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12 days old

Sr. Director Manufacturing Operations

Kelly Services
The Woodlands, TX 77381
**We are Kelly Science and Clinical** **,** the second largest scientific staffing firm in the U.S. serving 90% of Fortune 100 companies. We have partnered with a growing, award-winning biopharmaceutical contract development and manufacturing organization providing fully integrated, drug development and biopharmaceutical services to pharmaceutical and biotechnology companies globally. Company has a pro-employee culture, and its core values include collaboration, partnership, honesty, career development, work-life balance and rewarding employees.


**Job Title:** **Sr. Director Manufacturing Operations (Cell Therapy)**


**Overview:**


Our client is immediately seeking a Sr. Director, Manufacturing Operations who will manage the operations and staffing associated with the cGMP production of Cell and Gene Therapy Drug Products with **this fast-growing, team-based, collaborative** cGMP cell therapy manufacturing facility. You can really make a difference in this role!


**Responsibilities may include (but are not limited to) the following:**


+ Leads and directs the group supporting GMP manufacturing of bulk drug substance cell therapy (Biologics).

+ Manage QA oversight of on-going GMP Manufacturing activities. Performs QA-on-the-floor inspections.

+ Manage multiple teams of manufacturing managers and associates to ensure safety, compliance, and production goals are reached.

+ Collaborate with Technical Operations to manage the work flows associated with new product introduction and product reintroduction including design of process flow, equipment fit, bill of materials (BOM) generation, process parameters, automation requirements, and chromatography methods.

+ Review and approve batch records, solution records, and other SOPs for new/existing products.

+ Review and approve deviation investigations, CAPA's, technical documents, and Change Controls associated with production areas. Ensure appropriate root cause investigations are completed and effective corrective/preventative actions are implemented.

+ Partner with Engineering provide technical expertise for the identification of new manufacturing equipment and equipment suitability for new processes.

+ Manage the implementation of new manufacturing equipment and change over optimization of existing equipment in preparation for use in cGMP operations.

+ Provide on-the-floor technical oversight and manage client interactions as required during cGMP manufacturing runs.

+ Serve as SME as required during regulatory inspections for deviations, change controls, and process documentation.


**Education/Experience Requirements/Competencies** **:**


+ Legally authorized to work in the job posting Country.

+ Minimum BS/BA and 10+ years experience or equivalent.

+ Broad based knowledge of upstream and/or downstream processing techniques and equipment for microbial processes.

+ Experience working in a cGMP manufacturing environment is required.

+ Experience with technical transfer is desired. Ability to perform process calculations to complete technical transfer analysis including but not limited to mass balances, cycle analysis, feed rate calculations, ratio determinations, and step yields.

+ Ability to respond to questions from groups of managers, clients, and customers.


**Generous Compensation and Benefits Package Including Relocation Assistance EOE, including Disability/Vets**


**\#TJP2021_SPEC**


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-11-15 Expires: 2021-12-16

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Sr. Director Manufacturing Operations

Kelly Services
The Woodlands, TX 77381

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