Senior Associate Scientist, Specifications

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.

Accountabilities
•Meet 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 the companies core values.

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.
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)

Physical/Environmental Factors
•Must be able to adhere to all laboratory safety requirements
•Must be able to travel between the companies sites

Pay ranges between $42-48/hr based on experience