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Sr. Scientist, QC Microbiology

Employer
Catalent
Location
Harmans, Maryland, US
Salary
Competitive
Closing date
Dec 7, 2022

View more

Sector
Consultancy/Private Sector
Field
Conservation science
Discipline
Biology
Salary Type
Salary
Employment Type
Full time
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Sr. QC Scientist - Microbiology

Catalent 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/Job Duties:
  • Perform microbiological testing for buffers/solutions, in-process manufacturing samples, bulk drug substance and finished drug product samples.
  • Develop and perform validation testing of microbiological methods for client specific products and materials.
  • Draft, review and revise microbiological procedures. Document writing, data interpretation, results presentation, statistical analyses, and trending.
  • Assist in developing a microbial contamination control plan and program, with a focus on sterility assurance and manufacturing drug products under controlled conditions.
  • Assist in the tracking, trending, and identification of all facility microorganisms including cataloging and generating stock of facilities resident microflora.
  • Evaluate manufacturing processes for potential to eliminate and limit bioburden (for example, HACCP or FEMA approach) as well as reviewing cleaning steps, equipment hold times, HVAC, control level of environments for critical tasks, open-system vs closed-system operations, and bioburden monitoring.
  • Perform cleaning and disinfection validation studies as wells as minimization of cleaning material residual control.
  • Ensures that raw materials, components, products, or monitoring results that do not meet specifications or expectations are promptly investigated. Identifies possible source and corrective action needed and evaluates the impact upon the product.
  • Identifies adverse microbial quality trends by preparing and analyzing Environmental Monitoring summary reports.
  • Reviews work performed by department staff for accuracy, completeness and conformance to GDP and product specifications.
  • Mentors and develops new department personnel including training in Standard Operating Procedures and On The Job Training (OJT).
  • Assures department is equipped with functional, calibrated equipment and necessary supplies.
  • Investigates and resolves non-conforming test results by completing thorough Deviation, OOS/OOT, and Laboratory Investigation Reports
  • Represents the QC Microbiology department in cross functional teams and internal/external meetings.
  • Assumes other duties and responsibilities as assigned.


SUPERVISION:
  • Minimum to no supervision required on day-to-day activities and assigned tasks
  • Escalates problems and factors impacting work performance or completion of assigned tasks to the area manager along with corrective action plans to resolve identified issues.


Experience & Education:
  • BS or BA in Microbiology, Biological sciences, or related fields experience.
  • 5+ years of experience and knowledge in the pharmaceutical and/or biotech industry in sampling and testing of critical utilities and environmental monitoring within a GMP environment.
  • Extensive experience performing USP testing such as bioburden, growth promotion, endotoxin, TOC and conductivity.
  • Must possess strong aseptic technique experience and must be able to gown as required in Aseptic Manufacturing areas.
  • Advanced knowledge of cGMPs, safety, proper documentation, and data integrity.
  • Knowledge and application of GMP principles and working in an FDA regulated environment.
  • Strong communication skills: oral/written and listening.


We will identify candidates based on the following:
  • Leads with Integrity and Respect
  • Delivers Results
  • Demonstrates Business Acumen
  • Fosters Collaboration and Teamwork
  • Champions Change
  • Engages and Inspires
  • Coaches and Develops


Position Benefits:
  • Join a high growth and fast paced organization with a people focused culture
  • Global exposure, defined career path and annual performance review and feedback process
  • Competitive Medical, Dental, Vision and 401K


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.
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