Work ScheduleStandard (Mon-Fri)
Environmental ConditionsAble to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Loud Noises (Equipment/Machinery), Office, Rapid flashing lights, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift, Strong Odors (chemical, lubricants, biological products etc.), Will work with hazardous/toxic materials
Job DescriptionDESCRIPTION:
Guide a collaborative team in manufacturing high-quality pharmaceutical and diagnostic products while ensuring compliance with cGMP standards and regulatory requirements. Support operational excellence through effective resource management, process optimization, and continuous improvement initiatives. Collaborate across teams to meet production goals, maintain quality standards, and deliver products on time. Support a culture of safety, quality, and innovation while developing team members' capabilities and fostering engagement.
REQUIREMENTS:
• Advanced degree plus 6 years of experience
• Bachelor's degree plus 8 years of experience, in cGMP manufacturing environment, preferably in pharmaceutical or diagnostic manufacturing
• Preferred Fields of Study: Chemistry, Engineering, Life Sciences, or related scientific/technical field
• 3+ years of demonstrated management/leadership experience supervising manufacturing teams
• Strong understanding of cGMP regulations, quality systems, and regulatory compliance requirements
• Demonstrated success in operational excellence and continuous improvement initiatives
• Experience with manufacturing documentation, batch record review, and change control processes
• Ability to conduct investigations, implement CAPAs, and support quality improvements
• Strong project management and organizational skills to manage multiple priorities
• Skilled in cross-functional collaboration and stakeholder management
• Strong verbal and written communication skills in English
• Proficiency with ERP systems, Microsoft Office suite, and quality management software
• Ability to work in cleanroom environments and comply with gowning requirements
• Physical capability to stand for extended periods and occasionally lift up to 25 lbs
• Ability to work various shifts including nights/weekends as business needs require
Location, Work Authorization & Pre-Employment RequirementsPlease review the following requirements before applying:
- Relocation: Relocation assistance is not available for this position.
