46 applicants
Randstad Life Sciences US ยท 6 hours ago
Senior Scientist
North Billerica, MA
Full-time
Hybrid
Senior Level
4+ years exp
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Hiring Manager
Charulatha Vedhachalam-Felse
Insider Connection @Randstad Life Sciences US
Responsibilities
Work with minimal supervision to achieve personal objectives, while constantly realigning to meet evolving organizational needs.
Participates with cross functional teams in the development and maintenance of long and short-term requirements with CMOs for external API, raw materials, and critical packaging components.
Summarize data or situational information in memos or reports, for the purpose of position statements.
Participate in e-mail and/or verbal discussion to determine requirements and negotiate a solution.
Review updates to master batch records, document the changes, and align with API Technology Liaison on how to justify the changes; initiate and own the associated change control.
Lead cross-functional teams of MT&D, QC, QA and Supply Chain (SC) representatives to: (1) manage process changes through Quality Management System (QMS) for cGMP compliant manufacturing at CMOs; (2) resolve manufacturing issues; and (3) implement continuous improvements in internal GMP systems.
Support the collaboration of R&D and Technical Development resources with the CMOs to develop, transfer, and validate commercial scale API and raw materials manufacturing processes for pipeline products.
Compile, analyze and report data from multiple sources: executed batch record, lab notebook and/or reports.
Create chemistry process descriptions, and make comparisons between versions of the processes.
Review non-GMP and GMP batch records, ensuring the process adhere to the standard process.
Assist supplier qualification projects for APIs, excipients, raw materials, and reference standards by proving light project management and/or serving as the technical lead.
Maintain meeting minutes and/or project status, where appropriate
Build and/or maintain knowledge bases for various categories of materials, such as reference standards, excipients, API.
Actively demonstrates the values of Letting people be their best, Respect one another and act as one; Learn, adapt, and win; Know someone's health is in our hands; and Own the solution and make it happen.
Qualification
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Required
Minimal B.S. in organic chemistry, process chemistry, chemical engineering, Pharmaceutics or similar technical area.
4+ years experience within a regulated GMP/GLP environment in the areas of manufacturing process development, process validation, technical transfer, analytical support, quality assurance, technical operations, or manufacturing.
This position requires flexibility with changing priorities.
Excellent external and internal communication skills required
Excellent written and verbal communication skills required
Solid organizational skills including attention to detail and multitasking skills required
Strong working knowledge of Microsoft Office, required
Preferred
Experience with project management software tools, such as MS Project, is preferred
Minimal travel may be required.
Company
Randstad Life Sciences US
Randstad North America, Inc. is a wholly-owned subsidiary of Randstad N.V., the world's largest HR services provider.
Deerfield, IL
1,001-5,000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase
