Analytical Science and Technology Senior Scientist for Commercial Manufacturing & Supply Chain (Contract)
Analytical Science and Technology Senior Scientist for Commercial Manufacturing & Supply Chain (Contract)
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
Job Description
Job Summary:
The Senior Scientist (contractor) will be part of Analytical Science and Technology (ASAT) team within Commercial Manufacturing & Supply Chain (CMSC) department. S/He/They will provide support with development and execution of the analytical CMC strategy by contributing to team goals maintaining source data and delivering high-quality technical documentation for late-stage and commercial Cell and Gene Therapy and Biologics programs.
This is a Hybrid/Remote role.
This is a contract role
Key Responsibilities:
- Support preparation of global regulatory submission sections for late-stage and commercial programs in analytical CMC areas (e.g. registrational CQAs control strategy justification of specifications and comparability studies)
- Author and/or review technical documents such as justification of specifications method bridging forced degradation characterization comparability and stability reports.
- Assist with QMS activities (Change Control Impact Assessment Change Action Owner) related to CMC implementation.
- Perform data verification trending and statistical analysis to support regulatory strategy and product characterization.
- Collaborate cross-functionally with internal stakeholders and external partners to support analytical readiness for commercialization and ongoing product lifecycle activities.
Knowledge and Skills:
- Strong technical writing skills are essential; regulatory writing experience (e.g. eCTD Module 3 sections and/or responding to health authority responses) is highly desirable.
- Experience in analytical CMC development for cell and gene therapy (CGT) or biologics particularly from late-stage development through commercialization.
- Prior experience working with contract testing organizations (CTOs) or manufacturing sites (CDMOs) is a plus.
- Familiarity with GMP USP/ICH and regulatory guidance applicable to analytical methods and commercial-stage CMC.
- Strong understanding of analytical support for commercial biological products and cGMP manufacturing.
- Proven ability to manage multiple priorities meet timelines and maintain flexibility in a fast-paced environment.
- Effective collaboration communication and multitasking skills.
- Familiarity with commercial program lifecycle QMS systems and regulatory submission expectations is preferred.
- Proficiency in statistical analysis tools (e.g. JMP GraphPad Prism) is required.
Education and Experience:
M.S. (or equivalent degree) in biochemistry chemical engineering or a relevant scientific discipline and 6 years of experience in the biopharmaceutical industry or B.S. (or equivalent degree) in biochemistry chemical engineering or a relevant scientific discipline and 9 years of experience in the biopharmaceutical industry
Pay Range
$65-$75/HR
Requisition Disclaimer
This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (Vertex). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation medical benefits fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors including skills competencies experience location and/or being pursued and other job-related factors permitted by law. In addition this role will be eligible for overtime pay in accordance with federal and state requirements
By applying for this position you agree to the Atrium Terms and Conditions and you direct Atrium to share your application materials which may include your CV/Resume email address or phone number with Vertex. For more information on how Vertex handles your personal data related to your job application please see Vertexs Careers Privacy Notice. Agreeing to the Atrium Terms and Conditions includes permission to use the email address and mobile phone number you provide during the application process or throughout the duration of your prospective or actual employment to notify you of job openings profiles articles news and other employment-related information as well as to notify you of special promotions or additional products and services offered by us or our affiliates and partners
(collectively Atrium Alerts). Atrium Alerts may be sent by email phone or text message. Your personal information will be safely stored within the Atrium & Vertex databases. Atrium does not sell your personal information to third parties. Text message and data rates may apply. To OPT OUT of text messaging or to modify your communication preferences for Atrium Alerts at any time please contact Atrium at .
If you do not agree with the Atrium Terms and Conditions you can still complete your application for this position by emailing your resume to our team at Please include the job title in the subject of your email.
No C2C or Third-Party Vendors
Required Experience:
Senior IC
Employment Type
Unclear
