Principal Associate Scientist, Analytical Sciences

Alnylam Pharmaceuticals; Cambridge (MA); On-site; USD 111,000 - 138,000; Full time

Job summary

Alnylam Pharmaceuticals in Cambridge, MA seeks a Principal Associate Scientist (Multiple Positions) to perform analytical testing of siRNA drug substances, drug products, and critical raw materials. You will author stability protocols, reports, and SOPs, and contribute to design and execution of stability studies using DoE principles.

The role requires a Master’s or Bachelor’s with extensive experience in analytical chemistry, cGMP, and regulatory documentation.

Qualifications

• Experience with analytical instruments and techniques (HPLC, UPLC, UV/Vis) and pH
• Experience in analytical data review, interpretation and trending
• Experience with statistical analysis of data
• Experience in investigations, deviations and change controls
• Experience with stability studies under ICH guidelines
• Strong technical writing abilities
• Experience in analytical laboratory CGMP environment

Responsibilities

• Perform analytical testing of drug substances and products
• Author and review stability protocols, reports and SOPs
• Contribute to DoE-based stability studies (freeze-thaw, thermal cycling, device compatibility)
• Support GMP/GxP stability programs and data interpretation
• Assist with regulatory submissions sections and agency responses

Skills

Analytical testing

Stability studies

Statistical analysis

cGMP laboratory environment

Data review & interpretation

Method development & validation

HPLC

Education

Master's degree in Engineering/Analytics/Chemistry/Pharmacy/Biochemistry or related field

Bachelor's degree in Engineering/Analytics/Chemistry/Pharmacy/Biochemistry or related field

Tools

HPLC

UPLC

UV/Vis spectroscopy

pH meter

Job description

NOTICE OF FILING AN APPLICATION FOR PERMANENT EMPLOYMENT CERTIFICATION

JOB TITLE:

Principal Associate Scientist (Multiple Positions)

JOB DUTIES:

Perform analytical testing of siRNA drug substances, drug products, and critical raw materials. Author and review stability protocols, reports, and SOPs. Contribute to the design and execute special use stability using sound DoE principles. Studies include freeze-thaw, thermal cycling, compatibility with intended injection device, and in-use studies. Support outsourced GMP/GxP stability programs for drug substance and drug product. Provide sound statistical interpretation of stability data, and their relation to release and lifetime specifications. Contribute data to characterization, analytical, and stability sections of regulatory submissions. Assist with responses to agency requests on these sections. Contribute to investigations of stability Out of Trend (OOT) results. Contribute as owner of Change Controls and CAPA. Provide stability expertise to the assessment of temperature excursions.

MINIMUM EDUCATION AND EXPERIENCE REQUIREMENTS:

Master's degree in Engineering (any), Analytics (any), Chemistry, Pharmacy or Biochemistry or related field of study and four (4) years of experience in the job offered or related occupation in which the required experience was gained. In lieu of a Master's degree in Engineering (any), Analytics (any), Chemistry, Pharmacy or Biochemistry or related field of study and four (4) years of experience, the employer will also accept a Bachelor's degree in Engineering (any), Analytics (any), Chemistry, Pharmacy or Biochemistry or related field of study and seven (7) years of experience in the job offered or related occupation in which the required experience was gained. Must have demonstrated experience with: Analytical Instruments and Techniques (HPLC, UPLC, US spectroscopy or pH); analytical data review, interpretations, and trending; statistical analysis of data and interpretations; Investigations, Deviations and Change Controls; stability studies designed and conducted in accordance with ICH stability guidelines; technical writing; and analytical laboratory environment (cGMP).

OTHER:

Employer: Alnylam US, Inc.

Job location: 675 W Kendall Street, Cambridge, MA 02142

40 hours/week; $110,550.00 - $138,000.00/Year (view contact information below)

If offered employment must have legal right to work in U.S. EOE.

This notice is being posted as a result of the filing for a permanent resident labor certification application for this job opportunity. Any person may provide documentary evidence bearing on the application to:

U.S. Department of Labor

Employment and Training Administration

Office of Foreign Labor Certification

200 Constitution Avenue NW, Room N-5311

Washington, DC 20210