Process Engineering Manager
Semma Therapeutics
Job Description
General Summary:
The Technical Operations Drug Product 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.
Key Duties and Responsibilities:
- Work with 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)
- Leading collaborations with commercial manufacturing and quality to support ongoing qualification activities associated with maintaining a commercial product (e.g. new material qualification)
- Be an owner of a commercial product(s) and be accountable for Change Controls, Deviations and CAPAs
- Resolve complex commercial manufacturing issues and lead quality investigations to their resolution
- Drive the industry leading CPV programing by tracking/trending commercial production
- Support Tech Ops Drug Product team scope of work with internal and external suppliers
- Assists in maintaining effective relationships between Vertex and key suppliers of materials, technology, and manufacturing resources
- Will require travel periodically to contract manufacturing plants to monitor process performance or to troubleshoot manufacturing issues in the plant
Education and Experience:
- BS with 4+ years of experience, or
- MS with 2+ years of experience, or
- PhD with 1+ years of experience
- Knowledge of cGMP’s, associated CMC quality systems and regulatory considerations in a pharmaceutical setting
- Experience managing projects in the pharmaceutical industry
- Fundamental understanding and application of technology transfer and validation processes
- Solid communication, collaboration and team building skills; ability to connect with all levels of the organization
- Support commercial manufacturing operations at suppliers and assists in resolution of quality investigations
- Assists in maintaining effective relationships between Vertex and key suppliers of materials, technology, and manufacturing resource
- Ability to multitask to effectively manage multiple activities and projects
- Familiarity with complex data analysis, mathematical modeling and optimization software (like Matlab, JMP, Statistica, etc.)
- Knowledgeable in QbD and designed experiment methodology and implementation
- Demonstrates competency in the principles and practice of cGMPs and associated regulatory considerations in a pharmaceutical environment
- Polished written and verbal communication skills
- Ability to navigate and be successful in a fast-paced, highly matrixed work environment.
- Willingness and Ability to travel domestically and internationally (approximately 30%)
- Prefer experience in developing and/or managing Oral Solid Dosage technologies (blending, granulation, compression, film coating) or Spray Dried Dispersion
- Understanding of engineering principles for manufacturing of Oral Solid Dosage technologies or Spray Dried Dispersion to enable process scale-up, tech transfer, and/or process improvement.
- Knowledge of cGMP’s, associated CMC quality systems and regulatory considerations in a pharmaceutical setting
- Working knowledge of one or more advanced data analysis programs (e.g. Matlab, JMP, R, Statistica)
- Ability to travel both domestically and Internationally
Preferred Skills:
Experience with commercial manufacturing of spray dried dispersion and/or oral solid dosage forms
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.