Senior Technical Specialist (Contract) 23841
Job Description:
The Manufacturing Science and Technology (MSAT) Small Molecule Drug Product (SM DP) team is responsible for managing small molecule drug product from new product launch through commercial production. This involves commercial process validations, technology transfers as well as being accountable for commercial production.Vertex manages its portfolio of products using both internal and external manufacturing options, meaning the position involves collaboration across different disciplines and organizations. The Senior Technical Specialist plays a key role driving deliverables in this fast paced, highly collaborative, environment.
Ideal candidate will have experience in GMP environment with Investigation, Change Control, and Deviations.
Key Duties and Responsibilities:
The responsibilities of this position may include, but are not limited to, the following:
- Provides support for managing CGMP business process flows for Change Controls, Deviations and CAPAs.
- Be the owner of one or more CGMP business process flows.
- Supports cross disciplinary teams to drive the execution of key launch/tech transfer activities and produce the required documentation (VMP, VSR, PPQ protocol, PPQ report, etc).
- Collaborating within MSAT, Supply Chain, and Quality to support routine commercial manufacturing and process qualification/improvement activities associated with maintaining a commercial product (e.g. new material qualification).
- Participate in Resolving complex commercial manufacturing issues and quality investigations.
- Provide support to the industry leading CPV programing by tracking/trending commercial production.
- Support MSAT SM DP team scope of work with external suppliers.
- May require travel to contract manufacturing plants to monitor process performance or to troubleshoot manufacturing issues in the plant.
Qualifications:
- BS with 2+ years of experience, or
- Familiarity of principles and practice of GMPs and associated CMC regulatory considerations in a pharmaceutical environment
- Effective written and verbal communication skills
- Ability to multitask to effectively manage multiple activities and projects
- Ability to collaborate with and communicate results to relevant stakeholders
- Willingness and ability to work in a fast-paced, highly matrixed environment
- Willingness and Ability to travel domestically and internationally (approximately 30%)
- Ability to travel both domestically and Internationally
Pay Range:
$55-$65/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
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