The Role: / your challenge, 3in our journey

The focus of this job is to lead a group of manufacturing staff in the execution of late-stage clinical and commercial biologics manufacturing operations, including cell culture, purification, and media/solutions preparation. This position requires significant on-the-floor presence and leadership, focused specifically on day-to-day operations using disposable-based manufacturing technologies and ensuring cGMP compliance. Additional job responsibilities may include troubleshooting and/or providing technical expertise, finite scheduling, ensuring staff training compliance, executing against approved written procedures, participating in commissioning and validation activities, maintaining required cGMP compliant systems, and providing support for regulatory and site inspections.

Education and Qualification Requirements

• Bachelor9s degree in biological or engineering science
  15+ years relevant experience

• Technical mastery of cell culture, purification, and solution preparation operations using disposable-based manufacturing technologies

• Proven knowledge of cGMP requirements to ensure compliancePrevious experience managing the activities of both individuals and large groups of staff

• In-depth knowledge of equipment, operations, and engineering principles

• Candidate must 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 mustExcellent oral and written communication skills

Additional Preferred Qualifications

• Strong understanding of process automation (e.g. DeltaV) and BAS systems

• Commissioning and validation experience, including risk assessments, user requirement specifications, execution of DQ, IQ, OQ, and PQ activities, and validation summary reports

• Applies knowledge and expertise to solve complex technical problems

• Significant contributor to multi-disciplinary teams at the functional level

• Mentors and provides technical advice to individuals within the team

• Thorough working knowledge of US FDA CFRs and European EMA, including ICH regulations.

The base pay range for this exempt, salaried position at commencement of employment is expected to be $190,000 to $225,000. Base salary offered may vary depending on the individual9s skills, experience and competitive market value. Additional total rewards include 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.