BioPhase Solutions specializes in recruiting top talented professionals for San Diego's Scientific community. We are currently looking for a Manager, Downstream Biologics to work for a leading San Diego biotechnology company.
Manager, Downstream Biologics
The successful candidate will oversee and schedule purification operations and personnel within cGMP guidelines. He/She may supervise/perform operations within a class 100 area and/or sterile suite. Responsibilities will include managing and facilitating project meetings, interactions and communications. He/She will also identify and bring to resolution issues impacting purification projects, troubleshoot complex manufacturing process problems, and lead the purification team to identify issues and propose adequate solutions. While managing Biologics Manufacturing Purification productions, the Downstream Biologics Manager will ensure that all projects are executed properly, attaining desired outcomes on schedule and meeting quality standards. He/She will interact and communicate with clients regarding production. Additionally, the Downstream Biologics Manager will coordinate with multiple departments including sales and quality on production deliverables. The successful candidate will ensure that employees performing purification operations have obtained proper training on purification methods, cGMP guidelines, and SOP's. He/She will be responsible for training manufacturing personnel on the use of the Batchmaster ERP system for scheduling, ordering of raw materials, setting up production batches, and maintaining buffer inventory. The successful candidate will be responsible for writing/reviewing purification batch records, reviewing SOP's pertaining to purification processes and equipment, writing/reviewing User Requirement Specifications (URSs) in preparation for the ordering and receiving of equipment to be used in the purification process. He/she will analyze data and results and provide conclusions and proposals. May operate production equipment and prepare buffers and media, inspect, label, or box. The Downstream Biologics Manager will work with Manufacturing, Regulatory and Quality, Engineering and Technology groups on issues and identifies process improvement opportunities. Additionally, he/she will be responsible for establishing performance standards, employee coaching and development, determining employee responsibilities, evaluating performance and rewarding as appropriate, disciplining and recommending termination when necessary. He/she will identify, recruit, and retain top-notch talent.
The qualified candidate will have a Bachelors of Science degree or advanced degree in a Life Sciences discipline or equivalent, for example: MS + 7 years or BS + 10 years relevant experience in manufacturing or laboratory experience, including process development, optimization, scale-up, cGMP and supervisory experience. The Downstream Biologics Manager will demonstrate the ability to operate with a significant degree of independence in conducting manufacturing activities. The qualified candidate will be detail oriented with strong written and verbal communication skills.
He/she must have the ability to work independently, within prescribed guidelines, or as a team member, and the demonstrated ability to follow detailed directions in laboratory environment.
Familiarity with Microsoft Office applications is a must.