Head Formulation and Process Development (m/f/d)

Job Overview

The Head of Formulation and Process Development (FPD) within Biologics Drug Product Development & Manufacturing (BioDPDM) organization, will be responsible for the development of combination/drug products through integrated formulation and process development for for parenteral products derived from microbial or other means within Global CMC Development’s portfolio. The Head of FPD will develop and ensure the application of global development platforms and development strategies from First-in-human studies, initial product launches and life-cycle management, as needed. The FPD site head will also have oversight responsibility for the production of drug products within their portfolio at internal Clinical Injectables Manufacturing (CIM) facilities as well as at CMOs.

Responsibilities

Site Biologics Portfolio:

• Enable expedient FIH clinical studies by developing streamlined, platform-based drug products. Develop commercially scalable, patient-centric biologics dosage forms with effective device-integration working closely with the medical devices organization optimal CoGs for global markets including China.

Develop FIH and commercial Drug Product Formulations:

• Ensure smooth technology transfers to clinical and commercial DP manufacturing facilities through initial product approvals
• Provide appropriate technical support as person-in-plant and for troubleshooting of issues
• Develop processes for scalable drug-delivery technologies through focused internal efforts and external partnerships by partnering with drug delivery and product integration function
• Provide support for life-cycle management of marketed products for formulation, component, and major process changes per LCM strategies
• Review and ensure delivery of high-quality Drug Product sections of regulatory documents (e.g., INDs, IMPDs, NDAs), Responding to Regulatory Questions (RTQs) as well as scientific & technical reports and business presentations
• Ensure timely alignment of communication, and related materials between site (FPD), functional (Bio DP&M), and organizational (Global CMC, iCMC board) entities

Strategy, Managerial, Administrative:

• As a core member of Biologics Drug Product Development & Manufacturing leadership team, the incumbent will help craft the Biologics drug product as well as technology development strategies and objectives
• Sponsor functional (within BioDPD&M) technology initiatives of limited duration, establishing and streamlining of standard business processes to improve year over year productivity
• Provide appropriate guidance to such teams to ensure timely delivery of team objectives
• Identify key talent within local and global function and ensure appropriate career development of top talent, succession planning for site FPD organization, and cross-training
• Develop and propose the FPD site budget for CAPEX, business, conference and training travel, outsourced development & manufacturing, external collaborations
• The incumbent will be responsible for an FPD department comprising of various levels of staff up to 50 team members
• Conduct periodic resource and capacity planning, identify key resource/skill gaps, and work with the Global Head of Biologics Drug Product Development & Manufacturing to address prioritization of projects, gaps in resources / skill sets, strategic hiring, etc.

Requirements & Qualifications

• PhD or equivalent in Chemical Engineering, Pharmaceutical Sciences, Biochemistry or a related discipline with minimum 10 years of work experience Biologics drug product development
• Expertise and prior experience in biologics drug product development spanning formulation, and drug product process development of multiple modalities
• Prior experience in working with early-stage, as well as late-stage projects in multiple presentation formats: Liquid and lyophilized vials, prefilled syringes, and/or cartridges
• Prior experience in regulatory submissions from INDs/IMPDs to BLAs/MAAs
• Demonstrated people-management, organizational development, as well as scientific leadership skills and eminence evidenced by peer-reviewed publications, participation in consortia & patents
• Lead and work in a multi-cultural professional environment
• Be execution oriented on delivering organizational objectives
• Foster a culture of scientific innovation, excellence and collaboration while ensuring scientific rigor in execution
• Be able to navigate across a complex organization, possess an ability to for collaborative networks within and with partner organizations
• Be a champion and change agent for diversity, inclusion, and belongingness

Our offer:

• An international work environment, in which you can develop your talent and realize ideas and innovations within a competent team.
• An attractive, market-oriented salary aligned with your qualifications and including social benefits above average (e.g. company pension plans, health management).
• An individual and well-structured introduction and training of new employees.
• You can create your own career path within Sanofi. Your professional and personal development will be supported purposefully.
• As a globally successful and constantly growing company, Sanofi provides international career paths as well.

#LI-GSA

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.