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Manufacturing Associate ll

Catalent Pharma Solutions

This is a Contract position in Toronto, ON posted November 17, 2022.

The Manufacturing Associate ll is responsible for supporting the overall GMP manufacturing process while adhering to Standard Operating Procedures in a controlled Clean Room environment and following cGMP guidelines and FDA standards and safety regulations.

Catalent Cell & Gene Therapy hires people with a passion to make a difference.

Your expertise, coupled with our advanced technologies and collaboration with 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.

The role: Perform and support all manufacturing for both clinical and commercial activities that meet the site’s strategic objectives and is compliant with cGMP’s, safety regulations, and FDA standards.

Completes Batch Production Records under cGMP, and documents in detail using SOPs and BPRs for the processes and manufacturing steps.

Collaborate with the Process Development and Manufacturing Sciences and Technology (MSAT) group to transfer new projects into GMP.

Identify, communicate, and implement process improvements.

Generate and revise internal and external documents (SOPs, Batch Records) Assist in the initiations and closures of deviations and CAPAs as well as in departmental investigations.

Troubleshoot processing and equipment issues.

Work with Facilities and Validation to ensure proper functionality of equipment.

Work closely with Supervisors and CTS III’s for current and new manufacturing projects.

Assist with processes/techniques to meet contract objectives in a timely manner.

The candidate: Experience working with Biologics and/or Cell Therapy (i.e., CAR-T, CRISPR, etc.…) and prior experience working in a clean room environment is strongly preferred.

Experience working under pressure meeting timelines.

Effective communication skills both verbally and written.

Proficiency in English (verbal and written) is required.

Be able to work in clean room with aseptic gowning for long periods of time.

Proficient in MS Office applications (Word, Excel, PowerPoint, and Outlook) and basic mathematical skills.

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 DisabilityAccommodationscatalent.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 spamcatalent.com for us to investigate with local authorities.