Maximizing talent to make a difference
Career Opportunities at Medexus Pharma, Inc.
The spirit of entrepreneurship is encouraged throughout our organization. We believe that creativity, originality, and inventiveness are essential to our growth and development. At Medexus Pharma, Inc. ideas are valued and accomplishments are rewarded. We hire talented individuals with innovative ideas and contributions, and our collaborative culture ensures that every one of those individuals has the opportunity to grow professionally and personally and contribute at a high level.
We are looking for hard-working and committed individuals who want to take on new challenges and help us fulfill our promise to patients. If you enjoy working in a fast-paced, collaborative, and entrepreneurial environment and have a desire to make a difference, Medexus Pharma may be the ideal place for you.
SCIENTIST/PROCESS ENGINEER – MANUFACTURING SCIENCES AND TECHNOLOGY (MSAT) AND TECH TRANSFER
The Scientist/Process Engineer for MSAT and Tech Transfer will support late stage and commercial phase biologics and small molecules including technical and scientific aspects of drug substance and drug product manufacturing. Responsibilities include routine manufacturing support (batch record review and contract manufacturer oversight), providing technical expertise and scientific support for manufacturing changes, deviations, CAPA, and root cause analysis. The Scientist/Process Engineer will also develop and execute process control strategies for continuous process verification (CPV), design and execute process capability assessments; participate in process and technology transfer; act as person-in-plant (PIP) and as a Medexus representative at contract manufacturers inside and outside the US (when travel is deemed safe). The Scientist/Process Engineer – MSAT and Tech Transfer will report to the Director, Program Management and Operations.
The successful candidate will have a Bachelor’s and/or a graduate degree in Biochemistry, Biology, Chemical Engineering, Bioengineering, Pharmaceutical Technology or related discipline. Six or more years in Biotech/Pharma with expertise in biologics manufacturing including cell culture, purification, formulation and drug product fill is necessary for this role. A minimum of three years’ experience in a cGMP manufacturing environment on the biologics manufacturing floor and/or as a PIP is required. Strong working knowledge of FDA, EMA, and ICH guidelines as applied to late stage and commercial phase biologics and experience with regulatory agency inspections is preferred.