Supervisor/ Sr. Specialist, Cell Manufacturing Operations
Company: Vertex Pharmaceuticals
Location: Cambridge
Posted on: May 16, 2022
Job Description:
Job DescriptionGeneral Summary: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, including the set-up, assembly, operation, disassembly,
and cleaning of process equipment, and overseeing the daily work of
shift personnel. Responsible for daily operation and staff
allocations for second shift personnel.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 and witness batch record instructions during cGMP
operations.
- Maintain facility in an audit ready state.
- Supervise manufacturing personnel
- 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 follow verbal and written instructions in
English.
- Visual Acuity.
- Ability to distinguish between the colors red, yellow, blue and
green.
- 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.
- May require alternate (II, or III shift) work,
- Occasional availability to work on other shifts may be
necessary for onboarding and training.Education and Experience:
- Bachelor's degree in a scientific, technical or engineering
discipline
- Typically requires 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#LI-KW1Company InformationVertex 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.
Keywords: Vertex Pharmaceuticals, Cambridge , Supervisor/ Sr. Specialist, Cell Manufacturing Operations, Other , Cambridge, Massachusetts
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