Biomanufacturing Engineer (III) / Sr. Specialist - Cell Therapy
This position is responsible for on the floor oversight (Person in Plant) of one of Our Client's contract manufacturing organizations (CMOs) located in the Memphis Tennessee area.
The incumbent will partner with internal and external stakeholders to drive production activities for clinical and commercial Cell Therapy (drug substance / drug product) products.
Responsibilities include operational support of production activities (batch production, record review, document revisions, training) and quality management systems (deviation investigations, change management, and product disposition) all in accordance with good manufacturing practices (cGMP).
Reporting to the Sr. Manager, External Manufacturing, he / she will provide the oversight, support, and results focus to reliably meet and / or exceed the company's manufacturing goals while maintaining high levels of quality.
The incumbent will also be responsible for implementing and maintaining defined operational excellence tools and metrics.
This position requires an individual capable of partnering across and outside the organization to manage a complex cell therapy manufacturing process and deliver transformative medicine to patients.
This position is in Memphis Tennessee and will have direct in-person oversight (Person in Plant) for cell therapy manufacturing at a CMO located in Memphis Tennessee.
Working in a in a cleanroom facility, ensuring adherence to established procedures and compliance to cGMP's. Will require work during non-standard working hours and / or weekends (during campaigns).
Lead after action review meetings (immediately following production runs), documenting outcomes and tracking action items to closure.
Working closely with CMO to identify and track to closure all open items / corrective actions.
Perform manufacturing review of executed batch records and discrepancy documents. Provide operational SME input into the resolution of non-conformance events.
Closely partner with CMO and Quality Assurance group, manage and ensure the timely production, review, and release of product.
Through frequent presence on site, establish professional and technical credibility and build sustainable, positive relationships to achieve defined program objectives.
Proactively identify, assess, and mitigate quality, operational, and organizational risks; escalate key risks and issues.
Provide on-site support during regulatory inspections.
Review and / or author technical and project protocols / plans and reports in support of technical studies, stage gate reviews, and global regulatory filings.
Continuous Improvement / Operational Excellence
Partner with technical teams and program management to facilitate technical transfer of processes to new CMOs including development / revision of batch records and procedures, management of change controls, and establishing process and equipment training programs.
Monitor CMO goals, individual goals, and key performance indicators in alignment with company goals; maintain and report applicable metrics / milestones.
Proactively respond to key performance indicators and drive continuous improvement initiatives that improve contract manufacturer performance (safety, quality, and cost).
Other duties as assigned.
Education and Experience
Bachelor's degree and 4-6 years of related pharmaceutical / biopharmaceutical work experience.
3 years in a supervisory / leadership role.
Leadership experience in a cGMP environment is required.
Aseptic processing experience is required.
Experience in commercial manufacturing required.
Working knowledge of cGMP Quality Systems (change management, discrepancy management, and validation).
Preferred experience in cell and / or gene therapy operations and contract manufacturing.
Skills and Ability
Frequent in-person onsite at CMO in Memphis, TN.
Ability to aseptically gown and navigate cleanroom manufacturing areas.
Strong analytical and problem-solving skills, strong attention to details
Excellent written and verbal communication skills.
Ability to work independently and as part of a team.
Demonstrated ability to partner and build trust, cultivating positive working relationships as Person-in-Plant at the CMO(s).
Effectively communicate changes and resolve issues with CMOs.
Lead and / or participate in cross functional manufacturing projects to ensure company objectives.
Up to 10% travel, domestic
Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.
Company Profile :
Founded by industry leaders to set a new standard in search, career placement and flexible staffing, we deliver coordinated staffing solutions with unparalleled service, a commitment to project completion and success and a passion for innovation, creativity and continuous improvement.
Our niche brands offer a complete suite of staffing services to emerging growth companies and the Fortune 500 across market sectors, career specialties / disciplines and industries.
Over time, office locations, specialty practice areas and service offerings will be added to address ever changing constituent needs.