Valais

Switzerland

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.

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