Technical Product Lead

 

We go where others won’t, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life.

I.    JOB SUMMARY 
The Technical Product Lead (TPL) role reports to the Sr Manager, Tech Transfer in the Manufacturing Sciences & Technology department of EFV.   This role is responsible for ensuring technical leadership for clients at the Camden site. The TPL partners with the client portfolio relationship manager and quality leader to provide technical subject matter expertise related to manufacturing operation activities to each client for routine, run-the-business orders, and continuous improvement efforts.  
This role leads the technical activities and is a dedication technical subject matter expert.  This role supports the Sr. Manager, Tech Transfer in day to day activities of driving MST activities.

 

II.    ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

Business
•    Ensure appropriate alignment of time, attention, and resource by working within MS&T to address technical challenges and improvement opportunities on the client’s dedicated products/processes.  
•    Enhance working relationships with internal and external partners/clients with MS&T (Client Portfolio Relationship Managers, QC, QA, EFV, Manufacturing Operations, Clients and audit organizations.
•    Responsible for working as the Client-facing team for commercial products/clients based on work scope and technical needs.
•    Track and report status on projects, activities, and responsibilities and ensure commitment to key internal stakeholders and clients is met in a timely and quality manner.

Technical 
•    Client and product-dedicated technical subject matter expert (SME) supports on going products and continuous improvement activities, with the following responsibilities 
o    Primary technical lead with CPRM team for existing commercial products
o    Leads on-going technical discussions with internal stakeholders and product teams, and clients; this includes technical problem solving, investigations, and improvement efforts
o    Contributes to internal stakeholder and client engagement operational and business management discussions 
o    Engages and collaborates with site Engineering, Facilities and Validation (EFV) teams and Operational team as required to address relevant technical matters and opportunities
o    Receives technical responsibility for new product handoff to run-the-business client management teams during new product qualification work from the Technical Project Manager(s). 
o    SME for manufacturing equipment and processes. 
o    SOP and system process authors for commercial equipment and technical processes
o    Conducts technical continuous improvement work and troubleshooting
o    Holds responsibilities for Media Fill program plan and execution, including but not limited to development of protocols, manufacturing records, execution on the shop floor and reports generation, as assigned
o    Authors Run the Business (RTB) technical subject matter deviations for assigned portfolio
o    Continued Process Verification for commercial products

People Management/Employee Development
•    Promotes our core values and progresses our culture in a positive manner (healthy cross-functional teamwork)
•    Leads continuous improvement, problem resolution and change in a positive manner
•    Strong interpersonal and communication skills (oral and written)
•    Possesses ability to negotiate and influence others internally and externally

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions. 

III. MINIMUM EDUCATION, EXPERIENCE, SKILLS
•    A degree (Bachelor) in a related field with a minimum of 8 years industry experience; Master's Degree with 5-7 years of experience; PhD with 5 years of experience. 
•    Solid technical background across a variety of scientific disciplines and fundamentals including process technologies, biopharmaceutical best practices, lyophilization, formulation development, validation, statistical analysis, regulatory submissions, and analytical methods.  
•    Experience in managing technical aspects of products in a fast paced, challenging environment, with high level of