External Manufacturing Operations Senior Manager - Boston, United States - Vertex Pharmaceuticals

Vertex Pharmaceuticals Boston, United States

3 weeks ago

Description

External Manufacturing Operations Senior Manager page is loaded

External Manufacturing Operations Senior Manager

Apply

locations

Boston, MA

time type

Full time

posted on

Posted 3 Days Ago

job requisition id

REQ-21619

Job Description
The External Manufacturing Operations

Senior Manager

is responsible for

driving technology transfer pro

jects to completion within the GMP cell processing operations team

and for

ongoing

manufacturing operations during the clinical phase of production

.

The incumbent will have

expertise

in cell culture, GMP, and exceptional project management skills

.

This

is a full-time

role

and will require

up to 50% travel, including international travel.
In this Hybrid-Eligible role, you can choose to be designated as:

Hybrid:

work remotely up to two days per week;

or
On-Site

:

work five days per week on-site with ad hoc flexibility
Key Duties and Responsibilities

:

Oversee and support

clinical product manufacturing for cell therapy according to cGMP standards

Drive

more efficient technology transfer and final process development

at CDMOs

by providing direct oversight

.

Review,

revise

and approve

controlled documentation including

SOPs

and Batch Records

for manufacturing

Ensure cGMP compliance through manufacturing oversight

,

tracking

and reporting of KPI

s

.

Manage scheduling of lots in coordination with

CDMOs and cross-functional groups

.

Responsible for

oversight

of certain

Vertex supplied raw

materials

and key CDMO deliverables

to ensure seamless operation of manufacturing activities

Manage team's projects to achieve department and corporate goals, including managing timelines and leading group meetings

Review contractual documentation and provide critical

feedback to ensure fair terms and

limit liabilities

Support the management of unexpected events

, including investigations and CAPA oversight

Serve as the technical SME for the team, troubleshoots problems independently

and provides potential solutions

Demonstrate the Vertex Phenotype behaviors:

Lead by Example; Learn, Teach & Develop; Foster Exceptional Collaboration; Drive Breakthrough Results; and Promote Enterprise Thinking

Other duties and projects as assign as

required

to meet departmental requirements

Knowledge and Skills

:

10 years in a process related science (education may contribute to experience); at least 5 years working in process development and/or

manufacturing

Excellent computer skills including Word, Excel, Project, Outlook, equipment interfaces and electronic quality systems

Demonstrated

proficiency

in

technical writing

and contract

review

Exper

tise

with

adherent and suspension

cell culture

for

GMP manufacturing

Working knowledge of federal requirements for GMP manufacturing (21CFR 210,211) and Quality Systems (21CFR 820)

Environment:

Works in a cleanroom and office setting

Must be able to remain in a stationary position 50% during

cleanroom

processing activities

Frequently move about inside the cleanroom to

oversee

process tasks

Compressed gasses and LN2 are used in this process

#LI-Hybrid
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

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