Website TalentBurst, Inc.
TalentBurst, Inc.
Company : TalentBurst, Inc.
Job Title: Senior Associate Scientist
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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