Location: Harmans,MD, USA
Associate 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 Associate 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, compliance to regulations and standards in the subject of sterility assurance and contamination control. The Associate Scientist will work both independently and with the team to perform routine and non-routine microbiological testing, environmental monitoring, and/or microbiology laboratory maintenance functions, where necessary.
This position is 1st shift M-F 8AM-5PM and 100% on site at Harmans/BWI, Maryland 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.
* 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; conducts sampling and testing of utilities such as USP water, WFI, clean steam, and CCA/Gas.
* Maintain the Micro labs in a state of audit readiness; ensure daily or weekly maintenance of all Micro laboratory instrumentation and media usage dates; provide accurate product, raw material, and Environmental monitoring microanalysis data.
* Perform Bacterial Endotoxin testing using the kinetic chromogenic method; perform bioburden testing using membrane filtration for cleaning, in-process, buffer/media, and release samples; perform growth promotion of microbiological media; perform microbial isolation techniques, subculturing, and gram stain identifications.
* Send out samples to contract labs and track results/reports; perform general laboratory cleaning/wipe-down; maintain lab inventory and partner with management to request order lab supplies and materials to be ordered.
* Support continuous improvement projects related to QC; support the revision of controlled documents such as Standard Operating Procedures and controlled forms; assist with investigations, change controls, and CAPAs associated with microbiological testing; support data trending and tracking of results.
* Communicate effectively with QC peers, cross-functional peers, and management; actively participate in training activities and managing individual training plan.
* Other duties as assigned.
The Role:
* Bachelor in a Microbiology, Biology, or related discipline required with experience working in a cGMP QC laboratory preferred.
* Knowledge of cGMP, familiarity with Quality Tools such as SPC and Root Cause Analysis, FMEA, HACCP, and technical writing skills.
* Demonstrate knowledge of scientific understanding of microbiological methods; demonstrated ability to investigate and identify causes of suspect laboratory results; comfortable working in cleanroom and BSC environments in aseptic gowning for extended periods of time.
* Experience in technical writing 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.
The anticipated salary range for this position in Maryland is $58,240-$80,080
plus annual bonus, when eligible. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states.
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 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 ...@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.
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