Director, Manufacturing Sciences - Madison, WI | Biospace
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Director, Manufacturing Sciences

Catalent Pharma Solutions, Inc.

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Location:
Madison, WI
Posted Date:
5/18/2017
Position Type:
Full time
Job Code:
0021528
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Director, Manufacturing,

Job Description


Catalent Biologics is hiring for a Director, Manufacturing Sciences for Catalent’s state of the art biomanufacturing facility in Madison, WI. This is a brand new facility with cutting edge biomanufacturing capabilities. It’s an exciting time to join Catalent! Catalent is aggressively growing in biologics, and is making significant investments in people and capabilities in this area.  

The Director will lead the technical transfer activities into Manufacturing for both internal and external processes. Hires, trains, motivates, leads, develops and evaluates staff. Takes corrective action as necessary on a timely basis and in accordance with company policy. Ensures compliance with current federal, state and local regulations. Consults with Human Resources Department as appropriate. Informs personnel of communications, decisions, policies and all matters that affect their performance, attitudes and results. Supports the validation of processes and preparation for commercialization. Manage steam responsible for facility fit activities; including process flow diagram generation, scale-up calculations, defining equipment and solution requirements, generation bill of materials (BOM) and new specifications while insuring safety and quality standards are maintained. In addition, the Director will:

•   Work closely with manufacturing to provide on-the-floor technical oversight before and during GMP runs.
•   Prepares and reviews technical documents including batch records, formulation/solution/media records, item specifications, project reports, and engineering specifications.
•   Leads the compilation of process data, including communicating project status, and delivering internal / client presentations.
•   Acts as the lead for technical support deviations, change controls, and CAPAs including determination of event impact, root-cause analysis and corrective action identification.
•   Evaluates existing processes and identifying process and/or equipment improvements to improve efficiency, consistency and competitiveness. This includes development of project requirements, scope of work, technical design, and cost justification for management evaluation
•   Oversees the alignment and direct technical transfer across departments (PD, manufacturing, Quality) in an effort to launch and support new products

About Catalent Biologics:

Catalent Biologics is a fast growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to help more and better biologic treatments get to patients.  The business includes our proprietary GPEx cell line engineering platform, our new state-of-the-art biomanufacturing facility in Madison, WI., and our market leading biologics analytical services in Kansas City and Research Triangle Park, NC.  With the recent acquisition of Redwood Bioscience in Emeryville, CA, we have added the SMARTag Antibody Drug Conjugate technology, providing a next-generation ADC platform to our biologics customers.  Leveraging our growing differentiated technology portfolio, world class manufacturing capability, and other integrated services across the Catalent network, Catalent Biologics is positioned to drive significant growth for Catalent. Working for Catalent Biologics is an opportunity to join an entrepreneurial team that is building a new business.  Catalent is aggressively growing in biologics, and is making significant investments in people and capabilities in this area.  This is a unique opportunity to join a small, fast growing business, backed by a global public company.  People joining our team will also have significant career development/progression opportunities as our business continues to grow and expand.

About Catalent

Catalent offers rewarding opportunities to further your career – join the global drug development and delivery leader! You will help develop some of the nearly 200 products we launch each year or help supply some of the over 7,000 products for patients globally. Our highly skilled, dedicated global team of over 9,500 is passionate about improving the health of patients by combining their personal expertise with advanced technologies to advance science and supply innovative new products of the highest quality to patients around the world.

Catalyst + Talent. Our name combines these ideas. From drug and biologic development services, to delivery technologies to supply solutions, our highly skilled and dedicated global team of over 9,500 is passionate about improving health and wellness by combining their personal expertise and advanced technologies to advance science and supply products of the highest quality to customers and patients around the world.

Our VISION is to be the world’s most trusted, reliable and innovative drug development and delivery partner by upholding the highest industry standards and exceeding customer expectations while driving strong, sustained growth for the company.

Our MISSION is to develop, manufacture and supply products that help people live better, healthier lives.

OUR VALUES are at the foundation of everything we do:

•          Patient First:  We put patients at the center of our work to ensure the safety, reliable supply and optimal performance of our products
•          Customer Dedication: We strive to exceed our customers’ expectations every day
•          People: We are committed to the growth, development and engagement of our people
•          Innovation: We develop and apply innovative solutions, superior technologies and continuously improved processes
•          Integrity: We demonstrate respect, accountability and honesty in every interaction
•          Excellence: We have a passion for excellence in everything we do.

Requirements


•   PhD in Biotechnology, or related field, with minimum of 8 years of relevant experience; or M.S./M.A. in Biotechnology, or related field, with minimum of 12 years of relevant experience; or B.S./B.A. in Biotechnology, or related field, with minimum of 14 years of relevant experience.
•   Experience with Upstream and/or Downstream processes at the small to intermediate scale of cGMP biologics production
•   Prior experience in process scaling and technology transfer
•   Experience in report and documentation skills
•   Experience in investigating and closing out deviations, OOS and CAPAs
•   Experience writing and revising standard operating procedures and batch production records
•   Experience with operating and troubleshooting process equipment
•   Experience working on late phase and commercial programs is a plus
•   Ability to use Excel, Word, and other office systems, as well as programs for multiple pieces of manufacturing equipment.
•   Ability to peer review data to ensure data is well organized with complete documentation.
•   Ability to independently interpret data, analyze trends and provide insight into potential issues and subsequent solutions.
•   Ability to problem solve to initiate and execute/monitor corrective action.
•   Ability to write SOPs, batch production records and reports independently