Associate Director, Drug Product Development

Employer
CSL Behring
Location
Holly Springs, North Carolina
Posted
Jan 29, 2021
Ref
R-127822
Required Education
Bachelors Degree
Position Type
Full time
About CSL

With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

Job Description

Job Purpose:

The prospective scientist provides scientific expertise for the design, planning, and execution of drug product development projects. Supports drug product development from early phase to late phase through formulation and process improvements. The individual will provide scientific expertise to ensure studies are well thought out and have clear, measurable benefits. Leads and drives elements of these activities as required.

Major Responsibilities:

Process and Product Development:
  • Collaborates with R&D senior staff to craft technical strategy for development of new drug products and life cycle management of legacy products
  • Leads drug product development for key strategic projects including adjuvanted and non-adjuvanted flu antigen vaccines and RNA based vaccines
  • Provides technical subject matter expertise in the drug product development space including formulation development, lyophilization, and delivery device design and selection for biologics
  • Oversees drug product development projects through early development stage gates including technical transfer from Research, formulation development, device design and development, and non-clinical and early phase clinical production
  • Author key technical documentation including product and process development plans, contract development and manufacturing proposals, quality target product profiles (QTPP), and technical transfer plans
  • Proactively identifies legacy product improvement opportunities
  • Proactively identifies innovation opportunities in drug product formulation and delivery (e.g. micro-needle patch)
  • Provides technical oversight of product and process development activities sub-contracted to 3rd party development and manufacturing organizations
  • Represent TD on cross functional core project team(s) to provide program oversight, and define and drive program strategy


People Management:
  • Drives culture of safety, ensures team adheres to requirements, and identifies and implements improvements
  • Maintains a state of compliance for team and self through regular review of training and implementing training curricula improvements
  • Provides ongoing performance feedback, technical guidance and mentorship to drug product development team
  • Provides project and program level leadership within TD and in cross functional project teams
  • Produce high quality technical presentations for internal audiences including senior management to update on project/program technical progress


Operations/Quality Support:
  • Serves as interface between TD and Operations, and represents TD department in cross-functional forums to support manufacturing and QC
  • Utilizes knowledge and experience of drug product processes to provide technical support for production of drug product in GMP manufacturing
  • Uses scientific and statistical knowledge to support product, process and testing related investigations and deviations including complaint, deviation, OOE and OOS investigations that require support TD

Minimum Qualifications:

  • Bachelor's or Master's Degree or PhD in related scientific field
  • 12+ years with BS, 10+ years with MS or 8+ years with PhD - experience in relevant industry position(s)
  • Broad technical expertise in drug product development including formulation, stability, analytical characterization, lyophilization, and delivery device design and selection for biologics
  • Experience with novel drug delivery technologies (e.g. microneedle patch, nanoparticles) ideal
  • Experience with emulsion chemistry ideal
  • Uses broad and comprehensive technical, scientific or professional knowledge and experience to manage the outcomes and actions of a variety of complex projects
  • Extensive experience in exploratory data analysis and statistical techniques including design of experiments
  • Extensive experience writing content for technical documentation including product and process development reports, regulatory CMC license sections and presentations
  • Excellent communication and interpersonal skills with demonstrated ability to lead, drive and motivate people to achieve goals
  • Demonstrated ability to deliver technical aspects of drug product development projects in a cross functional working environment which includes R&D functions (Research, Reg CMC, R&D QA, Clinical, etc.) and Operations functions (QA, QC, MS&T, Engineering, etc.)
  • Flexible and adaptable attitude with the ability to support change management
  • Role model and promote CSL/Seqirus values
  • Experience managing teams of individual technical contributors (i.e. scientists, engineers) and direct reporting personnel in leadership roles (i.e. manager of managers)