Director, Manufacturing Operations Viral Vectors

Company: Vertex Pharmaceuticals Incorporated
Location: Cambridge
Posted on: September 14, 2020

Job Description:

Cell Therapy Process Engineering, Associate Director Cambridge, MA

Job Description

In June 2019, Vertex announced the establishment of a new research site in the Boston area where research, development, and clinical manufacturing for cell and genetic therapies will be primarily based. Cell and genetic therapies represent two rapidly emerging therapeutic modalities with the potential to treat—and even cure—several of the diseases Vertex is focused on, including sickle cell disease, Duchenne muscular dystrophy and type 1 diabetes. Further investment in a research site specifically designed to advance these programs will be key to Vertex’s continued and sustained leadership in these exciting approaches. At Vertex Cell and Genetic Therapies (VCGT) our research teams will bring together the best biology, technologies and enhanced manufacturing capabilities to ensure we bring these cutting-edge transformative therapies to patients as quickly as possible.

VCGT is seeking a Cell Therapy Process Development Engineer/Scientist to join its growing team. The role will be responsible for development of Vertex’s cell therapy production platforms and will participate in development of advanced cell processing and culture systems. The Cell Therapy Process Development Engineer will work closely with the Research and Development, Manufacturing and Quality Systems teams to meet program milestones. The position will be based in Boston, MA and may require periodic travel to Vertex’s device production laboratories in Providence, RI,

Key Responsibilities:

Develop robust, scaled platform for pluripotent stem cell expansion/directed differentiation and other cell types

Develop cell isolation, purification, separation and formulation protocols and technologies in support of product development from clinical to commercial scale.

Apply DOE/QBD principals to process characterization, establish process parameters, and contribute to CMC sections of regulatory filings

Lead technology transfer to manufacturing and provide training for GMP production

Other Duties:

Coordinate and integrate the activities of various departments to ensure alignment in scope, schedule and budget. Ensure resources are being utilized on the most impactful activities.

Ensure timely completion of activities needed for Investigational New Drug (IND) applications with the US Food and Drug Administration (FDA). Support the filing activities as needed.

Partner with QA to develop and implement phase-appropriate Quality Systems for operations

Provide and confirm user input is used for the design and commissioning of the manufacturing facility and equipment

Identify raw materials and support the establishment of raw materials specifications.

Required Qualifications:

PhD in Life Sciences, bio-engineering, or related discipline with minimum 8 years of relevant industrial work experience or Master’s degree with 12 years of industry experience

3-5 years management experience preferred

5+ years of demonstrated process development experience in a bio-pharmaceutical setting working with interdisciplinary and cross-cultural teams

Experience working with cell processing devices and bioreactors

Ability to communicate effectively with a diverse range of scientists, engineers, regulatory specialists and business professionals

Preferred Qualifications:

Experience in stem cell expansion and differentiation

Demonstrable productivity in the form of patents, publications and/or presentations.

Prior experience with 50+ liter mammalian cell culture bio reactors

Experience with cell separation/selection devices

Strong knowledge of GMP requirements for cell therapy products.

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.

Posted 11 Days Ago

Full time

REQ-9493

About Us Help Us Achieve Our Mission Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has three approved medicines that treat the underlying cause of cystic fibrosis (CF) – a rare, life-threatening genetic disease — and has several ongoing clinical and research programs in CF. Beyond CF, Vertex has a robust pipeline of investigational medicines in other serious diseases where it has deep insight into causal human biology, such as sickle cell disease, beta thalassemia, pain, alpha-1 antitrypsin deficiency, Duchenne muscular dystrophy and APOL1-mediated kidney disease.

Founded in 1989 in Cambridge, Mass., Vertex’s global headquarters is now located in Boston’s Innovation District and its international headquarters is in London, UK. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia and Latin America.

Vertex is consistently recognized as one of the industry's top places to work, including nine consecutive years on Science magazine's Top Employers list and top five on the 2019 Best Employers for Diversity list by Forbes. For company updates and to learn more about Vertex’s history of innovation visit  www.vrtx.com  or follow us on  Facebook ,  Twitter ,  LinkedIn ,  YouTube  and  Instagram .

The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people’s lives.

Our vision is clear: to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work.

Keywords: Vertex Pharmaceuticals Incorporated, Cambridge , Director, Manufacturing Operations Viral Vectors, Other , Cambridge, Massachusetts