Job Description
Job DescriptionJob Title: Senior Associate Scientist
Location: Cambridge, MA 02142
Duration:12 Months+
Pay Range: $45 - $50/hr. on w2
Job Summary:
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.
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.
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.
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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