Scientist, Technical Transfer

Location: 

San Diego, CA, US, 92121


 

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 Description

The Tech Transfer Scientist serves as the overall technical subject matter expert (SME) for tech transfer of new products and processes into cGMP Production, specifically as related to materials, components and process. This position collaborates with others on development products or processes, either new or existing, and both internal or external. The individual collaborates with the team to set developmental study objectives and executes the studies in a leading role, also leading various departmental projects taking into account scientific knowledge and timing objectives. 

 

Essential Functions
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions 
•    Define and execute on process activities required to transfer processes into the San Diego GMP pilot plant, including, for example, cell banks, viral banks, and drug substance processes. 
•    Execute on the development of clinical materials in the GMP Pilot Plant, including critical evaluation of in-process data.
•    Utilize solid understanding of internal procedures, vaccine types, upstream and downstream vaccine manufacturing and protein structure for completion of applicable risk assessments, product introduction through to generation of GMP material
•    Work with the team and management to design and manage studies for process development, process optimization, scale-up, and technology transfer.
•    Lead various departmental projects taking into account scientific knowledge and timing objectives. 
•    Work with the team and management to evaluate process data and perform general analysis using scientific principles for evaluation of critical process parameters governing the performance of the process. 
•    Works with external client’s lead technical staff and senior management to evaluate complex technical details pertaining to the project and supports definition of project scope. 
•    Makes recommendations to the business development team regarding pricing of the project and assist in preparation of project proposals. 
•    Collaborate with analytical, production, quality and project management team and ensure timely completion of project deliverables.
•    Provide technical support for process activities including OOS/OOT investigation, process deviation impact, root cause investigation, process change and optimization
•    Apply cGMP and cGDP to all areas of work.

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
•    BS in Chemistry or related science and minimum of 5 years of equivalent job experience in pharmaceutical processes. At least 1-2 years of experience in a lead or supervisory role. At least 3 years experience in development or tech transfer role.
•    Strong leadership skills; high level of personal/departmental accountability and responsibility.
•    Strong knowledge of process development and process validation including critical parameter assessment and control strategy development.  
•    Ability to manage multiple priorities and tasks in a dynamic environment.
•    Proficient knowledge of cGMP. 
•    Excellent written and verbal skills.
•    Ability to exercise judgment to determine appropriate corrective actions.
•    Ability to exercise judgment for defined practices and policies in selecting methods and techniques for obtaining solutions.
•    Ability to work in a team environment and to demonstrate solid inter- and intra-departmental communication, organization and planning.
•    A solid knowledge and experience in all direct production processes including chemical handling/storage, cell build, expansion, harvest, chromatography methods, ultrafiltration/diafiltration, sterile filtration as well as a broad understanding of support processes such as equipment and component preparation (sterilization/depyrogenation), analytical, and microbiology. 
 

 

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

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


Nearest Major Market: San Diego