Senior Process Engineer, Manufacturing Sciences

at Catalent
Location Madison, Wisconsin
Date Posted February 10, 2021
Category BioPharma
Job Type Full-time
Address 726 Heartland Trail, Suite 100

Description

Job Description

Position Overview: 

Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent’s advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love.  Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here

 

 

Position Summary

Working for Catalent Biologics is an opportunity to join an entrepreneurial team.  Catalent Biologics is making significant investments in people and capabilities.  This is a unique opening to join a fast-growing business, backed by a global public company.  The Product Development network supports development of biologic modalities (mAbs, novel protein modalities, mRNA, exosomes, enzymes, viral proteins) from initial early phase through late stage projects to PPQ and launch. Catalent Biologics is building and leveraging best-in-class process, formulation and bioanalytical platforms to drive solutions. In addition, the Biologics business unit continues to develop technology in-house and evaluates potential external offerings. Development teams at Madison and Bloomington design and conduct process, analytical, and formulation work. For scale-up, the US based teams in Manufacturing Science and Technology (MS&T) support tech transfer for DS and fill finish (Catalent or client developed processes). Catalent-Madison employees are helping to improve future patient outcomes by working on products that are designed to treat cancer, various autoimmune, fibrotic and blood disorders, HIV, diabetes, heart and lung diseases as well as Alzheimer’s.  

The Senior Process Engineer is part of the Manufacturing Sciences group tasked with supporting the transfer, execution, and monitoring of mammalian cell culture and purification processes in our manufacturing suites. The position will support the site’s strategic plan by working with Consultants, Manufacturing and Quality personnel to manage the deliverables required to prepare the Madison, WI site for early Phase and Phase III/Commercial manufacturing. The Senior Process Engineer will support the tech transfer, scale up, and process documentation required to transfer Phase I-III/Commercial processes from Process Development into Manufacturing or external transfer programs.  They will also manage specific client requests, attend client meetings, and understands uniqueness of each process.  Support the Program Managers and Commercial Readiness Team and drive the closure of process gaps or Improvements                                                                                                                                                           

The Role

  • Uses comprehensive knowledge of principles, concepts and practices and/or techniques to lead complex projects within department and cross functionally

  • Applies technical and functional knowledge to design experiments or projects that contribute to overall direction of department; Skilled at risk mitigation and prediction

  • Recommends process scale-up of biological processes, leads gap analyses to identify key process parameters and equipment needs to facilitate process transfer into manufacturing.

  • Support technology transfer process (both internal and external) to support both clinical and late phase production.

  • Leads facility fit activities for existing and future internally and externally transferred processes.

  • Champions best practices and drives adoption into the manufacturing group to improve clinical and commercial production processes.

  • Subject matter expert for equipment and process troubleshooting.

  • Leads technical deviation investigations and collaborate with Operations and Quality teams to determine the impact, root cause, and corrective actions for the deviation.

The Candidate

Education:

  • Ph.D. in Biotechnology, or related field with at 0 to 2 years of biopharmaceutical process development and manufacturing experience

  • Master’s degree in Biotechnology, or related field with 4  years of biopharmaceutical process development and manufacturing experience

  • Bachelor’s degree in Biotechnology, or related field with at least 6 years of biopharmaceutical process development and manufacturing experience

Experience:

  • 1+ years of relevant work experience in a current Good Manufacturing Practices (cGMP) environment with progressive responsibilities

  • Knowledge of mammalian upstream and / or downstream processes

  • Experience with writing and reviewing standard operating procedures and batch production records, as well as supporting and leading deviation investigations

  • Subject matter expertise with operating, maintaining, and troubleshooting disposable stirred vessel bioreactors and/or protein purification utilizing chromatography systems

  • Mammalian cell culture experience is preferred

  • Prior clinical and/or commercial biopharmaceutical manufacturing experience is preferred

  • Experience mentoring / training staff members

  • Knowledge of mRNA processing preferred

  • Knowledge of Cleaning Validation/Verification preferred

Experience:

  • Knowledge of current Good Manufacturing Practices (cGMP) environment

  • Lab experience including engineering based design or experimentation

  • Leadership experience for cross functional teams

  • Knowledge of mRNA processing preferred

  • Knowledge of Cleaning Validation/Verification preferred

Catalent’s standard leadership competencies  

  • Leads with Integrity and Respect

  • Delivers Results

  • Demonstrates Business Acumen

  • Fosters Collaboration and Teamwork

  • Champions Change

  • Engages and Inspires

  • Coaches and Develops

 Position Benefits

  • Defined career path and annual performance review and feedback process

  • Diverse, inclusive culture

  • Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives

  • 19 days of paid time off annually + 7 paid holidays

  • Competitive salary with yearly bonus potential

  • Community engagement and green initiatives

  • Generous 401K match and Paid Time Off accrual

  • Medical, dental and vision benefits effective day one of employment

  • Tuition Reimbursement

  • On-site fitness center and wellness programs

 

Click here to learn more & apply today!