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 experience or educational background.
• Proven track record of team building, collaboration, and enabling effectiveness
• Strong knowledge of lean and Quality by Design (QbD) principles in a manufacturing environment with successful application experience
• Diverse and demonstrated technical knowledge with strong risk management mindset
• Personal Competencies: Self-awareness, Self-initiative, problem solver, solutions orientation, Team Player, Agile, Adaptability
• Computer skills (MS Office, JMP/MiniTab or equivalent statistical software, Visio, MS Project)
IV. PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS
Per CDC guidelines, Emergent strongly recommends that all employees working on site are vaccinated to help ensure their safety, as well as the safety of fellow employees. This includes the use of good judgment when determining when the CDC guidelines advise that you stay home when ill.
There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.
Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.
Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.
Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .
Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions’ approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions’ approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.
