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Process & Manufacturing Engineering @MMK Senior Biopharmaceutical Engineer (Drug Substance & Drug Product)
A number of our client companies are seeking to hire Senior Engineers to join drug substance and sterile fill finish manufacturing teams.
In this pivotal role, you'll drive the strategic development and manufacturing of life-changing therapies, contributing significantly to both drug substance and drug product aspects of the biopharmaceutical pipeline.
We need a leader who's passionate about pushing the boundaries of bioprocess engineering, thrives on solving complex challenges, and is ready to make a substantial impact in a fast-paced and innovative environment.
Key Responsibilities: Lead the design, development, and optimization of cutting-edge upstream and/or downstream processes for biologics manufacturing (e.g., cell culture, fermentation, purification, viral inactivation).
Oversee the development and optimization of robust drug product formulations and manufacturing processes (e.g., fill/finish, lyophilization, sterile manufacturing).
Drive process characterization, scale-up, and technology transfer initiatives, ensuring successful implementation and commercial readiness.
Provide expert guidance in troubleshooting complex manufacturing issues, implementing sustainable and compliant solutions.
Ensure rigorous compliance with cGMP regulations, industry best practices, and lead efforts in regulatory interactions.
Strategically collaborate with cross-functional leadership teams across R&D, Quality, Manufacturing, and Regulatory Affairs to advance pipeline programs.
Mentor and develop junior and mid-level engineers, fostering a culture of technical excellence, innovation, and continuous improvement.
Present complex technical data and strategic insights to senior leadership and external partners.
Qualifications: Bachelor's, Master's, or Ph.D. in Process & Chemical Engineering, Electrical Engineering, Mechanical Engineering or a related discipline.
Extensive experience (typically 10+ years) in the biopharmaceutical industry, with a proven track record of leadership in either drug substance (upstream/downstream) or drug product development and manufacturing.
Parenteral experience is highly desirable.
Deep expertise in biologics manufacturing principles, advanced unit operations, and sophisticated process control strategies.
Comprehensive understanding and experience with cGMP environments and advanced quality systems.
Demonstrated ability to strategically resolve highly complex technical and operational challenges.
Exceptional leadership, communication, and interpersonal skills, with a proven ability to influence and collaborate across all levels of an organization.
Strong analytical acumen and a track record of innovative problem-solving.
Preferred Qualifications: Proven expertise with single-use technologies.
Significant experience with regulatory submissions.
If you are a visionary and highly experienced Biopharmaceutical Engineer ready to lead critical initiatives, we invite you to apply.
Seniority level Seniority level Mid-Senior level Employment type Employment type Full-time Job function Job function Engineering and Science Industries Manufacturing Referrals increase your chances of interviewing at Morgan McKinley by 2x
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