Sr. Manager, Process Development

Job description

Your mission

Sr. Manager, 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:  

The Sr. Manager - (Manufacturing & QC Support) position will manage and lead the Production Services team at Atara.  The team is responsible for producing and maintaining a library of different cell types from multiple donors.  The cells from that library are then used in QC release assays for Pierre Fabre Pharmaceuticals (PFP) drug products.  In addition, the team is responsible to screen donor cells and reagents prior to use in GMP manufacturing of drug product.  The position will work cross functionally with QA, QC, manufacturing, supply chain, and process development to ensure that operations are being executed under the appropriate degree of GMP compliance and that manufacturing and QC requirements are met in a timely manner.

ESSENTIAL FUNCTIONS:

·  Manage the production of a comprehensive library of various antigen presenting cells as assay reagents.
·  Mange the testing and releasing of assay reagents (antigen presenting cells).
·  Manage the screening and testing of donor cells to assess the appropriateness of the cells to be used in GMP manufacturing process
·  Coordinates with manufacturing and QC groups to make sure assay reagents are available and delivered in time to support GMP manufacturing and release test of drug product.
·  Collaborate with quality colleagues to ensure operations are following the appropriate level of quality and controls.
·  Manage Production Services team of approximately 4-6 employees
·  Assists in maintaining laboratory, monitoring lab inventory and ordering supplies.

WORK ENVIRONMENT:

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

LOCATION:

·  Aurora, CO (Fitzsimons Innovation campus)
·  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.