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Catalent Pharma Solutions Analytical Development Specialist in Gaithersburg, Maryland

Job Description

Position Overview:

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 (http://www.catalent.com/index.php/about-us/Catalent-Careers2)

Position Summary

Catalent Gene Therapy (CGT) is a growing Contract Development and Manufacturing Organization (CDMO) with an internationally recognized tradition of quality and service. Catalent Gene Therapy provides process development and GMP manufacturing services for Phase I/II/III clinical trials and Commercial production to industry leaders as well as innovative start-ups utilizing novel technologies to produce state-of-the-art vaccines and therapies for people when they are most in need. As a CGT employee, you will actively contribute to the delivery of our services and products to our customers and their patients.

The Analytical Development Specialist will support Analytical Development by managing equipment and equipment related activities including but limited to equipment procurement, inventory management, maintenance function and software/hardware upgrades. The candidate will also be responsible for supporting department operational needs for training, purchasing and LIMS implementation.

The Role

  • Manage Analytical Development equipment life cycle via Blue Mountain Regulatory Asset Manager (BMRAM) platform

  • Manage and coordinate equipment related projects for the department

  • Assists in the implementation of a Laboratory Information Management System (LIMS) within Analytical Development

  • Review standard test method documentation packages for accuracy and compliance

  • Assists in the writing, reviewing, and editing of standard operating procedures (SOP) and work instructions (WI)

  • Drive the documentation approval process to meet or exceed specified timelines

  • 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

  • Effectively communicate with cross-functional team members such as Process Development, Quality Assurance, Quality Control

The Candidate

  • 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

  • Previous laboratory experience in molecular biology, biochemistry, microscopy, cell culture, sterile technique and related methodologies

  • 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

  • Possesses the knowledge and ability to apply basic scientific and regulatory principles to solve operational, as well as routine quality tasks

Catalent’s standard leadership competencies that are used to interview and for Performance & Development

  • Leads with Integrity and Respect

  • Delivers Results

  • Demonstrates Business Acumen

  • Fosters Collaboration and Teamwork

  • Champions Change

  • Engages and Inspires

  • Coaches and Develops

Position Benefits

  • 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

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 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 (https://catalent.wd1.myworkdayjobs.com/External) 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 (https://www.youtube.com/playlist?list=PLuUGqEwwnH7hBwFlrsfSOH_raQHu4hOBK) .

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