Aseptic Control Principal Scientist, MSAT Full-time

Job Title

The incumbent will work cross-functionally with colleagues in the BSMO/CMSC, Regulatory, Quality and R&D of Vertex on the design of processes and technologies required to produce aseptic and/or low bioburden drug products to successfully commercialize an exciting and diverse portfolio of innovative pipeline programs. In addition, the successful candidate will support the implementation of risk-based design and controls for low bioburden process operations for production of drug substance/intermediates for manufacturing.

Key Duties And Responsibilities

Provide technical input into environmental/facility/process monitoring program deviations and contamination events to determine impact to batch disposition and design/implement effective corrective and preventative actions to prevent future disruptions.

Strong collaboration in the resolution of manufacturing investigations related to aseptic control events

Support the design and implementation of risk-based approaches and strategies designed to control bioburden and prevent contaminations for drug substance and drug product manufacturing sites.

Support of regulatory submissions and pre-approval inspection activities related to contamination control and prevention and control strategies for aseptic operations.

Work closely with colleagues in Process development to design and implement new technologies for aseptic filling of cell therapy drug products in novel device platforms; this includes working closely with Contract Development and Manufacturing Organizations (CDMOs) and engineering firms to design processes and equipment needed to perform aseptic filling operations in a GMP environment.

Establish processes and capabilities to provide technical stewardship of control strategies post-approval including establishing performance monitoring capability and troubleshooting/ out of conformance event resolution. This will involve partnering closely with external contract manufacturing and testing organizations to establish processes to monitor test process performance and continuous improvement initiatives.

Adherence to the culture of quality and ensure that all activities and documentation comply with regulatory requirements. Understand and implement processes, controls, and methods that align with global Health Authority regulatory expectations. Drive operational excellence, flawless execution and continuous improvement.

Knowledge And Skills

Deep understanding of technical and operational aspects of late phase to commercial GMP aseptically processed drug substance and drug product manufacturing regulations and excellent written and verbal communication skills. Prior experience supporting drug product manufacturing activities across multiple modalities (e.g., sterile dosage form, devices, etc.) and design of sterility assurance and facility monitoring programs is desired.

Experience with root cause analysis and deviation management

A proven ability to work seamlessly across teams and develop excellent relationship and partnerships with peers is critical to success in this role.

Demonstrated understanding of the principles and applications associated with commercial manufacturing operations.

Strong understanding of the technical aspects of manufacturing, testing, and controls and regulations governing pharmaceutical operations

Strong knowledge of cGMP requirements

A strategic thinker with strong result-orientation and a sense of urgency to deliver quality results on time and in a highly ethical and professional manner

Excellent communication and interpersonal skills with the ability to build strong cross-functional relationships and communicate complex issues and concepts enterprise-wide

Excellent team player and be able to build and sustain organization respect and trust at all levels

Problem solver with a hands-on approach and ability to anticipate adverse scenarios and provide contingency plans to address them

Resilient and able to work well in a demanding, fast paced entrepreneurial environment

Sound judgment and business acumen with personal versatility and flexibility as business and team evolve Keeps current on professional knowledge, expertise and best practice; influential in the external environment in the area of aseptic processing and participates in industry consortia/ conferences relevant to the field.

Education And Experience

At least 10+ years of experience in an aseptic drug product technical role in process development and/or manufacturing for biologics and/or cell therapy products, and demonstrated ability to implement industry-recognized best practices and risk-based approaches for sterility assurance and contamination control and prevention.

Pay Range

$145,500 – $218,300

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

Flex Designation

Hybrid-Eligible Or On-Site Eligible

In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select 2. On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com