MSAT Sr. Engineer, Downstream
Company: AGC Biologics
Posted on: August 7, 2022
AGC Biologics is a leading global Contract Development and
Manufacturing Organization, with a deep commitment to improving
life quality by bringing new biopharmaceuticals to market. Because
of our dedication to building and empowering our internal teams,
AGC Biologics is an innovative leader in the industry with an
extensive network of cGMP facilities in the US, Europe and Asia. As
such, we deliver a deep expertise, dynamic solutions and
technologies, as well as customized services for the scale-up and
cGMP manufacturing of protein-based therapeutics and cell and gene
therapies. We forge exceptionally strong partnerships with our
clients, and we never lose sight of our pledge to deliver a
reliable and compliant drug substance supply, Right, On time. For
more information, visit www.agcbio.com
The MSAT Engineer, Senior is part of the team responsible for
Process Transfer, Process Validation and Operational Excellence
that support GMP cell culture manufacturing operations, Develops
new technologies/equipment, and implements new systems, process
improvements, equipment and procedures.
- Participate as MSAT representative on client project
- Lead activities to transfer processes to Manufacturing from
internal AGC Process Development at other sites or directly from
customers, including driving the drafting and revising
manufacturing batch records.
- Perform manufacturability assessments for new process
- Define and provide user requirements for process equipment
associated with multiple facilities for the manufacture of biologic
Bulk Drug Substance(s).
- Provide technical leadership to Manufacturing and other
departments associated with GMP operations.
- Serve as the process Subject Matter Expert and provide input
when troubleshooting processes on the manufacturing floor and
during post-operational investigations
- Participate in the project team meetings, decisions, and
creation of milestones representing MSAT.
- Serve as the key project designee responsible for identifying
new technologies set to improve manufacturing capabilities.
- Maintain and report process run summaries and continued process
- Prepare and present data associated with manufacturing
processes to internal and external clients.
- Support for process validation preparation, execution, and
- Maintenance of Process Control Strategy
- Work with clients on process mapping and scale-up of
- Mentor junior engineers/staff
- Other duties as assigned.
Knowledge, Skills & Abilities
- Must be self-motivated, organized and proactive.
- Demonstrated ability to interface/communicate extensively with
internal and external clients.
- Ability to coordinate multi-departmental tasks and deliverables
(interaction with Process Development, Engineering, QA, QC,
- Proven experience successfully managing multiple projects
- Demonstrated ability to build effective working relationships
across departments (QA, Process Development, Project Management and
Business Development) to support new processes and products.
- Demonstrated experience leading troubleshooting efforts.
- Ability to provide technical training to others on GMP
- Strong communication skills necessary to interact with internal
- Strong presentation skills.
- Expertise in relevant math, science and engineering
- Expertise in Cell Culture from thaw to API fill.
- Expertise in Disc-Stack centrifugation.
- Thorough knowledge of GMP regulations (ICH Q7A) as it applies
to job function.
- BS in Engineering, Biochemistry, Chemistry, Biology or other
relevant discipline required; MS in related discipline
- 8+ years' relevant experience from the pharmaceutical industry
working in a cGMP environment, specifically in Process
- Advantage with relevant experience bringing biotechnology
equipment and processes from design through GMP operational
- Must have experience with and demonstrated understanding of
Good Manufacturing Practices (GMP) and applicable regulations
(e.g., ICH Q7A, 21 CFR Part 211, etc.).
- Must have experience writing, reviewing and approving GMP
- Advanced computer skills including Excel and Word.
$112,584 - $135,100
AGC Biologics offers a highly competitive compensation package and
a friendly, collaborative culture that values personal initiative
and professional achievement. AGC Biologics is an equal opportunity
employer. All qualified applicants will receive consideration for
employment without regard to age, ancestry, color, family or
medical care leave, gender identity or expression, genetic
information, marital status, medical condition, national origin,
physical or mental disability, political affiliation, protected
veteran status, race, religion, sexual orientation, or any other
characteristic protected by applicable laws, regulations and
Keywords: AGC Biologics, Boulder , MSAT Sr. Engineer, Downstream, Engineering , Boulder, Colorado
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