- Perform process technology transfer between external clients or Process Development and Drug Substance Manufacturing.
- Author and review documents including batch production records, protocols, tech transfer reports, bill of materials, process descriptions, project reports, user specifications, and summary reports.
- Perform responsibilities associated with the evaluation, alignment, and recommendation of equipment and process improvements.
- Act as the lead for technical support of risk assessments, gap analysis, deviations, change controls, and CAPAs including determination of product or process impact, root-cause analysis, and corrective action identification.
- 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.
- Perform other responsibilities to support group, site, and network-based initiatives, as required.
- Bachelor's degree in Science or Engineering and 3+ years of pharmaceutical industry experience, required
- Master's degree in science and 2+ years of pharmaceutical industry experience, preferred
- 2 years GMP or regulated industry experience, required.
- Experience with protein purification (chromatography, depth filtration, tangential flow filtration, etc.) at Manufacturing scale is preferred.
- Experience at performing technical transfer of processes and scale-up is preferred.
- Must be able to read and understand English-written job instructions and safety requirements
- Competitive medical benefits and 401K
- 152 hours of PTO + 8 Paid Holidays
- Dynamic, fast-paced work environment
- Opportunity to work on Continuous Improvement Processes
-
Application Performance Engineer
1 week ago
Country Financial Bloomington, United StatesApplication Performance Engineer Job Number: · Primary Location · :US-IL-Bloomington CC Services d/b/a Country Financial seeks an Application Performance Engineer in Bloomington, IL. Duties: responsible for improving performance testing results by influencing application desi ...
-
Northwestern Health Sciences University Bloomington, United StatesWhy NWHSU? · When you join NWHSU you're not simply doing a job, you're making a difference. You'll see passion for our mission, our work, and our future growth opportunities all around you. Culture is extremely important to us. We're a small enough organization that you'll get to ...
-
PostDoctoral Research Fellow
2 days ago
Indiana University Bloomington Bloomington, United StatesPosting Details · Position Details Title PostDoctoral Research Fellow Appointment Status Non-Tenure Track Department IU Bloomington Kinsey Institute Location Bloomington Position Summary The at Indiana University, Bloomington, is seeking to hire 2 Postdoctoral Research Fellows. ...
-
Software Engineer
1 week ago
Actalent Bloomington, United States Full timeJOB DESCRIPTION Description: · The Embedded Software Engineer leads the design of embedded software for electronic equipment including developing advanced firmware for telematics devices. Depending on the project, the employee will either work as an individual or as part of a ...
-
End User Support Specialist
3 weeks ago
On-Demand Group Bloomington, United StatesTitle: EUC Engineer · Duration: 7 month contract · Location: 100% onsite M-F 8 hours/day - Bloomington, MN · Job Description: · The End User Compute Engineer will play a crucial role in our organization's desktop and mobile computing environment. This position focuses on leverag ...
-
IT Scrum Master
1 week ago
DNI Talents Inc Bloomington, United States remoteWe are seeking IT Scrum Master - Women Returnee to join our Client's Team. As a IT Scrum Master you will be responsible for facilitating and guiding the scrum team, working closely with the product owner and development team to plan and execute sprints, daily stand-ups and sprint ...
-
Network Engineer
4 days ago
Polar Semiconductor Bloomington, United StatesWe are seeking a highly skilled and motivated Network Engineer to join our dynamic IT (Information Technology) team. Candidate will be responsible for designing, implementing, securing and supporting our growing network infrastructure. This position will provide expertise in netw ...
-
Delivery Coordinator
2 weeks ago
Brooksource Bloomington, United StatesDelivery Coordinator - Minneapolis, MN | Hybrid · Overview · The IT Program Manager will oversee and manage a portfolio of IT projects, ensuring they are completed on time, within budget, and to the highest quality standards. The ideal candidate will have a strong background in p ...
-
Business Analyst
4 days ago
Brooksource Bloomington, United StatesBusiness Analyst/Delivery Coordinator - Minneapolis, MN | Hybrid · Overview · The IT Program Manager will oversee and manage a portfolio of IT projects, ensuring they are completed on time, within budget, and to the highest quality standards. The ideal candidate will have a stron ...
-
Process Technician, Photolithography
3 weeks ago
Polar Semiconductor Bloomington, United StatesN-Shift: Sunday-Tuesday and Every Other Wednesday 6PM – 6AM · What you can do for PSL · Disposition discrepant photolithography material in a timely manner and react to priority lot holds. · Be responsive to out of control events by following established OCAPs. · Analyze failed r ...
-
Part-time Administrative Assistant
3 weeks ago
Beacon Hill Bloomington, United States Part timePosition Summary · Beacon Hill's client is seeking a Part-Time Administrative Assistant to support their HR team, CEO, and eventually the new CFO. This role is essential in handling administrative and human resources tasks. The ideal candidate will be a self-starter with the abil ...
-
Sr. Dev Ops
1 week ago
Getac, Inc. Bloomington, United States Full timeWe are a growing technology company based in Bloomington, Minnesota that offers team members opportunities to work on innovative technology, in a supportive, transparent culture. · The Company: · Getac Video Solutions (GVS) is a fiercely innovative technology company that provi ...
-
Equipment Maintenance Technician
1 week ago
FactoryFix Bloomington, United States Full timeSign-On Bonus: All new hires will receive up to $7,500 sign-on bonus (amount dependent on experience). Triple Referral Bonus: Employees will receive a $3,000 bonus for each referral who is hired.Position Summary: · Our Equipment Maintenance Technicians are responsible for perform ...
-
Systems Engineer
4 days ago
Polar Semiconductor Bloomington, United StatesThe Information System Engineer performs IT functions including design, implementation, management, and maintenance of company infrastructure and software systems in support of business objectives. Works to ensure the highest levels of availability, performance, fault tolerance, ...
-
Financial Aid Business Analyst
3 weeks ago
Indiana University Bloomington Bloomington, United States Full timeJob Summary · As a Financial Aid Business Analyst on the IA Compliance and Reporting team, the incumbent will be responsible for the following: · Department-Specific Responsibilities · Leverages knowledge of financial aid policies and processes, other student data, and financia ...
-
Field Scientist
1 week ago
Tetra Tech Bloomington, United StatesDiscover your full potential. At Tetra Tech, we are collaborating with industry-leading experts for a sustainable future for our world. We combine consulting and engineering with advanced analytics and technology to solve the world's most complex challenges. Our innovation hubs a ...
-
Python/Linux Software Engineer
1 week ago
General Dynamics Bloomington, United States Part timeBasic Qualifications · Requires a Bachelor's degree in Software Engineering, or a related Science, Engineering or Mathematics field. Also requires 5+ years of job-related experience, or a Master's degree plus 3 years of job-related experience. Agile experience preferred. · CLEAR ...
-
EA Solutions Bloomington, United States Part timeJob Description · Customer Service Part Time Computer Work from Home Job · Work from Home Online Computer Work - Administration, Data Entry & Short Studies/Feedback - Part Time & Full Time Work - No Experience Needed, Training Provided · Our company specializes in market resear ...
-
Sr. Paralegal and Legal Operations Manager
4 days ago
SkyWater Technology Bloomington, United StatesSenior Paralegal and Legal Operations Manager · Bloomington, MN, USA Req #1450 · Bold Thinking. World Changing. At SkyWater, our ingenuity helps improve lives around the world by manufacturing U.S. made semiconductors that are essential ingredients of modern life. Automotive safe ...
-
Federal Project Manager
2 weeks ago
Apex Systems Bloomington, United States Full timeJob#: · Job Description: · Project Managers are seller-doers who develop and maintain client relationships. They will have the responsibility for coordinating and leading our design teams to deliver quality projects that make our clients successful. The ideal candidate for thi ...
Senior Engineer, Manufacturing Science and Technology - Bloomington, United States - Catalent Pharma Solutions
Description
Senior Engineer, Manufacturing Science and Technology (MS&T)
Job Summary
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.
Catalent's facility in Bloomington provides a fully integrated and unique model for process development, clinical and commercial mammalian cell culture manufacturing, formulation, parenteral drug manufacturing and packaging under one roof. The award-winning facility provides clinical and commercial bulk drug substance and drug product manufacturing, including liquid and lyophilized vials, and prefilled syringes, along with an array of support services.
The Senior Engineer, MS&T works with clients to transfer and scale up of drug substance processes from development to the GMP space.
This is a fulltime, onsite role, working days; Monday – Friday.
This role offers a $10,000 sign on bonus.
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 Candidate
Why You Should Join Catalent
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 . 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 for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE ) .
