Looking at Data, putting it into a table, presenting that data in a report or power point
Keeping tabs on CMO's and other projects, attend status meetings
Review batch records and change controls
Must Have:
4+ years of experience within GMP/GLP regardless of degree
Understands GMP
External Communication
Negotiating experience
Worked on and with cross-functional teams
Experience with API and raw materials, as that would be their subject matter
Nice to Have:
Experience communicating with CMO's
Has led cross-functional teams
Project Management and project management software
Job Summary
This position reports to Associate Director, API Technology Liaison, in the Manufacturing Technology and Development (MTD) department. This contractor position, based in Northern Billerica, is to provide wide-ranging technical support to MTD with extensive research and scientific expertise and experience.
Supports the Life Cycle Management (LCM) of Active Pharmaceutical Ingredients (APIs), excipients, and raw materials which are manufactured at external Contract Manufacturing Organizations (CMOs). Role also supports continuous improvement projects both internally and in conjunction with CMOs to improve efficiency, increase process robustness, maintain commercial performance metrics, and reduce cost.
The qualified candidate must be self-directed, be a great team player, and have excellent communication skills to be considered for this role. Preference given to those candidates who have experience in life sciences or FDA regulated cGMP industries. The candidate may have limited project management experience, and will be mentored by their manager, to accomplish: setting project goals; determine agendas; facilitate group decision making; other tasks, as required. A wide degree of creativity and latitude is required for success in the role.
Job 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 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.
Education & Qualifications
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
Experience with project management software tools, such as MS Project, is preferred