Senior Staff, Manufacturing Technical Operations Manager (Contract)

Job Description:

This senior-level staff member on the MTO is responsible for complete ownership of quality records including, but not limited to Deviations, CAPAs, Change Controls, Risk Assessments and Analytical and Quality Control Investigations supporting cell manufacturing at our Boston site. This includes all aspects of record ownership, triages, investigation, CAPA and change controls. The person in this role will drive cross-functional root cause analysis meetings and promote compliance best-practices to ensure timely and thorough completion. This includes all aspects of MTOs operational compliance support with emphasis on tracking and executing CGT initiatives, implementing MTO best practices and ensuring exceptional internal and external department collaboration and communication. This role will be pivotal for distributing and acting on metrics as well as supporting MTO intake and prioritization. This role is an on-site position based in our Boston location. This role requires a high-level of schedule flexibility to support our cell manufacturing clinical hours of operation and timelines.

KEY RESPONSIBILITIES:

• Triage manufacturing issues in real-time on manufacturing floor.
• Use root cause analysis tools to lead and write investigations quality events in the cell manufacturing, quality control, material operations and facility operations functional areas.
• Identify and collaborate with SMEs for triage, determine immediate actions and containment, document initial impact assessments.
• Collaborate with subject matter experts on investigations to determine root cause and propose appropriate corrective and preventive actions.
• Own, drive and manage CMC CAPAs and change controls from initiation, assessment and planning, execution, and closure.
• Own deviations, CAPA, Effectiveness Check (EC) and Risk Assessment records in electronic Quality Management System (eQMS). Ensure all timelines and due dates are achieved.
• Promote MTO and QA- aligned compliance best practices to further establish operational and quality event record center of excellence teams.
• Other duties and projects as assigned to meet departmental requirements and clinical timelines.

QUALIFICATIONS:

• 6+ years progressive experience in pharmaceutical development and manufacturing.
• BS in engineering, science or related discipline.
• Excellent planning and organizational skills, with the ability to balance production, development and continuous improvement needs.
• Experienced with technical writing and performing event investigations in a GMP-compliant environment.
• Experience gowning manufacturing floor in Grade B environments.

Contract Length: 12 month with the chance to extend

$55/hr.-$65/hr.

Sunday-Thursday, 12 - 8:30pm, Monday-Friday 12-8:30pm and Tuesday-Saturday 12-8:30pm

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 Vertex’s 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 [email protected].

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 [email protected]. Please include the job title in the subject of your email.

No C2C or Third-Party Vendors