Associate Director of Microbiology and Sterility Assurance

Aquí es donde salvas y sostienes vidas

En Baxter, estamos profundamente conectados por nuestra misión. No importa tu rol en Baxter, tu trabajo tiene un impacto positivo en la gente alrededor del mundo. Sentirá un propósito en toda la organización, ya que sabemos que nuestro trabajo mejora los resultados para millones de pacientes.

Los productos y terapias de Baxter se encuentran en casi cada hospital del mundo, el clínicas y en los hogares. Por más de 85 años hemos sido pioneros en innovaciones médicas significativas que transforman el cuidado en salud.

Juntos creamos un lugar donde somos felices, exitosos y nos inspiramos mutuamente. Aquí es donde puedes hacer tu mejor trabajo.

Únete a nosotros en la intersección de salvar y sostener vidas-donde tu propósito acelera nuestra misión.

Your Role at Baxter
 

This is where your creativity addresses challenges
 

The Associate Director of Microbiology & Sterility Assurance is a quality leadership role responsible for overseeing microbiological practices and ensuring compliance with regulatory standards in our North Cove manufacturing facility. This position plays a critical role in ensuring product safety and efficacy through rigorous microbiological testing, risk assessment, and contamination control within the manufacturing site. The role provides expertise and guidance in interpreting government regulations, guidelines and internal requirements to ensure compliance.
 

Your Team at Baxter
 

Within Quality, every role makes a difference. Products that Baxter makes are shipped worldwide for patients in need. Whether it's building a new process from scratch or facing a never-before-seen production hurdle, individuals within Quality are given the trust and opportunity to bring creativity to the table. Regardless of your specific role with a product, it is sure to touch a portion of our global operation.
 

The mission of Baxter is to save and sustain lives. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds, we will always choose quality. Our patients come first, always.
 

What we offer from Day One

• Medical, Dental and Vision coverage
• 160 hours of Paid Time Off and Paid Holidays
• 401K match
• Employee Stock Purchase Program
• Paid Parental Leave
• Tuition Reimbursement
   

What you'll be doing

• Develop and implement sterility assurance strategies, policies, and procedures for the manufacturing site.
• Develop and implement microbiology strategies, policies, and procedures including environmental monitoring, microbiological testing, and microbial identification; including identification of gaps, resolution of discrepancies, and development of action plans.
• Oversee the microbiology laboratory, including directing a team of microbiology professionals, scheduling, and prioritizing testing activities, and ensuring timely and accurate release of products.
• Ensure compliance with regulatory requirements and industry standards, such as FDA, EMA, PICs, USP and ICH guidelines.
• Assess impact of new regulations and implement appropriate changes as well as lead development of process flows and procedures.
• Maintain the company's sterile manufacturing operations, including cleanroom facilities, sterilization processes, and aseptic processing techniques.
• Provide direct supervision of individuals including mentoring, performance management and staffing decisions. Ability to lead a large team of employees.
• Conduct risk assessments and root cause analyses for sterility assurance and microbiology issues and develop corrective and preventive actions to address them.
• Develop and maintain positive relationships with cross-functional teams, including manufacturing, quality control, and research and development, to ensure effective communication and coordination of microbiology activities.
• Collaborate with cross-functional teams to ensure effective communication and coordination of sterility assurance activities.
• Participate in regulatory inspections and audits and respond to inquiries and observations from regulatory authorities.
• Handles department budget focusing on management of cost controls and cost reduction activities.
• Stay up to date with the latest industry trends, developments, and standard methodologies in sterility assurance and microbiology.
   

What you'll bring

• Bachelor's degree in a scientific field such as microbiology, pharmacy, or biology; Master's or PhD preferred.
• Minimum of 10 years of experience in microbiology, sterility assurance, aseptic processing, or related fields in pharmaceutical or biotech manufa