Lead Process Engineer, Biopharmaceutical Operations
1 week ago
Responsibilities:
The Lead Process Engineer will oversee processes and operations of moderate to high complexity.
This role involves evaluating, transferring, and implementing innovative processes within a GMP facility dedicated to biopharmaceutical drug substance manufacturing.
Responsibilities include the transfer of both internal products and external contract manufacturing business (CMB) of client products into a multi-product environment.
The individual will demonstrate expertise and initiative in applying innovative solutions to intricate challenges using cutting-edge technology.Provide scientific and technological support throughout process transfers, product launches, and initial supply phases.
Act as the technical liaison between large-scale manufacturing and clients within a cross-functional project team, ensuring compliance with GMP and regulatory standards.
This position requires providing direction, strategic input, technical leadership, and mentoring to junior team members, while also supporting troubleshooting, process transfers, and continuous improvement initiatives in a large-scale biopharmaceutical manufacturing setting.
Serve as the technical lead for large-scale manufacturing for assigned upstream and/or downstream processes of moderate complexity, including but not limited to cell culture medium preparation, cell thawing, inoculum expansion, seed stage bioreactors, production bioreactors, and primary harvest processes such as centrifugation and filtration, liquid chromatography, column packing, tangential flow, and normal flow filtration, bulk formulation, filling, and freezing.
The technical expert will identify and implement enhancements to at-scale manufacturing technology to drive positive changes in GMP operations.
Independently or collaboratively plan and execute supporting activities, acting as a subject matter expert (SME) in technical processes, working alongside cross-functional teams and external clients to meet project timelines and quality standards while identifying and mitigating risks.
Lead evaluations of process requirements and facility-fit assessments for medium to high complexity projects, ensuring that processes align with standard manufacturing practices, policies, and regulatory requirements within the large-scale GMP facility.
Author and maintain technical documentation for complex at-scale processes, including Process Descriptions, Bill of Materials, Campaign Performance Summaries, Engineering Run Reports, Engineering Test Protocols, Product/Process Impact Assessments, and technical sections of regulatory submissions.
Responsible for ongoing process monitoring and reporting for large-scale manufacturing, including the design and development of data repositories and visualizations to analyze and report on process data and trends.
Contribute to the design and planning of small-scale studies in collaboration with Process Sciences for transfer to or continuous improvement of at-scale manufacturing.
Qualifications:
The ideal candidate will possess the ability to independently plan, execute, and deliver results with occasional guidance from leadership.
Experience in cross-functional teams within a dynamic, high-pressure environment is essential.
Strong organizational and multitasking skills are required to thrive in a fast-paced setting.
Familiarity with biopharmaceutical manufacturing processes, project management, and technical writing is necessary.
Experience in upstream and/or downstream biopharmaceutical manufacturing is preferred.
Knowledge of aseptic processing, in-process analytics, buffer preparation, and storage for at-scale GMP manufacturing is crucial.
Proficiency in technical writing and regulatory submissions is essential.
To enhance the efficiency and integrity of routine GMP operations, candidates must demonstrate skills in:
Regulatory Filing
Project Management
Communication
Engineering
A solid understanding of fundamental engineering and mathematical concepts related to cell culture, fluid transfer, gas transfer, and mixing is required.
Candidates should possess excellent mechanical aptitude.Proficiency with MS Office Programs is necessary.
Strong communication skills and the ability to work effectively in both team settings and as an individual contributor are essential.
Flexibility to support a 24/7 GMP production environment is required.
This position may involve a hybrid remote/on-site working arrangement.
PHYSICAL REQUIREMENTS:
Candidates must be able to gown into a GMP facility, stand for extended periods, and lift up to 50 lbs.
EEO:
Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of - Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.
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