Catalent Pharma Solutions Associate Scientist II – Analytical Development Operations in Gaithersburg, Maryland
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 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. Interested in learning more about life at Catalent? Start here
Catalent Gene Therapy is looking to recruit an Associate Scientist II – Analytical Development Operations to join our growing team in Gaithersburg, MD
The Associate Scientist II will support Analytical Development by reviewing standard test method documentation packages that are compiled by the scientific team members for accuracy and compliance. This role is critical to the success of the Analytical Development team as it will increase efficiency within the team and cross functionally. The candidate will also assist in the management of Critical Reagents and Reference Standards for Analytical Development and Quality Control use (generation, qualification, and stability monitoring) and supporting department operational needs (training, purchasing, inventory management).
Perform reagent qualification testing using ELISA based and enzymatic assays, BCA, SDS-PAGE and Western blot and other analytical methods when required.
Review standard test method documentation packages for accuracy and compliance
Use knowledge of cell-based assays, protein characterization assays, enzymatic based assays such as ELISA, and instrument-based methods such as HPLC, ddPCR, and PCR to provide support to the contents of document packages as needed.
Assist in Critical Reagent and Reference Standard inventory management which includes the preparation, aliquoting, and distribution of materials.
Analyze analytical data related to Critical Reagent and Reference Standard characterization, qualification, and stability monitoring.
Assist in the writing, reviewing, and editing of standard operating procedures (SOP), COTs and reagent qualification protocols and reports.
B.S. in Biology, Chemistry, Life Sciences or related field and 5-8 years of industry experience
M.S. in Biology, Chemistry, Life Sciences or related field and 3-5 years of industry experience
Hands on experience with ELISA, SDS-PAGE, Western Blot, BCA assays, HPLC & ddPCR
Practical experience within the biological, pharmaceutical, or medical device industry performing direct hands-on work in a Quality Assurance/QC function with a strong familiarity of general GMP practices
Previous laboratory experience in molecular biology, biochemistry, microscopy, cell culture, sterile technique and related methodologies
Catalent’s standard leadership competencies that are used to interview and for Performance & Development
Leads with Integrity and Respect
Demonstrates Business Acumen
Fosters Collaboration and Teamwork
Engages and Inspires
Coaches and Develops
Potential for career growth within an expanding team
Defined career path and annual performance review & feedback process
Cross functional exposure to other areas of within the organization
Medical, Dental, Vision, and 401K are all offered from day one of employment
19 days of paid time off annually + 7 paid holidays
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 www.catalent.com/careers to explore career opportunities.
Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation or gender identity. 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.
Catalent = Catalyst + Talent
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!
personal initiative. dynamic pace. meaningful work.
Catalent is the perfect place to grow your career if…
You enjoy the fast pace of a start-up, but want the opportunities and stability of a growing, publicly traded company (Listed on NYSE: CTLT).
You want meaningful work. From cough treatments to cancer-fighting drugs, biologics, and vitamins, we help develop, launch, and supply over 200 new products each year – more than any branded drug maker in the world!
You want to plant your career in a growing company. Over the last five years, Catalent has re-invested more than $2 billion back into the company and its people.
You are excited about learning, collaborating, and growing alongside a global diverse team. Our team of more than 11,000 comes to work every day ready to overcome new challenges with teamwork, advanced technologies, and a passion to deliver by putting patients first.
You want to make a global impact! From North America to Europe, Asia to Latin America, we have innovative science and manufacturing teams who are looking for YOU!
See how our teams are making a difference, while growing their careers and fulfilling our mission by putting patients first every day here.
Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status. 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 along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.