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sr. scientist.
north billerica , massachusetts
posted 3 days ago
job details
summary
$45 - $50 per hour
temp to perm
bachelor degree
category life, physical, and social science occupations
reference48362
job details
job summary:
As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. We supply prestigious life sciences and biopharma companies with job seekers like you to achieve their business goals. If you're looking for a position where you can serve as an asset to your company while making a difference in others' lives, we have the ideal position for you!
location: North Billerica, Massachusetts
job type: Temporary
salary: $45 - 50 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
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 the company's 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.
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 the company's 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 company 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.
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
Minimal travel may be required.
skills: Project Management, MS-WORD, MS-EXCEL, MS-Project, GLP (Good Laboratory Practice), GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
Applications accepted on ongoing basis until filled.