Clinical/Development - Senior Associate Scientist
TalentBurst, Inc.
Cambridge, MA
Location: Cambridge, MA
Duration: 12 Months
Job Description:
The Senior Associate Scientist, Specifications will be responsible for specification support of siRNA drug substances and drug products. This is an onsite position.
Summary of Key Responsibilities:
• Initiate and manage specification change controls in a GMP setting.
• Expected contributions to general operations including review of data and authorship/review of technical documentation. Provide technical support as needed.
• Author and review SOPs and protocols in accordance with company and regulatory guidelines.
• Contribute to data review, analytical and stability sections of regulatory submissions. Assist with responses to agency requests on these sections.
• Contribute to specification assessment of existing and new products.
• Provie support in maintaining platform program specification documents
Accountabilities
• Meet Client goals supporting studies and defining specifications for new molecules in development.
• On-time and compliant completion of review and verification of stability data to support clinical supply.
• Implementation of stability and release specifications for product registration.
• Adhere to Client core values.
Hiring Requirements
Knowledge/Experience/Skill:
• BS or MS in Chemistry, Biochemistry or related disciplines.
• Minimum of 2 years of previous experience in a cGMP analytical laboratory environment.
• Preferred previous experience with stability studies designed and conducted in accordance with ICH guidelines.
• Must be a team player and open to change.
• Must have excellent communication and speaking skills. Can prepare presentations and present.
• Preferred – experience with HPLC and physico-chemical test methods of oligonucleotides. Alternatively - experience with HPLC and physico-chemical test methods of oligosaccharides or proteins.
Scope
The Senior Associate Scientist Specifications will be responsible for specification support of developmental and clinical siRNA drug substances and drug products.
Physical/Environmental Factors
(Complete if appropriate for role)
• Must be able to adhere to all laboratory safety requirements
• Must be able to travel between Client sites
Competencies
• Ability to write clear technical documents and provide meaningful presentations.
• Ability to work independently and in compliance with company policies and regulatory guidelines.
• Excellent team skills, organization, and strong interpersonal communication skills (written and verbal)
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About the Company
TalentBurst, Inc.
For over 20 years, TalentBurst Inc. has been an award-winning provider of cutting-edge Workforce Management Solutions. With a strong commitment to staying ahead in the tech landscape, we pioneer innovative approaches to talent acquisition. Our expertise spans Life Sciences, and Healthcare Staffing, Banking, Financial, IT, and Engineering, as well as Global Employer of Record (EOR), Agent of Record (AOR), State, Local Government and Education (SLED), and IC validation/compliance services. Additionally, our division, TalentProcure, leads the industry with offerings such as High Hazard Payroll, Managed Services, and Vendor on Premise (VOP) solutions.
Due to our prioritization of excellent standards, we are Joint Commission Certified and are a certified Minority Business Enterprise (MBE) in the USA and Canada. Supporting over 130 Fortune 500 companies globally, we excel in navigating the landscape of talent acquisition. In a world of constant change, we embrace developing people-centric solutions that address the unique demands of our clients. Stay connected by visiting our website and following us on social media!