Associate Principal Scientist, Biologics Drug Substance Commercialization; Associate Director

Position: Associate Principal Scientist, Biologics Drug Substance Commercialization (Associate Director)
** Job Description
** The Associate Principal Scientist (Associate Director) provides technical and scientific leadership to advance late-stage and commercial biologics from development into reliable manufacturing. This role is responsible for designing, scaling, and transferring purification processes that ensure biological drug substances are produced safely, consistently, and in compliance with regulatory requirements. By partnering closely with process development, manufacturing, quality, and regulatory teams, the Associate Principal Scientist helps establish robust control strategies that support product licensure and long-term commercial success.
** Responsibilities
* ** 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.
* Conduct laboratory-scale and manufacturing-scale studies to support commercial process validation and characterization.
* Design experiments, analyze data, and mentor junior staff, ensuring excellence in execution.
* Provide technical leadership in interpreting trends from commercial process monitoring, driving further investigations and process improvements.
* Actively interact with internal and external partners, representing your functional area on cross-functional teams to foster collaboration and innovation.
* Author regulatory and technical documentation, ensuring all processes align with our company’s expectations.
* Manage a small team of junior staff, guiding them in their professional development.
** Qualifications
* ** Required
* * A degree in Biological Sciences, Chemical Engineering, Biological Engineering, or Chemistry with relevant experience:
Ten (10) years of required experience with a bachelor's degree, Eight (8) years with a master's degree, and Four (4) years with a PhD.
* Proficient in the purification of biological molecules, including chromatography and filtration systems.
* Proven track record in tech transfer or scaling up processes for biologics manufacture.
* Exceptional oral and written communication abilities to articulate complex concepts in a multi-disciplinary team environment.
* Experience leading teams and fostering career development for junior staff.
* Preferred
* * 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).
*
* Required Skills:

** Adaptability, Adaptability, Biochemical Analysis, Biological Engineering, Biomedical Engineering, Bioprocessing, Chemical Engineering, Chromatographic Analysis, Chromatographic Techniques, Chromatography, Clinical Process, Cross-Functional Collaboration, Data Analysis, Decision Making, Detail-Oriented, Downstream Operations, Downstream Processing, Foster Innovation, Leadership, Maintenance Supervision, Manufacturing Process Validation, Manufacturing Quality Control, Manufacturing Scale-Up, Mentorship, Process Improvements {+ 7 more}
** Preferred

Skills:

** Current Employees apply

Current Contingent Workers apply
** US and Puerto Rico Residents Only:
** Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please  if you need an accommodation during the application or hiring process.

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, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with…