Veterans Preferred – Senior Process Engineer, Manufacturing Sciences (flex)

Military Veterans are Encouraged to Apply.

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

Senior Process Engineer, Manufacturing Sciences (Flex)

This position will be part of the Manufacturing Sciences group tasked with supporting the transfer, execution, and monitoring of mRNA and novel 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.

II. Specific Duties, Activities, and Responsibilities:

• 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
• Routinely suggests new, innovative solutions to routine and complex problems
• 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.
• Supports the authoring of process descriptions and batch records, support equipment, commissioning, process training, and validation activities.
• 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.
• Authors and leads change controls and investigations.

III. Typical Position Requirements:

Education:

• Ph.D. in Biotechnology, or related field with at 0 to 2 years of biopharmaceutical process development and manufacturing experience
• MS in Biotechnology, or related field with 4 to 6 years of biopharmaceutical process development and manufacturing experience
• B.S/B.A. in Biotechnology, or related field with at least 6 to 9 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 mRNA process, chromatography, and filtration preferred
• 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
• Prior clinical and/or commercial biopharmaceutical manufacturing experience is preferred
• Experience mentoring / training staff members

Catalent 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
• 152 hours of paid time off annually + 8 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

Catalent’s standard leadership competencies that are used to interview and for Performance & Development:

• Leads with Integrity and Respect
• Delivers Results
• Demonstrates Business Acumen
• Fosters Collaboration and Teamwork
• Champions Change
• Engages and Inspires
• Coaches and Develops

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

Catalent is committed to the health and safety of its employees, visitors and the customersand patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

personal initiative. dynamic pace. meaningful work.
Visit www.catalent.com/careers to explore career opportunities.

C atalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation or gender identity. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives:Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.