Associate Scientist, QC Micro

Posted 17 Days Ago
Be an Early Applicant
Hanover, MD
58K-80K Annually
Entry level
Biotech • Pharmaceutical
The Role
The Associate Scientist in QC Microbiology will assist with contamination control and sterility assurance for aseptic production, perform microbiological testing, and ensure compliance with relevant regulations. Responsibilities include environmental monitoring, maintaining laboratory instrumentation, performing testing such as Bacterial Endotoxin and bioburden testing, and supporting QC improvement projects.
Summary Generated by Built In

Associate Scientist, QC Microbiology

Position Summary

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

 The Associate Scientist 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 3rd shift Monday-Friday 12AM-8AM and 100% on site at the Harmans/BWI, MD facility.


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.


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 [email protected]. 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 [email protected] for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.

The Company
HQ: Somerset, NJ
13,715 Employees
On-site Workplace
Year Founded: 2007

What We Do

Catalent Inc. (NYSE: CTLT), an S&P 500® company, is the global leader in enabling pharma, biotech, and consumer health partners to optimize product development, launch, and full life-cycle supply for patients around the world. With broad and deep scale and expertise in development sciences, delivery technologies, and multi-modality manufacturing, Catalent is a preferred industry partner for personalized medicines, consumer health brand extensions, and blockbuster drugs.

Catalent supports our partners in introducing 200 new products and manufacturing over 70 billion doses each year. Since becoming a publicly traded company in 2014, we have grown to become a community of approximately 19,000+ workers who support over 7,000 products for over 1,000 customers around the world. We share a common goal: to put patients first and help people around the world live better and healthier lives.

Catalyst + Talent. Our name combines these ideas. From drug and biologic development services to delivery technologies to supply solutions, we are the catalyst for your success. We have the deepest expertise, the broadest offerings, and the most innovative technologies to help you get more molecules to market faster, enhance product performance, and provide superior, reliable manufacturing and packaging results.

more products. better treatments. reliably supplied.™

Your talents, ideas, and passion are essential to our mission: to develop, manufacture, and supply products that help people live better, healthier lives. Join us!

Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent’s advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech, and healthcare companies, will help bring life-enhancing products to life.

Grow with us. Be challenged. Make a personal impact.

Visit https://careers.catalent.com/us/en to explore career opportunities

Similar Jobs

BAE Systems, Inc. Logo BAE Systems, Inc.

SIGINT Analyst - Level 3

Aerospace • Hardware • Information Technology • Security • Software • Cybersecurity • Defense
Hybrid
Fort Meade, MD, USA
40000 Employees
127K-215K Annually

BAE Systems, Inc. Logo BAE Systems, Inc.

SIGINT Analyst - Level 2

Aerospace • Hardware • Information Technology • Security • Software • Cybersecurity • Defense
Hybrid
Fort Meade, MD, USA
40000 Employees
112K-191K Annually

Ahold Delhaize USA Logo Ahold Delhaize USA

Analyst II Planning

AdTech • eCommerce • Food • Marketing Tech • Retail
Hyattsville, MD, USA
10000 Employees

Ahold Delhaize USA Logo Ahold Delhaize USA

Process Excellence Analyst II

AdTech • eCommerce • Food • Marketing Tech • Retail
Hyattsville, MD, USA
10000 Employees

Similar Companies Hiring

Novo Nordisk Thumbnail
Software • Pharmaceutical • Healthtech
Bagsværd, DK
69000 Employees
Zealthy Thumbnail
Telehealth • Social Impact • Pharmaceutical • Healthtech
New York City, NY
13 Employees
Cencora Thumbnail
Pharmaceutical • Logistics • Healthtech
Conshohocken, PA
46000 Employees

Sign up now Access later

Create Free Account

Please log in or sign up to report this job.

Create Free Account