MSAT Specialist II
Company: AGC Biologics
Location: Boulder
Posted on: May 12, 2022
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Job Description:
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. 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.
Summary
The MSAT Specialist II 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.
Principal Responsibilties
Participate as an MSAT representative on client project teams.
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
introductions.
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
verification reports.
Prepare and present data associated with manufacturing processes to
internal and external clients.
Support for process validation preparation, execution, and
reporting.
Maintenance of Process Control Strategy.
Work with clients on process mapping and scale-up of manufacturing
processes.
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,
etc.).
Proven experience successfully managing multiple projects
simultaneously.
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
manufacturing operations.
Strong communication skills necessary to interact with internal
stakeholders.
Strong presentation skills.
Expertise in relevant math, science and engineering
disciplines.
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.
Large scale stainless steel experience will be preferred
Education/Experience
BS in Biochemistry, Chemistry, Biology or other relevant discipline
required; MS in related discipline preferred
2 or more years' relevant experience from the pharmaceutical
industry working in a cGMP environment.
Advantage with relevant experience bringing biotechnology equipment
and processes from design through GMP operational readiness.
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
documentation.
Advanced computer skills including Excel and Word.
Compensation Range
$78,083 - $93,700
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
ordinances
Keywords: AGC Biologics, Boulder , MSAT Specialist II, Other , Boulder, Colorado
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