Associate Principal Scientist/Associate Director, Engineering

Job Description

Our Downstream Purification department is seeking a passionate and skilled individual to lead the charge in transforming our late-stage pipeline and commercial products into reality. 

As a key player in our BDSC team, you will: 

• Lead and Collaborate: Participate in and/or spearhead cross-divisional technical teams focused on late-stage clinical process development, characterization, and technology transfer of biopharmaceutical drug substance processes. Your insights will be crucial for establishing an integrated control strategy suitable for commercialization and licensure for the products in our expanding late-stage biologics portfolio. 

• Drive Innovation: Conduct laboratory-scale and manufacturing-scale studies to support commercial process validation and characterization. You’ll design experiments, analyze data, and mentor junior staff, ensuring excellence in execution. 

• Enhance Process Understanding: Provide technical leadership in interpreting trends from commercial process monitoring, driving further investigations and process improvements that elevate our standards. 

• Engage Across Functions: Actively interact with internal and external partners, representing your functional area on cross-functional teams to foster collaboration and innovation. 

• Document Excellence: Author regulatory and technical documentation, ensuring all processes align with our company expectations. 

• Mentor Future Leaders: If you have a knack for leadership, you will also manage a small team of junior staff, guiding them in their professional development. 

Minimum Education Requirement and Experience: 

• Bachelor of Science (BS) degree in Biological Sciences, Chemical Engineering, Biological Engineering, or Chemistry with ten (10) years of relevant experience; OR

• Master of Science (MS) degree in Biological Sciences, Chemical Engineering, Biological Engineering, or Chemistry with eight (8) years of relevant experience; OR

• PhD in Biological Sciences, Chemical Engineering, Biological Engineering, or Chemistry with four (4) years of relevant experience. 

Required Skills and Experience: 

• Technical Expertise: Proficient in the purification of biological molecules, including chromatography and filtration systems. 

• Technology Transfer Experience: Proven track record in tech transfer or scaling up processes for biologics manufacture. 

• Communication Skills: Exceptional oral and written communication abilities to articulate complex concepts in a multi-disciplinary team environment. 

• Leadership Experience: Experience leading teams and fostering career development for junior staff. 

Preferred Skills and Experience: 

• In-depth knowledge of harvest, preparative chromatography, and filtration techniques. 

• Experience in pilot or commercial scale manufacturing of biological molecules. 

• Familiarity with late-stage process development, process characterization, process validation regulatory submissions, and working with external contract organizations. 

• Proficiency in statistical methods for design of experiments (DOE) and data analysis, as well as statistical process control (SPC) and multivariate analysis (MVA). 

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

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As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, ag