Develop and execute a comprehensive global manufacturing strategy that aligns with the company's mission and objectives
Develop/Build a scalable manufacturing organization to meet the corporate goals
Provide strategic leadership to the global manufacturing organization, ensuring the team is equipped to meet current and future challenges
Foster a culture of quality and compliance throughout the organization
Manage site performance, ensuring operational excellence;
Review and approve GMP controlled documentation, ensuring that they meet technical and regulatory requirements;
Plan staff and equipment operations scheduling;
Successfully execute advanced biologics manufacturing technologies;
Troubleshoot and/or provide technical expertise to perform or lead investigations;
Assist in the generation of relevant regulatory submissions; implementation and/or maintenance of cGMP compliant systems;
Provide support for regulatory and site inspections,
Manage OPEX and CAPEX budgets; develop a culture of continuous improvement;
Incorporate and expand sustainability into manufacturing operations;
Build and develop staff for future roles and career progression;
Ensure a culture of safety.

Requirements

PhD or Master’s degree in biological or engineering science with 15+ years relevant experience or
Bachelor’s degree in biological or engineering science with 20+ years relevant experience
Extensive experience in late-stage/commercial biologics drug substance manufacturing
Technical mastery of cell culture and purification operations at commercial scale
Proven knowledge of cGMP requirements to ensure compliance
Advanced skills in the operation of single-use technologies, including cell culture, purification and drug substance filling operations
Validation experience, including risk assessments (SIA and CIA), user requirements, design qualification, installation qualification, operational qualification, performance qualification, and validation summary reports
Strong understanding of process automation (e.g. DeltaV) and BAS systems
Experienced in the use of electronic systems such as QMS, MES/EBR, CMMS, and ERP systems
Previous experience managing the activities of individuals, work groups, and project teams.
Possess strong focus on quality and attention to detail
Possess effective task/time management organizational skills
Motivated, self-starter with strong mechanical aptitude
Good interpersonal, team, and communication skills are a must
Excellent oral and written communication skills
Strong computer skills include Microsoft Office (Word, Excel, Power Point, and MS Project)

Benefits

discretionary annual bonus
comprehensive benefits to include Medical, Dental and Vision
short-term and long-term disability
company paid basic life insurance
401k company match
flexible work
generous paid time off and paid holiday
wellness and transportation benefits

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

biologics manufacturingcell culture operationspurification operationsdrug substance filling operationscGMP compliancevalidation experienceprocess automationrisk assessmentssingle-use technologiescontinuous improvement

Soft Skills

strategic leadershipquality focusattention to detailtask managementorganizational skillsinterpersonal skillsteam skillscommunication skillsself-startermechanical aptitude

Certifications

PhD in biological sciencePhD in engineering scienceMaster’s degree in biological scienceMaster’s degree in engineering scienceBachelor’s degree in biological scienceBachelor’s degree in engineering science