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.
QUALITY CONTROL MANAGER
The Quality Control Manager will oversee all analytical work occurring at contract organizations including analytical development, in-process analysis, bioassays, and release testing for drug substance and drug product. They will ensure that analytical methods are developed and qualified/validated per cGMP and that all QC activities are conducted in accordance with global regulatory requirements to ensure ongoing supply of product to meet clinical and commercial demand. The QC Manager will lead comparability, stability and method performance trending programs.
The qualified candidate will have a PhD in biology, biochemistry, biopharmaceutical sciences or other biological science related discipline and 7+ years progressive cGMP quality, testing, scientific, and/or manufacturing experience in pharmaceuticals including biologics. Expertise in chemical, protein and bioassay including experience on the bench is required. Experience with recombinant form of human factor IX or similar commercial biologics is desired.