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Associate Director Upstream Manufacturing

Principia Biopharma, Inc.

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Framingham, MA
LOCATION
Multiple Shifts
SHIFT

Job Description

As posted by the hiring company

Job Overview:

As part of the Sanofi Biologics Development organization in Framingham, the Drug Substance Manufacturing Biologics (DSMB) is responsible for the GMP production of cutting-edge biologic drug substance material to support clinical candidate programs. The group is responsible for transferring in and implementing the cell culture/production, purification, and formulation bioprocesses for early stage biotherapeutic clinical product candidates and works closely with the Upstream and Downstream Process Development as well as Biologics Process Engineering groups to understand each of the products that come through the area. DSMB also interacts closely with the Quality Assurance (QA), Bioprocess Engineering, Validation, and other groups to ensure cGMP’s and manufacturing schedules are maintained. Operations’ main functions are the execution of manufacturing campaigns, leading deviation investigations and managing CAPA implementation, partnering with direct manufacturing staff for enhancing and improving the manufacturing instruction set, overseeing and supporting manufacturing’s training program, and identifying and managing continuous improvement initiatives.

This role is responsible for managing an upstream manufacturing department and ensuring execution of production plan, compliance initiatives, and project/campaign scheduling across multiple shifts.

Key Responsibilities:

  • Provide managerial oversight and subject matter technical expertise (SME) to a group of individuals while also participating in on-the floor activities to ensure adequate execution of manufacturing campaigns in a multi-product GMP facility.

  • Lead adaptation of new technology into the area as appropriate

  • Ensure timely issue escalation of issues to manufacturing leadership and cross-functional support team

  • Lead cross functional teams to drive complex investigation close outs, determine root cause and implement appropriate Corrective and Preventative Action.

  • Maintain and track KPIs for the assigned area

  • Partner with other senior managers for the following:

  • - Design departmental training plan and manage execution

    - Ensure inspection readiness of assigned manufacturing areas

    - Drive/Sponsor improvements and efficiency initiatives

    - Identifies opportunities to improve manufacturing process and practices

    - Partners with Operational Excellence to drive business process improvements through Kaizens, Kanban, 5S, and VSM

Basic Qualifications:

  • Bachelor’s Degree in a Life Sciences or Engineering field such as Chemistry or Biology or related discipline with a minimum of 10 years of experience in a cGMP manufacturing environment or an Associate’s Degree (or equivalent) with 12 years of experience in a cGMP manufacturing environment

  • Extensive experience with Upstream Bioprocess unit operations/technologies and background

  • In depth knowledge of biopharmaceutical cGMP manufacturing operations

  • At least 5 years of experience in managing direct reports or teams

  • Track record in successfully demonstrating people management skills including ability to develop self, build high performance teams, develop others and maintain accountability.

  • Excellent communication skills

  • Ability to influence and build relationships

Preferred Qualifications:

  • Track record in successfully managing more than one large, complex manufacturing operation at a time

  • Experience working with cross-functional teams, including Quality, Manufacturing Technical Support, Facilities and Engineering, and Validation

  • Experience authoring and reviewing GMP procedures, documents, investigations, change controls.

  • Experience in troubleshooting, investigation, and root cause and risk analysis in a cGMP environment

  • Skilled in achieving results and managing others to achieve corporate, site, and departmental objectives.

At Sanofi R&D North America, we deliver meaningful solutions for patients. We transform science into breakthrough, best-in-class and first-in-class medicines and vaccines. We believe in creating a diverse and inclusive workforce – and workplace – which brings together the collective brainpower of over 2,000 colleagues and provides you with an exciting place to grow and develop. We set the bar high, and we deliver. Join us and together we will build on our trusted legacy of breakthroughs for society.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law

As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.

According to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.

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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.