Sr. Engineer II, Process Development

The Role:

Our team looks forward to welcoming an experienced Bioprocess Engineer with a strong background in the regulated (bio)pharmaceutical environment supporting laboratory, pilot and commercial scale process development, mRNA technology transfer to internal and external GMP production facilities and commercial production of mRNA therapies. Our team’s goal is to implement and support robust commercial manufacturing processes.  This Senior Engineer role requires close working relationships with Analytical Development, Manufacturing Sciences and Technology, Manufacturing, Supply Chain, Quality, Regulatory and Program Management functions as well as with external CMO teams.  The incumbent will also help develop industry skills in high-performing junior team members both at the bench and in GMP manufacturing facilities.

We are establishing commercial processes that require a solid practical foundation in standard bioprocess unit operations (e.g. UF/DF, normal flow filtration, mixing systems, chromatography). The ideal candidate should have a strong background of supporting commercial operation of these unit operations with a focus on pro-active process improvements and optimization, effective troubleshooting, interfacing with existing teams to collaboratively resolve process investigations and implement appropriate controls to ensure robust commercial manufacturing. These skills should be complemented with a track record of excellent written and oral communication skills and experience operating within a Quality Management System.   A history of process development and process investigation accomplishments using scaled down models, QbD-principles and process characterization/modeling techniques are strong pluses.

Success in this role would be demonstrated by effective participation in process investigations, design and performance of experiments to identify/confirm associated root causes, followed by characterization and implementation of effective process changes to increase success in commercial production. This position bears the potential for significant growth in a dynamic organization.

Here’s What You’ll Do:

• Provide subject matter expert (SME) expertise and representation in cross-functional process investigations for commercial processes.

• Support process investigations by active participation in root cause assessment exercises utilizing standard-industry tools

• Design and execute detailed experiments to assess and confirm root causes of process deviations and identify effective mitigation tools.

• Cross-functionally support establishment of appropriate CAPAs needed to improve robustness of commercial manufacturing processes.

• Identify opportunities for pro-active process improvements and optimization based on commercial performance data to improve robustness of commercial manufacturing process.

• Interface extensively in a matrixed environment with process development teams for process investigation support, assess new technologies, support on-going process characterization and post-approval changes.

• Support technology transfer and establishment of commercial process at new manufacturing sites and provide Person-in-plant (PiP) support as needed.

• Perform GMP activities with adherence to Quality Management System requirements.

• Mentor junior team members.  Supervisory role may be included.

• Communicate clearly with program stakeholders, technical staff and external CMO partners.

• Generate high quality source documentation to support regulatory filings.  

Here’s What You’ll Bring to the Table:

• BS with a minimum of 8 years, or MS with a minimum of 5 years, or Ph.D with a minimum of 2 years of industry experience in bioprocess development and/or manufacturing sciences.  Engineering-related degree preferred.

• Demonstrated background of providing technical support to commercial manufacturing processes, including but not limited to, support of process investigations, implementation of pro-active process modifications and support of post-approval changes

• Experience with mature quality management systems, deviation management, change controls and CAPA implementation

• Experience with lipid nanoparticle process development and mRNA process development is preferred.

• Experience in large molecule process development (late phase/commercial experience preferred)

• Knowledge of the large molecule regulatory environment, particularly FDA/ICH/ISPE guidelines on risk management, technology transfer and process validation.

• Strong operational skills, interdependent project/timeline management capabilities.

• Strong interpersonal skills with an eagerness to support colleagues across the orga