Technical Product Lead

Location: 

Baltimore, MD, US, 21230


 

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.

JOB SUMMARY 
The Technical Product Lead (TPL) role within the Manufacturing Sciences & Technology department is responsible for ensuring technical leadership for clients at the Camden site. The TPL works together with the Client-facing product and relationship manager and the client-facing Quality leader to provide the manufacturing technical subject matter expertise related to product formulation, filling, and associated finishing (inspection, labeling and packaging) activities to each client for routine, run-the-business orders, and continuous improvement efforts.  
More specifically, this role leads the technical activities for Client-facing team from Camden site, as a client dedicated technical subject matter expert. It serves as the Primary Point of Contact (PoC) with client’s technical lead and CDMO management team for above scope.  

 

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.  
•    Maintain good working relationships with internal and external partners/clients with MS&T (Client Ambassador Team, Project Management, Business Development, QC, QA, EFV, Mfg., External Clients, etc.)
•    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 

  • Primary Point of Contact (PoC) with internal product management team and client’s technical lead and CDMO management team for existing commercial products
  • Leads on-going technical discussions with internal stakeholders and product teams, and clients; this includes technical problem solving, investigations, and improvement efforts
  • Contributes to internal stakeholder and client engagement operational and business management discussions 
  • Engages and collaborates with site Engineering, Facilities and Validation (EFV) teams and Operational team as required to address relevant technical matters and opportunities
  • 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). 
  • SME for manufacturing equipment and processes. 
  • SOP and system process authors for commercial equipment and technical processes
  • Conducts technical continuous improvement work and troubleshooting
  • 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
  • Authors Run the Business (RTB) technical subject matter deviations for assigned portfolio
  • 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. 

 

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)

 

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.

ABOUT EMERGENT

Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.

Our drive towards this vision informs all of our actions—whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community—we strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES

  • Lead with Integrity
    • We gain trust and confidence through ethics, quality, and compliance excellence
  • Stand shoulder to shoulder no matter what
    • We combine our best thinking and communicate openly to support each other.
  • Own it always
    • Every person at Emergent is engaged and accountable for delivering on our commitments.
  • Break through thinking
    • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
  • Compete where it counts
    • We set the right goals and respect each other as we conquer them together.


Nearest Major Market: Baltimore