Senior Director Manufacturing

Fraser Dove International; Pennsylvania; On-site; USD 195,000 - 250,000; Full time

Job summary

Fraser Dove International is seeking a Senior Director of Manufacturing Operations, Clinical to lead clinical manufacturing operations for a leading biologics organization. This executive role involves strategic oversight of multiple manufacturing campaigns in a GMP environment, emphasizing operational excellence and team leadership to advance gene therapy solutions.

Qualifications

• 12+ years of GMP biologic manufacturing experience.
• Extensive experience with upstream/downstream processing.
• Strong leadership experience managing teams (6+ years).

Responsibilities

• Oversee clinical production operations in 24/7 GMP environment.
• Manage multiple teams across manufacturing campaigns.
• Ensure compliance with GMP standards and readiness for inspection.

Skills

Leadership

GMP Compliance

Technical Transfer

Clinical Manufacturing Expertise

Education

BS in Engineering/Science

MS in Engineering/Science

Job description

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Associate Consultant | TechOps & Quality | Executive Search | Helping Pharmaceutical Companies Transform Through Executive Search & Our Talent…

Senior Director of Manufacturing Operations, Clinical

Are you a strategic manufacturing leader with deep expertise in gene therapy?

Do you excel in leading clinical manufacturing campaigns in a GMP environment?

Ready to shape the future of biologics manufacturing for life-changing therapies?

Fraser Dove International is partnering exclusively with a

leading biologics organisation. Operating in the United States,

they are committed to advancing gene therapy solutions through innovative manufacturing.

Our client is seeking a visionary leader to oversee and scale clinical manufacturing operations in a multi-program, GMP-regulated environment.

Discover more about our Senior Director of Manufacturing Operations, Clinical opportunity; its

objectives, duties/responsibilities and the skills, experience and competencies

needed to succeed.

Your objectives:

As the Senior Director of Manufacturing Operations, Clinical, you will be measured against the

following objectives:

• Ensure successful execution of multiple clinical manufacturing campaigns across upstream and downstream operations.
• Drive operational excellence, including consistent manufacturing readiness, tech transfer and inspection readiness.
• Lead, mentor, and retain high-performing teams aligned with organisational and client goals.

What you will do:

As the Senior Director of Manufacturing Operations, Clinical, your duties and responsibilities will

include:

· Oversee upstream and downstream clinical production operations in a 24/7 GMP environment

· Manage multiple teams across manufacturing campaigns and shifts.

· Lead successful technical transfers of clinical manufacturing projects in collaboration with Tech Transfer teams.

· Troubleshoot and resolve equipment and process issues with clinical production staff

· Ensure documentation, procedures and specs comply with GMP standards and remain inspection-ready.

· Work closely with Project Management and Commercial Operations to maximise capacity and accelerate programs.

· Serve on the Site Leadership Team and translate business goals into actionable KPIs for manufacturing operations.

What you will bring:

These are the skills and experience you will need to succeed

as the Senior Director of Manufacturing Operations, Clinical:

· 12+ years of GMP biologic manufacturing experience with a BS in Engineering/Science, or 10+ years with a MS.

· Extensive experience with upstream/downstream processing in mammalian or microbial cell culture.

· Demonstrated success in CDMO/CMO clinical manufacturing environments.

· Strong leadership experience, with at least 6 years managing teams.

· Ability to inspire clients and stakeholders through strong execution and mitigation of challenges.

· B.S. or M.S. in Engineering or a related scientific discipline.

· Formal training in GMP manufacturing or operational leadership.

Got what it takes?

To apply for the Senior Director of Manufacturing Operations, Clinical, click the ‘Apply’ button below, or contact the Executive Search Consultant – [ REECE WIGGINS ] – on +44

(0)203 355 7050.

Please Note:

· This job description in no way states or implies

that these are the only duties to be performed by the employee(s) incumbent in

this position. Employee(s) will be required to follow any other job-related

instructions and to perform any other job-related duties requested by any

person authorised to give instructions or assignments.

· If you have not heard from an Executive Search

Consultant within ten working days from the date of your application, please

consider yourself unsuccessful on this occasion.

· We use the information in your application to

support your job search, contact you with relevant opportunities and to improve

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view our Privacy Policy available on our website:

Fraser Dove International is a specialist executive search

firm operating exclusively in the life science industry. Passionate about

people, we take pride in helping exceptional life science organisations source

the talent they need to design, manufacture and distribute life-changing drugs,

treatments and devices which transform and save patient lives.

Seniority level

• Seniority level

  Executive

Employment type

• Employment type

  Full-time

Job function

• Job function

  Manufacturing and Strategy/Planning

• Industries

  Pharmaceutical Manufacturing

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