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Supervisor – Manufacturing Science & Technology, Downstream Technology Transfer
Summary:
Catalent Biologics is a fast-growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to help more and better biologic treatments get to patients. The business includes our proprietary GPEx cell line engineering platform, our new state-of-the-art biomanufacturing facility in Madison, WI, and our market-leading biologics analytical services in Kansas City, MO and Research Triangle Park, NC, as well as SMARTag Antibody Drug Conjugate technology in Emeryville, CA. Leveraging our growing differentiated technology portfolio, world class manufacturing capability, and other integrated services across the Catalent network, Catalent Biologics is positioned to drive significant growth for Catalent.
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 small, fast-growing business, backed by a global public company. People joining our team will have the opportunity for career development as our business continues to grow and expand. Catalent-Madison employees are helping to improve future patient outcomes by working on products that are designed to treat COVID-19, cancer, various autoimmune, fibrotic and blood disorders, HIV, diabetes, heart and lung diseases as well as Alzheimer’s.
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 small, fast-growing business, backed by a global public company. People joining our team will have the opportunity for career development as our business continues to grow and expand. Catalent-Madison employees are helping to improve future patient outcomes by working on products that are designed to treat COVID-19, cancer, various autoimmune, fibrotic and blood disorders, HIV, diabetes, heart and lung diseases as well as Alzheimer’s.
The Manufacturing Sciences and Technology (MS&T) department’s primary function is to serve as an agile technical services team to support process & technology transfer (e.g., mAbs, fusion proteins, mRNA, new modalities, etc.), equipment, consumables, technical writing, and drug substance lifecycle management. The MS&T organization supports the Madison facility as well as the Catalent Biologic’s network through client-facing support, on-the-floor or on-call technical coverage, and continuous improvement. The team is broken down into three key subgroups:
• MS&T, Upstream Technology Transfer
• MS&T, Downstream Technology Transfer
• MS&T, Operational Engineering
• MS&T, Technical Writing
The Technology Transfer groups are the technical liaisons between Process Development (internal or external) and at-scale GMP manufacturing relating to process transfer. This function includes drafting and supporting required batch documentation (i.e., gap assessments, reports, batch records, product impact), as well as process modeling and facility fit including initial bill-of-material development.
This is a full-time on-site position, Monday – Friday 8:00am-5:00pm.
Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.
The Role:
The Supervisor will be responsible for the drafting and review of documentation, compilation, and assessment of applicable data, change management, utilization, and monitoring while providing technical input for deviation investigations, change controls, and CAPAs. This position will be client-facing and should possess the ability to work collaboratively with clients and internal cross-functional stakeholders to move projects forward.
• Use comprehensive knowledge of applicable principles, concepts, and practices and/or techniques to lead complex projects within a department, group, or team in a single function or focus.
• Apply technical and functional knowledge to design experiments/projects that contribute to the overall direction of the department/discipline.
• Lead a group of 5 to 12 direct reports.
• Manage strategic or continuous improvement activities across the teams within the department or across multiple departments within the site. Coordinate with teams in other departments and across business unit.
• Work cross-functionally with Process Development, Manufacturing, Quality Assurance, Quality Control, Supply Chain, Project Management, Facilities, and other departments to effectively transfer and maintain processes in the facility.
• Responsible for maintaining a high-performing team by hiring, training, motivating, evaluating, and developing staff (direct reports and others).
• Lead a team in technical support of Manufacturing, including the technology transfer between external clients or Process Development and Manufacturing.
• Lead a group of engineers, scientists, and other colleagues to drive the facility fit and technical transfer of mammalian biological processes.
• Responsibilities associated with the evaluation, alignment, and recommendation of equipment and process improvements.
• Support technology transfer of processes into manufacturing for both internally and externally developed processes.
• Other duties as assigned.
The Candidate:
• Bachelor’s degree in a STEM discipline and 8+ years related experience, OR
• Master’s degree in a STEM discipline and 5+ years related experience, OR
• Doctorate Degree in a STEM discipline and 2+ years related experience
• Previous experience in a people leadership or lead role preferred.
• Downstream experience (e.g., depth filtration/clarification, chromatography, tangential flow filtration, viral filtration, BDS fill, etc.) manufacturing processes across cGMP biologics production scales cGMP required.
• Experience in facility fit, process scaling, and technology transfer required
• Demonstrated working knowledge of Tech Transfer between Development and Manufacturing, including the ability to operate within a clean room environment required
• Excellent written and verbal communication skills with internal and external customers.
• Experience with operating and troubleshooting process equipment, including single-use systems and consumables preferred
• Experience working on late phase, process performance qualification, and commercial programs is a plus
• Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, GM Excellence, and GROW) may be considered in place of external experience.
Safety and Environmental Requirements:
• May be exposed to inclement weather or be required to work in environments or under conditions that require the use of protective gear and/or awareness of personal safety and safety of others.
• Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening.
• Occasional stooping, kneeling, crouching, bending, carrying, grasping.
• Frequent lifting and/or moving up to 20 pounds and occasional lifting and/or moving up to 50 pounds.
• Must comply with EHS responsibilities for the position.
• Working conditions will be heating ventilation and air condition controlled.
• Working in a lab environment will require working with skin irritants, lung irritants, electrical equipment, sharp instruments, toxic materials, and hazardous waste. Safety procedures will be followed to minimize exposure, including clean room gowning.
Why you should join Catalent:
• Defined career path and annual performance Senior Process Engineer
Position Summary:
Catalent Pharma Solutions is Chelsea, MA is hiring a Senior Process Engineer who is responsible for the design and implementation of chemical processes, instrumentation and equipment. This individual provides expertise in engineering, design and process and/or scale-up; assists manufacturing operations in problem solving with regards to equipment and systems; develops and recommends new process formulas and technologies to achieve cost effectiveness and improved product quality. This individual establishes operating equipment specifications and improves manufacturing techniques.
This is a full-time role position: Monday – Friday, days. 8:00PM – 5:00PM
Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives.
This 90,000 square-foot Boston-area facility is Catalent’s global Center of Excellence for spray dry dispersion and Dry Powder Inhaler (DPI) capsule manufacture and packaging. The site features inhaled powder spray drying, as well as multiple commercial-scale lines for capsule filling and blister packaging. On-site spray dryers include best-in-class GEA Niro SD1, SD4 and SD7, the latter being the largest CGMP unit of its kind for DPI in North America.
Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.
The Role
• Provides start-up, commissioning and validation support for a commercial scale spray dryers, secondary dryers, encapsulators, and blistering equipment;
• Designs, conducts and coordinates engineering studies to drive the development and understanding of Catalent Chelsea’s dry powder technology platform;
• Leads technical aspects of equipment/process investigations;
• Provide SME leadership in technology transfer and scale up activities;
• Leads problem solving initiatives with regards to equipment and systems;
• Supports manufacturing and engineering operations by participating in the following: Draft and maintain Standard Operating Procedures and Batch Records, Production support, and Training of operators;
• Conducts analysis of engineering data and provides recommendations for future process improvements;
• Participates in the identification and evaluation of new technologies and product opportunities;
• All other duties as assigned;
The Candidate
• Bachelor’s degree in Chemical Engineering (preferred), Mechanical Engineering, pharmaceutical sciences or related field required;
• A minimum of 5+ years of relevant experience required;
• Experience working in an FDA regulated operation, preferably in the pharmaceutical/biotechnology area;
• Knowledge of Good Manufacturing Practice requirements required;
• Demonstrated knowledge of equipment/process operating and design competencies preferred;
• Strong process and mechanical hands-on capabilities required;
• Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds;
Why you should join Catalent:
• Defined career path and annual performance review and feedback process
• Diverse, inclusive culture
• 152 hours of PTO + 8 paid holidays
• Several Employee Resource Groups focusing on D&I
• Dynamic, fast-paced work environment
• Positive working environment focusing on continually improving processes to remain innovative
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• Competitive salary with bonus potential
• Community engagement and green initiatives
• Generous 401K match
• Medical, dental and vision benefits effective day one of employment
• Tuition Reimbursement – Let us help you finish your degree or earn a new one!
• WellHub program to promote overall physical wellness
• Perkspot – offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories
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 customers and 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 Catalent Careers to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and veterans.
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.
California Job Seekers can find our California Job Applicant Notice HERE.
