Manager, Gliadel Manufacturing (Direct Hire Role)
Leads and directs Gliadel Polymer Manufacturing operations and serves as Gliadel technical resource for projects, regulatory submissions, and continuous improvement efforts. Ensures compliance with global GMPs, local Standard Operating Procedures (SOPs), and operational best practices to manufacture polymers which are then used for the production of Gliadel. Manages utilization of people, equipment, and materials to continuously improve the operation by increasing quality and responsiveness while eliminating waste and reducing costs. Serves as a site resource for innovation and improvement efforts and provides guidance and support to the Process Engineer and site. Interfaces regularly with regulatory agencies during inspections
Technical expert on Gliadel Polymer production processes. Assists with regulatory inspections 30%
Partners with other internal groups (Quality, Facilities, Cleanroom and Technical Operations) as well as external organizations to develop business plans for both short-term and mid-term timeframes. This includes project execution, issue resolution, skill enhancement, resource allocation, training, process improvement and overall alignment with the Brand and Company goals. 20%
Uses innovative approaches to identify and implement improvements to equipment, processes, and documentation. This results in a more effective and efficient operation as well as additional opportunities for employee growth within organization. This extends beyond Polymer manufacturing area to include scope of entire Gliadel operation as needed. 20%
Mentors and provides coaching and development opportunities to staff to develop and retain talent. Focuses on employee engagement, satisfaction, development and accountability. 20%
Other duties as assigned to facilitate ongoing Gliadel production and/or operational activities.
• Manages Polymer production operations
• Routinely makes independent decisions which impact the quality and safety of product as well as GMP compliance of the area.
• Supports strategic relationships with internal and external customers/business partners.
• Responsible for talent development and employee engagement of team.
• Empowers and supports employees by encouraging strategic thought and independent judgment.
• B.S. Degree in engineering, pharmaceutics, or related science discipline
• 8+ years’ experience in the pharmaceutical industry with previous operations supervision experience. Strong track record of safety and quality results and measures.
• Experience interacting with regulatory inspectors preferred.
• Excellent communications and interpersonal skills.
• Lean, six sigma certification preferred
Previous small molecule manufacturing and/or Cleanroom manufacturing operations experience strongly desired in either commercial or research/clinical environment.
• Demonstrated ability to operate effectively in a multi-faceted, multi-cultural, and global environment and influence and lead global teams
• Thorough knowledge of FDA, ICH, EU, and other global regulations and GMP guidelines.
• Proven abilities to influence, lead, and supervise individuals and teams effectively, including coaching and directing supervisors.
• Ability to engage, develop, and retain personnel and build organizational depth
• Demonstrated analytical, problem-solving, critical thinking and effective decision making skills
• Demonstrated boundary spanning skills
• Strong verbal, presentation, organization, writing, project management, multi-tasking and troubleshooting skills.
• Ability to read, understand, interpret, and apply technical writing and instructions.
• Pertinent technical operations, business, and financial skills
• Working knowledge of supply chain functions and interrelationships and dependencies.
• Only local candidates should be sourced (i.e., within one hour rush hour driving time for the Baltimore site as answering alarms off hours may sometimes be required). There is no relocation allowance.
• Candidates with GMP/pharmaceutical background required
• Prior management experience required
• Prior experience in Process Engineering, Lean Six Sigma, Kaizen would be a plus
• Chemistry background "strongly" preferred, but will balance with prior GMP Manufacturing management experience
• Prior manufacturing/cleanroom/sterile product experience required
• Excellent communications skills (both written and verbal)
• No VP levels or someone who wants to get to VP level here. Small organization with lots of opportunity for innovation and improvement.
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