Director of cGMP Manufacturing Job Listing at Kelly Services in San Antonio, TX (Job ID 9554513)

Description

The Director of cGMP Manufacturing will be responsible for overseeing and leading the Manufacturing teams for both Mammalian and Microbial production in a cGMP environment. This role will involve working collaboratively with the Site Leadership team, including Operations, Quality, Process Sciences, and Commercial, to support client programs.

Key Responsibilities

• Partner with QA, Operations, and Commercial to support Client Programs
• Ensure adherence to Manufacturing schedules and timelines
• Oversee proper staffing and training to support cGMP Manufacturing
• Support Technology Transfer from Process Development or External Clients
• Represent Manufacturing to outside customers and respond to their questions independently and accurately
• Collaborate with Process Sciences to modify existing R&D manufacturing processes and develop them for clinical-scale, cGMP-compliant manufacturing
• Oversee all current Good Manufacturing Practice activities, including systems, procedures, and practices
• Provide guidance in the timely resolution of investigations, deviations, change controls, CAPA, and other manufacturing or regulatory issues
• Provide career guidance, direction, ensures training and supervision of departmental staff
• Provide strategic input to executive management
• Manage relationships with outside contractors, including equipment vendors, calibration and service contracts, and validation firms  

Qualifications

• Experience with Mammalian and/or Microbial Manufacturing at clinical and commercial scale, both upstream and downstream
• M.S. or BS. in relevant scientific areas or equivalent with a minimum of 10 years of experience in cGMP manufacturing
• 15 years of leadership experience with continued increases in responsibility
• Excellent communication (oral and written), organization, and leadership skills
• Excellent regulatory knowledge of cGMP or other relevant skills, especially establishing internal and external quality systems and processes
• Prior experience in dealing with FDA and other regulatory agency personnel and understanding of their requirements/expectations
•  

Knowledge and Skills  

• Proficient with all Microsoft Office applications
• Self-motivated, customer-oriented individual with the ability to inspire and lead others
• Excellent communication skills for all levels, both internal and external clients
• Ability to work professionally with colleagues and be a team player; maintain flexibility with work projects

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As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

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