Sr. Engineer I/II, LNP Process Development
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location: Norwood, Massachusetts
job type: Permanent
salary: $130,000 - 140,000 per year
work hours: 7 to 3
Our team looks forward to welcoming an experienced Bioprocess Engineer with a strong background in the regulated (bio)pharmaceutical environment supporting laboratory/pilot scale process development and leading mRNA formulation process technology transfers to internal and external GMP manufacturing facilities (domestic and international). Our team's goal is to define and implement robust commercial-scale manufacturing processes. This Senior Engineer role requires close working relationships with Analytical, 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 novel processes that require a solid practical foundation in standard bioprocess unit operations ( e.g. batch and/or single-pass TFF, normal flow filtration, mixing systems, chromatography). These skills should be complemented with a track record of effective troubleshooting, excellent written and oral communication skills and experience operating within a Quality Management System. A history of process development accomplishments using QbD-principles and PAT with feedback control are strong pluses.
In this role, multi-day domestic and/or international travel (up to 20%) should be expected to support technology transfer activities, including Person-in-Plant (PiP) support for Engineering and GMP batches in US and EU.
Success in this role would be demonstrated by the implementation of robust scaled-up GMP processes and the delivery of released early- and late-phase bulk clinical supplies. This position bears the potential for significant growth in a dynamic organization. Here's What You'll Do:
- Develop robust, scalable and well-characterized processes for the formulation of mRNA in lipid nanoparticles.
- Manage and execute transfer of mRNA formulation processes from process development labs to internal and external (CMO) GMP facilities to ensure timely GMP manufacture of clinical supply materials.
- Serve as SME Person-in-Plant for CMO manufacturing and support process-related troubleshooting. Employ industry-standard root cause analysis methodologies, as needed.
- Perform GMP activities with adherence to Quality Management System requirements.
- Prioritize work across many process development and manufacturing initiatives.
- Mentor junior team members. Supervisory role may be included.
- Communicate clearly with program stakeholders, technical staff and external CMO partners.
- Ensure high quality source documentation is generated to support regulatory filings.
qualifications: Here's What You'll Bring to the Table:
- BS with a minimum of 8 years, or MS with a minimum of 5 years, of industry experience in bioprocess development and/or manufacturing sciences. Engineering-related degree preferred.
- Demonstrable evidence of transferring established processes to internal or external partners.
- Ability to effectively document and communicate results.
- Experience in large molecule process development (late phase-preferred).
- Knowledge of the large molecule regulatory environment, particularly FDA/ICH/ISPE guidelines on risk management, technology transfer and process validation.
- Experience in independent project management.
- Strong interpersonal skills with an eagerness to support colleagues across the organization and in partner organizations.
skills: Project Management, Quality control, SOP, FDA, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.