Sr. Scientist, Process Development

Job description

Your mission

Sr. Scientist, Process Development

At Pierre Fabre Pharmaceuticals Inc. our mission is to deliver breakthrough therapies in oncology and rare diseases to patient populations with high unmet needs and limited treatment options. Our belief is that every time we care for a single person, we make the whole world better.  We are the US pharmaceutical subsidiary of Pierre Fabre Laboratories Worldwide, a foundation-owned company with 7 decades of impact. Pierre Fabre Laboratories is a truly global healthcare company, established in 43 countries, with products distributed in 119 territories across the globe. Pierre Fabre's foundation ownership enhances our ability to focus on creating long-term value for patients.    

Building on the legacy of Pierre Fabre Laboratories, innovation is our life blood and patient experience drives everything we do. We aspire to design and develop therapeutic solutions inspired by patients and healthcare professionals; draw on science and nature as perpetual sources of inspiration; develop long-term partnerships with researchers and innovators worldwide; and place pharmaceutical ethics and climate transition at the heart of our action.   

Pierre Fabre Pharmaceuticals is headquartered in Parsippany, NJ alongside Pierre Fabre USA Inc., a Pierre Fabre Laboratories subsidiary focused on dermatology and cosmetics.   

SUMMARY:  

Part of the Pierre Fabre Pharmaceuticals (PFP) Global Technical Operations team, the PD Sr. Scientist will develop and characterize cell therapy manufacturing processes and products.  This includes designing and performing laboratory activities to support process development and process characterization of PFPs cytotoxic T cell products.  He/she will be responsible for cell processing, process engineering scale-up/scale-down, bioreactor process parameters, assessment of novel technologies, cryopreservation, and equipment maintenance.  Under minimal supervision, you will be expected to design and perform experiments, organize, and carefully document results, analyze and interoperate results, and communicate findings.

  ESSENTIAL FUNCTIONS:

·  Optimize bioreactor parameters and evaluate alternative technologies.
·  Develop manufacturing processes for cell therapy products using suspension bioreactor technologies.
·  Contribute substantially to the development of process improvements and efficiencies.
·  Design and execute process development studies to develop a thorough understanding of operating and performance parameters (Design space)
·  Use engineering approaches to develop solutions to manufacturing process deficiencies.
·  Perform problem solving in the areas of bio-manufacturing and process engineering scale-up.
·  Sets up, monitor, sample and analyze cell culture processes in bioreactors.
·  Performs multiplexed cell-based assays (killing assays, mixed lymphocyte reactions, proliferation assays, etc.) for process assessment and product characterization.

·  Provide leadership to more junior team members.
·  Document laboratory procedures and experiments with great attention to detail in laboratory notebooks
·  Assist in the development of standard operating procedures, analytical test methods, and analytical sampling plans.

REQUIRED EDUCATION AND EXPERIENCE:

Required:

·  PhD in biological or engineering science with 3-5 years of industry related experience, master’s degree with 7-10+ years of related industry experience.
·  Experience with operating, optimizing, and scaling up bioreactor cultures, preferably in a cell therapy application.
·  Knowledge and experience in mammalian cell culture / biotechnology related development (aseptic operations, cell biology, biochemistry, bioreactor operations)
·  Basic analytical skills including the following techniques: multicolor flow cytometry, cell-based bioassays, ELISA, etc.
·  Ability to follow laboratory procedures with attention to detail, and successfully execute experiments at the bench.
·  Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
·  Demonstrated ability to maintain lab execution records and perform data analysis.

Preferred

·  Prior experience handling and analyzing primary human T cell function and biology space in a high-throughput setting
·  Familiarity with development and /or commercialization of cell-based therapeutics utilizing bioreactor technologies
·  Basic understanding of cGMP requirements
·  Experience using Design of Experiment (DOE)

WORK ENVIRONMENT:

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

LOCATION:

·  Aurora, CO

TRAVEL:

·  Ability to travel up to 10%. (NJ office, CDMO, Contract Labs)

Benefits of being a Pierre Fabre Employee  

Join Pierre Fabre for competitive benefits including three medical plans, dental and vision coverage, voluntary benefits, a 401(k) plan, and more! Our offerings also include a hybrid work policy, a generous

PTO policy and company holidays, paid parental leave, discounts on our products, learning and development opportunities, and access to mental health and wellness programs, creating a well-rounded work experience for our employees. 

Pierre Fabre    

Pierre Fabre has been recognized by Forbes as one of the " World's Best Employers " for the 3rd year running. 

https://www.pierre-fabre.com/en-us  

True to My Nature  

Pierre Fabre is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. 

Who you are ?

We are convinced that diversity is a source of fulfillment, social balance and complementarity for our employees, which is why our offers are open to all, without restriction.