Supervisor, Manufacturing Operations - cGMP

Company: Vertex Pharmaceuticals
Location: Providence
Posted on: May 21, 2023

Job Description:

Supervisor, Manufacturing Operations - cGMP page is loaded Supervisor, Manufacturing Operations - cGMP Apply locations Providence, RI time type Full time posted on Posted 3 Days Ago job requisition id REQ-18730 Job DescriptionIn 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.The Supervisor, Manufacturing Operations leads shift work in the art manufacturing facility, assigning work according to detailed schedules and plans. Responsible for daily cGMP operations in the Vertex Drug Product Facility, this role will focus on the fabrication of cell encapsulation devices for delivering proprietary cells, including manufacturing of all components and final assembly of the finished device. including the set-up and cleaning of process equipment and overseeing the daily work of shift personnel. Responsible for daily operation and staff allocations for second shift personnel. The Successful Candidate will join the Device Manufacturing Team and work closely with the Device Process Development, Device Quality Control, and Device Quality Assurance Functions, as required. -The position will be located in Providence, R.I. Must be able to work 1st Shift Hours: 6:00 AM - 2:30 PM Key Duties and Responsibilities:

• Interface with relevant cross functional groups necessary for the operation and maintenance of the facility and manufacturing of drug product.
• Execute, witness and reviewing batch record instructions during cGMP operations.
• Maintain facility in an audit ready state.
• Supervise manufacturing personnel.
• Plan work activities, and adapt to changing Production Schedules and other conditions, as required.
• Monitor GMP compliance in all cGMP activities with co-workers and anyone working within the Drug Product facility.
• Maintain compliance with all on-going training requirements.
• Follow SOPs, policies, and all other relevant work instructions to ensure the successful and compliance operation of the drug product facility. Knowledge and Skills:
  • Ability to lift up to 50lbs.
  • Strong organizational skills.
  • Strong communication skills, as well as excellent documentation skills.
  • A solid understanding of the cGMP framework in the context of both development and commercial pharmaceutical drug product manufacturing environment.
  • Basic computer skills and demonstrated ability to learn new systems and understand new technologies. Education and Experience:
    • Bachelor's Degree in a scientific, technical or engineering discipline with 3+ years of experience or the equivalent combination of education and experience
    • Supervisory experience
    • Experience with manufacturing systems utilizing computerized control systems and HMIs
    • Experience with continuous manufacturing and with solid oral dosage manufacturing processes
    • Flexible to work extended hours, and weekends, as required.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. Please note that Vertex requires COVID-19 vaccination for all employees working in the U.S. as a condition of employment at Vertex, subject to medical, religious or other accommodations or exemptions required by law. We believe this requirement is vital to keeping everyone at Vertex and in our communities safe. This requirement applies to both existing and new employees who may at any time work on-site at a Vertex facility or visit another location on behalf of Vertex (e.g., conferences, customer visits, etc.), including all remote employees. 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. Similar Jobs (5) 2nd Shift - Supervisor, Manufacturing Operations locations Providence, RI time type Full time posted on Posted 30+ Days Ago Manufacturing Operations Senior Technician - 2nd Shift locations Providence, RI time type Full time posted on Posted 30+ Days Ago 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 multiple 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 small molecule, cell and genetic therapies in other serious diseases where it has deep insight into causal human biology, including sickle cell disease, beta thalassemia, APOL1-mediated kidney disease, pain, type 1 diabetes, alpha-1 antitrypsin deficiency and Duchenne muscular dystrophy.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. 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 13 consecutive years on Science magazine's Top Employers list and one of Fortune's Best Workplaces in Biotechnology and Pharmaceuticals and Best Workplaces for Women. 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. ALERT: If you have signed up for Job Alerts, please be aware that Job Alert Matches are currently not working. During this time, please check our careers site regularly for all open opportunities. We apologize for this systems issue and hope for it to be resolved soon.

Keywords: Vertex Pharmaceuticals, Providence , Supervisor, Manufacturing Operations - cGMP, Other , Providence, Rhode Island