Associate Principal Scientist​/Associate Director, Engineering- Biologics Drug Substance Commerc

Position: Associate Principal Scientist/Associate Director, Engineering- Biologics Drug Substance Commerc[...]
** Job Description
** the Manufacturing Division, specifically within the Biologics Drug Substance Commercialization (BDSC) team. 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.
** What You'll Do:
** 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’s 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.
*
* What We’re Looking For:

**** Education**:
* A degree in Biological Sciences, Chemical Engineering, Biological Engineering, or Chemistry with relevant experience:
* 10 years with a bachelor's degree.
* 8 years with a master's degree.
* 4 years with a PhD.
** Required*
* ** Skills**:
* 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**:
* 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:

** Biological Engineering, Biologics, Biomedical Engineering, Bioprocessing, Chemical Engineering, Chromatography, Communication, Data Analysis, Decision Making, Detail-Oriented, Downstream Manufacturing, Maintenance Supervision, Manufacturing Process Validation, Mentorship, Process Characterization, Protein Purifications, Team Management, Technical Leadership, Technology Transfer, Written Communication
** 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…