BIOMANUFACTURING SCIENTIST (BMO-005)

General Job Description/Team Overview:

As part of a talented and highly motivated multi-disciplinary team advancing an exciting new approach to drug discovery, development, and manufacturing, the successful candidate will be part of a skilled Manufacturing team working to execute GMP production campaigns in close collaboration with the Process Development Team to supply the company’s clinical pipeline targets. Responsibilities for this position include on-the-floor operations in Cell Culture, Purification, and Aseptic Fill/Finish. Additionally, this role will perform manufacturing support activities including deviation writing, change control, technology transfers, inventory control, and other assigned activities. The level will be determined based upon the candidate’s education, skills, and/or related experience. 

Primary Duties and Responsibilities (include but are not limited to):

· Perform Cell Culture (Seed Train Expansion and Maintenance, Wave/Rocker Bioreactor Systems, and Single-Use Bioreactor Systems), Purification (Chromatography, Filtration), Buffer and Media preparation, Formulation, and Aseptic Fill/Finish, while adhering to all cGMP and GDP standards.

· Effectively engage cross-functionally with other departments to troubleshoot and continuously improve all operations supporting cGMP manufacturing instruments, equipment, and processes.

· Generate, review and/or revise batch production records, logbooks, and technically sound Standard Operating Procedures (SOPs) to support manufacturing operations.

· Maintain and sustain all organizational training profile requirements with strict adherence to safety and compliance.

· Own and/or actively participate in deviation investigations, change controls, and CAPAs.

· Engage with external vendors and internal stakeholders to procure and manage equipment and inventory levels.

· Assist and cross-train with Process Development to improve process knowledge. 

  · Technology transfer of process from lab-scale to GMP-scale in support of creating material for early-stage clinical demand.

· Identify, recommend, and implement process improvement initiatives. 

· Ensure high-quality and timely completion of assignments and projects.

· Perform other duties as assigned.

Required Qualifications:

· Bachelor’s Degree or higher (STEM field preferred). 

· Experience in cGMP operations working with manufacturing equipment. Years of experience will determine the hiring level. 

· High degree of self-motivation and the ability to take initiative and work under pressure and against tight timelines.

· Ability to take direction well, follow documents and policies at all times.

· Ability to lift 30 lbs.

· Proficient in computer skills including Microsoft Office (Word, Excel, PowerPoint) and others as applicable.

· Excellent organizational skills with attention to detail and accurate record keeping.

· General knowledge of Federal and State regulatory requirements in a GxP environment.

· High degree of discretion dealing with confidential information.

· Ability and willingness to work flexible hours when needed.

· Demonstrated ability to work independently and in a team environment.

· Excellent written, verbal, and, interpersonal communication skills

· Proficient in computer skills including Microsoft Office (Word, Excel, PowerPoint) and others as applicable.

· Excellent organization skills with attention to detail and accurate record keeping.

· General knowledge of Federal and State regulatory requirements in a GxP environment.

· High degree of discretion dealing with confidential information.

· Ability and willingness to work flexible hours when needed.

· Demonstrated ability to work independently and in a team environment.

· Excellent written, verbal, and interpersonal communication skills.

· Eligible to work in the U.S.

Compensation Range: $70,000-$90,000

Job Type: Full-time