Biopharmaceutical Manufacturing Manager

Industry

Pharmaceuticals

Advert ID

FOX_BBBH175193

Location

Rochester

Job Type

Permanent

Hours

Full-Time

Salary Range

Based on Experience

No. of Openings

1

Branch Information

Minnesota Engineering - (USA) 3600 Minnesota Drive Suite 850 MN Edina , MN 55435

ContactNumber

612-630-1200

Job Description

Manpower Engineering is working with a cutting-edge biotechnology company with a mission to develop clinically impactful and accessible therapies using innovative regenerative medicine technologies based on cellular science. The company's ultimate mission is to deliver cutting edge solutions accessible to any patient in need, anywhere in the world.



The company is currently hiring for a Biopharmaceutical Manufacturing Manager who will support process development and implementation for a high-tech biopharmaceutical manufacturing facility. This is a hands-on role supporting both current and future development and manufacturing of biopharma products.



Job Responsibilities:





* Manage team projects to achieve department and corporate goals, including managing timelines and leading group meetings.

* Manage scheduling in coordination with cross-functional groups. Drive resource planning such as materials, personnel, and equipment to ensure seamless operation of manufacturing activities.

* Act as point person for inventory management and escalating supply chain issues related to personnel, safety, procedures, materials, process, equipment, automation, utilities, and/or information systems to appropriate functional area(s).

* Utilize data monitoring and analytics to evaluate past performance and trends and forecast inventory and distribution requirements.

* Routinely participate in new procedure planning and implementation into the supply chain and manufacturing areas.

* Lead receiving unit component of technology transfer and final process development for the Manufacturing team. This includes transfer of method, materials, facility requirements and documentation.

* Create, revise, and review controlled documents including Standard Operating Procedures (SOPs) and Batch Records for manufacturing.

* Lead, investigate, and collaborate with cross-functional stakeholders regarding quality systems, including quality events, deviations, CAPAs, change controls, and risk assessments.

* Write and review documents including necessary FDA compliant work instructions/batch records/forms/SOPs

* Escalate production floor issues related to personnel, safety, procedures, materials, process, equipment, automation, utilities, and/or information systems to appropriate functional area(s).

* Troubleshoot mechanical issues that arise with manufacturing equipment. Receive and manage equipment alarms.

* Support process and new product development activities and transfer to the manufacturing area.

* Work with scientists to plan and execute experiments and collect accurate data.

* Identify opportunities to improve process efficiency and the best plan of action for implementation.



Qualifications:





* Bachelor's degree in a science or engineering discipline or equivalent level of proven technical experience.

* Minimum five (5) years of experience in a process related science, including a pharmaceutical GMP manufacturing environment.

* Detail oriented and self-motivated with strong written and verbal communication skills.

* Experience in inventory management and resolving supply chain issues preferred.

* Ability to work independently/autonomously, within prescribed guidelines, or as a team member.

* Experience leading quality systems, including quality events, deviations, CAPAs, change controls, and risk assessments.

* Skilled at interviewing, hiring, and developing direct reports.