Catalent
Senior Scientist, QC
Catalent, Bloomington, Indiana, United States, 47401
We're hiring a Senior Scientist, QC to support the environmental testing team in Bloomington, Indiana!
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 is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.
Catalent Biologics in Bloomington, Indiana is a state-of-the-art, GMP manufacturing facility, providing one million sq/ft of drug substance manufacturing, drug product manufacturing, and related pharmaceutical services. This award-winning facility helps customers accelerate biologic drug development programs and bring better treatments to help patients live better, healthier lives.
The
Senior Scientist, QC
evaluates the effectiveness of microbial controls necessary to ensure that the manufacturing facility is maintained in a manner that prevents the ingress of microorganisms in low bioburden products, by performing routine and investigational sampling of the manufacturing environment and associated facilities.
This is a full-time, salaried position and is 100% site-based. The schedule is Monday – Friday, 1st shift.
The Role
Independently executes and properly documents cGMP Quality Control testing.
Independently operates basic and moderately complex cGMP Quality Control equipment.
Assists in authoring technical documents such as SOPs and reports.
Enters data into Laboratory Information Management System (LIMS) or laboratory reports.
Performs general lab housekeeping in adherence to 5S standards.
Initiates and assists with records in TrackWise.
Accurately completes routine and preventive maintenance on basic to moderately complex equipment.
Other duties as assigned.
The Candidate
Bachelor’s degree in science field with a minimum of 5 years of experience, including 2 years of GMP experience in a regulated industry; Master’s degree in science field with a minimum of 2 years of experience, including 2 years of GMP experience in a regulated industry; PhD in science field, including 2 years of GMP experience in a regulated industry.
Experience with product testing highly preferred.
Experience with environmental testing highly preferred.
Must be able to read and understand English-written job instructions and safety requirements.
Experience with cGMP, Good Documentation Practices (GDP), or Good Laboratory Practices (GLP) knowledge.
Experience following standard operating procedures (SOP).
Why you should join Catalent
Medical, dental, vision, and wellness benefits are effective on the first day of employment.
Potential for career growth on an expanding team and organization.
152 hours of paid time off annually plus 8 paid holidays.
Engaging Diversity & Inclusion programs including Global Employee Resource Groups.
Community engagement and green initiatives.
Tuition reimbursement program.
Generous 401K match.
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.
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.
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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 is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.
Catalent Biologics in Bloomington, Indiana is a state-of-the-art, GMP manufacturing facility, providing one million sq/ft of drug substance manufacturing, drug product manufacturing, and related pharmaceutical services. This award-winning facility helps customers accelerate biologic drug development programs and bring better treatments to help patients live better, healthier lives.
The
Senior Scientist, QC
evaluates the effectiveness of microbial controls necessary to ensure that the manufacturing facility is maintained in a manner that prevents the ingress of microorganisms in low bioburden products, by performing routine and investigational sampling of the manufacturing environment and associated facilities.
This is a full-time, salaried position and is 100% site-based. The schedule is Monday – Friday, 1st shift.
The Role
Independently executes and properly documents cGMP Quality Control testing.
Independently operates basic and moderately complex cGMP Quality Control equipment.
Assists in authoring technical documents such as SOPs and reports.
Enters data into Laboratory Information Management System (LIMS) or laboratory reports.
Performs general lab housekeeping in adherence to 5S standards.
Initiates and assists with records in TrackWise.
Accurately completes routine and preventive maintenance on basic to moderately complex equipment.
Other duties as assigned.
The Candidate
Bachelor’s degree in science field with a minimum of 5 years of experience, including 2 years of GMP experience in a regulated industry; Master’s degree in science field with a minimum of 2 years of experience, including 2 years of GMP experience in a regulated industry; PhD in science field, including 2 years of GMP experience in a regulated industry.
Experience with product testing highly preferred.
Experience with environmental testing highly preferred.
Must be able to read and understand English-written job instructions and safety requirements.
Experience with cGMP, Good Documentation Practices (GDP), or Good Laboratory Practices (GLP) knowledge.
Experience following standard operating procedures (SOP).
Why you should join Catalent
Medical, dental, vision, and wellness benefits are effective on the first day of employment.
Potential for career growth on an expanding team and organization.
152 hours of paid time off annually plus 8 paid holidays.
Engaging Diversity & Inclusion programs including Global Employee Resource Groups.
Community engagement and green initiatives.
Tuition reimbursement program.
Generous 401K match.
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.
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.
#J-18808-Ljbffr