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Form of work The Microbiologist III will perform microbiological method development and verification, testing of raw materials and sterile and non-sterile pharmaceutical dosage forms, and general support activities within the Microbiology group. An individual in this role functions as a microbiology technical lead, interacts with external and internal customers for project support, and mentors or provides technical guidance to junior analysts. Responsibilities also include coordinating, performing and/or supporting instrument/equipment qualification activities, as well as associated maintenance and calibration programs. The Microbiologist III will author and/or revise procedures/methods, as appropriate.
The Microbiology and Environmental Monitoring groups at Catalent Morrisville are responsible for the microbial testing support for internal and external customers including Catalent sister sites. The microbiology team performs microbiology testing (sterility, microbial limits, endotoxin testing, etc.) for API, Finished Product, Stability, Raw Materials and Components. The Environmental Monitoring team performs microbiology testing (TOC, conductivity, bioburden, etc.) supporting onsite utilities and manufacturing environments.
The Role
Develop and execute laboratory work plans/schedules independently, using customer milestones and Division/site performance standards and metrics.
Authors technical documents, such as protocols, test methods, text reports, certificates of analysis, operating procedures and investigations.
Review technical documents for accuracy, thoroughness and regulatory compliance.
Trains, coaches or mentors others on technical, personal development or business issues.
Responsible as Project Director with responsibility for project outcome and customer interaction.
Executes efficiency improvement project with guidance.
Identify and recommend business opportunities on a project specific basis.
All other duties as assigned.
The Candidate
Doctoral degree, Masters degree, Bachelors degree, or Associates degree in chemistry or closely related physical science from a four-year college/university or equivalent education and training.
PhD and 0 years related experience OR MS and 4 years related experience OR BS and 7 years related experience, or equivalent education, experience and training.
Maintain high quality laboratory documentation in accordance with applicable regulatory guidance and Site SOPs.
Develop and execute complex procedures or methods of moderate complexity with high quality.
Propose deviations from established procedures and methods based upon sound judgment.
Supervisory skills are expected for Scientists with direct reports.
On an average 8-hour day this position requires the ability to walk, sit and stand, use hands to handle or feel, reach with hands and arms at or above shoulder height and below waist height, climb or balance, stoop, kneel, crouch, or crawl; talk and hear, smell and lift up to 40 pounds.
Specific vision requirements including reading of written documents, visual inspection of materials and use of computer monitor screen frequently.
May require the use of a respirator.
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.
The Microbiology and Environmental Monitoring groups at Catalent Morrisville are responsible for the microbial testing support for internal and external customers including Catalent sister sites. The microbiology team performs microbiology testing (sterility, microbial limits, endotoxin testing, etc.) for API, Finished Product, Stability, Raw Materials and Components. The Environmental Monitoring team performs microbiology testing (TOC, conductivity, bioburden, etc.) supporting onsite utilities and manufacturing environments.
The Role
Develop and execute laboratory work plans/schedules independently, using customer milestones and Division/site performance standards and metrics.
Authors technical documents, such as protocols, test methods, text reports, certificates of analysis, operating procedures and investigations.
Review technical documents for accuracy, thoroughness and regulatory compliance.
Trains, coaches or mentors others on technical, personal development or business issues.
Responsible as Project Director with responsibility for project outcome and customer interaction.
Executes efficiency improvement project with guidance.
Identify and recommend business opportunities on a project specific basis.
All other duties as assigned.
The Candidate
Doctoral degree, Masters degree, Bachelors degree, or Associates degree in chemistry or closely related physical science from a four-year college/university or equivalent education and training.
PhD and 0 years related experience OR MS and 4 years related experience OR BS and 7 years related experience, or equivalent education, experience and training.
Maintain high quality laboratory documentation in accordance with applicable regulatory guidance and Site SOPs.
Develop and execute complex procedures or methods of moderate complexity with high quality.
Propose deviations from established procedures and methods based upon sound judgment.
Supervisory skills are expected for Scientists with direct reports.
On an average 8-hour day this position requires the ability to walk, sit and stand, use hands to handle or feel, reach with hands and arms at or above shoulder height and below waist height, climb or balance, stoop, kneel, crouch, or crawl; talk and hear, smell and lift up to 40 pounds.
Specific vision requirements including reading of written documents, visual inspection of materials and use of computer monitor screen frequently.
May require the use of a respirator.
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.
