Medexus Pharma, Inc.

(Associate) Scientist/Process Engineer – MSAT and Tech Transfer

Position Overview

The Scientist/Process Engineer MSAT and Tech Transfer will support late stage and commercial phase biologics and small molecules. This position supports technical and scientific aspects of all drug substance and drug product manufacturing. The Scientist/Process Engineer – MSAT and Tech Transfer role will report to the Director, Program Management and Operations.

Responsibilities

• Participate in development and execution of process control strategies for continuous process verification (CPV), design and execute process capability assessments
• Participate in/lead process and technology transfer
• Participate in person-in-plant (PIP) activities and act as a Medexus representative at contract organizations
• Support Quality Assurance with executed batch record review for UF/DF, formulation, and fill/finish for late stage and commercial programs
• Provide technical expertise and scientific support for manufacturing changes, deviations, CAPA, root cause analysis, troubleshooting; working collaboratively with QA, QC, Operations, consultants and CMO partners
• Provide technical expertise for process transfers to contract/partner manufacturing sites
• Maintain knowledge of emerging bioprocess technologies
• Contribute technical support for Batch Planning Forecast, Schedule, and logistics as needed
• Identify continuous process improvements
• Participate in CMO audits
• Participate in regulatory agency meetings and inspection
• When deemed safe, travel for this role is anticipated to be up to 20%

Experience Requirements

• 6+ years in Biotech/Pharma including deep expertise in biologics manufacturing including cell culture, purification, formulation and drug product fill
• Minimum 3 years’ experience in a cGMP manufacturing environment on the biologics manufacturing floor and/or as a PIP
• Solid working knowledge of FDA, EMA, and ICH guidelines as applied to late stage and commercial phase biologics
• Experience with regulatory agency inspections

Skill Requirements

• Flexibility, adaptability and ability to thrive in a fast-paced environment
• Expert knowledge of data analysis tools such as Excel and JMP
• Expert knowledge of biologics manufacturing including upstream and downstream drug substance manufacturing and lyophilization
• Strong verbal and written communication skills, responsiveness and a high level of attention to detail
• Strong analytical, problem-solving and critical thinking skills
• Proven ability to innovate
• Highly collaborative with outstanding relationship management skills

Education Requirements

• BA/BS/MS/PhD in a Biochemistry, Biology, Chemical Engineering, Bioengineering or Pharmaceutical Technology or related discipline

Medexus Pharma, Inc. is a fully integrated specialty pharmaceutical company based in Chicago, Illinois. Medexus has core capabilities in development, operations and commercialization and is focused on the development and commercialization of treatments for autoimmune diseases, oncology, and other near market opportunities with the potential to impact patients’ lives. By forming new partnerships and leveraging our business development efforts, we have the opportunity to make significant medical advancements that can help patients live better lives.

Medexus Pharma is committed to equal opportunity and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

All applicants must have authorization to work for Medexus Pharma in the United States.

Medexus Pharma, Inc.
Medexus Pharma, Inc.
29 N Wacker Drive
Chicago, IL 60606
Email: careers@medexus.com

Medexus Pharma, Inc. is an Equal Opportunity Employer

Submitted: 04/17/2021