Senior Associate Scientist

Job Description

Job Summary:

• The Senior Associate Scientist, Specifications will be responsible for specification support of siRNA drug substances and drug products.

Duties and 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.

Education and Experience:

• 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.
• Preferred – experience with HPLC and physio-chemical test methods of Oligonucleotide Product.
• Alternatively – experience with HPLC and physio-chemical test methods of oligosaccharides or proteins.

Knowledge, Skills and Abilities:

• Must be a team player and open to change.
• Must have excellent communication and speaking skills.
• Can prepare presentations and present.
• 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 Demands/Environmental Factors:

• Must be able to adhere to all laboratory safety requirements.
• Must be able to travel between Client sites.