Scientist, QC Microbiology

Scientist, QC Microbiology

Position 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 Harmans/BWI, MD facility is a FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies. The campus features two manufacturing facilities: The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq. ft., houses 10 CGMP manufacturing suites, fill/finish, central services, testing labs, and a warehouse. The Harmans/BWI-2 facility, at approximately 145,000 sq. ft., is under development and will house 8 CGMP manufacturing suites and cold storage warehousing. Both facilities support Phase 3 through commercial manufacturing of advanced therapeutic products including AAV and other viral vector-based therapies and vaccines.

The Scientist, QC Microbiology will assist with the end-to-end contamination control and sterility assurance practices for Catalent’s aseptic production process. This position will support the following areas: Aseptic processing, cleaning and disinfection process, microbiological testing, environmental control and monitoring, and compliance to regulations and standards in the subject of sterility assurance and contamination control. The Scientist will work both independently and with the team to perform routine and non-routine microbiological testing, environmental monitoring, and/or and microbiology laboratory maintenance functions, where necessary.

This position is 1st shift M-F and 100% on site at our BWI/Harmans, MD facility.

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:

• Ensure testing compliance meets the requirements of ISO, USP, EU, CFR, cGMP, and GLP, in the Microbiology laboratory at all times; document laboratory test results utilizing Good Documentation Practices; conduct sampling and testing of utilities such as USP, WFI water, clean steam, and CCA/Gas.

• Maintain the Micro labs in a state of audit readiness; maintain a working knowledge of all Micro laboratory instrumentation used for testing and EM procedures; provide accurate product, raw material, and Environmental monitoring data.

• Perform peer review for Micro results and media plate reads for other Microbiologists, ensuring current results and reports meet SOP and protocol requirements.

• Perform Bacterial Endotoxin testing using the kinetic chromogenic method; perform routine and in-process environmental monitoring in Grades A, B, C, and D environments, including areas where full aseptic gowning is worn for extended periods of time.

• Perform growth promotion testing of microbiological media; perform microbial isolation techniques, subculturing, and Gram stain identifications; perform bioburden testing using membrane filtration for cleaning, in-process, buffer/media, and release samples.

• Support continuous improvement projects related to QC; assist with input for revision and creation of controlled documents such as Standard Operating Procedures and controlled forms. Author non-routine protocols/validation plans/reports in support of projects; assist with investigations, change controls, and CAPAs associated with microbiological testing; may assist QC Manager/Supervisor with GMP and safety training of Quality Control staff.

• Perform general laboratory cleaning/wipe-down; perform routine maintenance of lab equipment and maintain lab inventory.

• Support data trending and tracking of results; provide training to all Microbiologists on new and existing revisions to laboratory methods and work instructions; actively participate in training activities and managing individual training plan; communicate effectively with QC peers, cross-functional peers, and management.

• Other duties as assigned.

The Candidate:

Bachelor in a Microbiology, Biology, or related discipline with 2 years of experience working in a cGMP QC laboratory OR Masters in a Microbiology, Biology, or related discipline with experience working in a cGMP QC laboratory preferred.

Experience working in cGMP Quality Control; experience in cGMP environment and experience with Quality Tools such as SPC and Root Cause Analysis, FMEA, HACCP, and technical writing skills.

Test method development and validation of various bioassay and microbiological or chemical test attributes experience; demonstrate strong scientific understanding of microbiological methods; strong knowledge of microbiological method design.

Comfortable working in cleanroom and BSC environments in aseptic gowning for extended periods of time; demonstrated ability to investigate and identify causes of suspect laboratory results.

Strong technical writing skills and use of Microsoft Office products.

Strong attention to detail and strong organizational skills; strong verbal communication skills with internal teams and outside contract laboratories; ability to succeed in a team-oriented environment under very dynamic conditions.

Must have the ability to work an available set shift. There will be times when overtime is required.

Why you should join Catalent:

Defined career path and annual performance review and feedback process

Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives

Dynamic, fast-paced work environment

Generous 401K match and Paid Time Off accrual

Medical, dental and vision benefits effective day one of employment

Tuition Reimbursement

Wellhub program to promote overall physical wellness

Perkspot – offers exclusive or private discounts from approximately 900 merchants in a wide array of categories

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 (https://careers.catalent.com/us/en) 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.

California Job Seekers can find our California Job Applicant Notice HERE (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .