Catalent Pharma Solutions MS&T Engineer III in Harmans, 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 (http://www.catalent.com/index.php/about-us/Catalent-Careers2)
The Manufacturing Sciences & Technology (MS&T) Engineer III will support Manufacturing Operations in the successful transfer and startup of clinical drug substance and drug product cGMP manufacturing operations at Catalent Gene Therapy. The MS&T Engineer III is actively engaged in the technical transfer of client and Catalent Process Development information for implementation of cGMP processes. The individual will serve as a subject matter expert (SME) for biologic Upstream Processes and/or Downstream Processes. Success in this position requires the ability to work hands on in a cleanroom, and the ability to collaborate in a cross-functional, fast paced environment.
The MS&T Engineer III role is critical to our patients. The Engineer III in MS&T is responsible for accurately transferring the process from the client and process development to manufacturing with patient safety in mind, executing with efficiency always. Quality, safety and on-time delivery is a must to be successful in this role!
Work with GMP manufacturing and Process Development in one or more of the following areas: cell culture, purification and/or fill & finish
Support client projects as the MS&T Lead for tech transfer of projects from Paragon Process Development and external clients into GMP manufacturing.
Author tech transfer documents, including detailed process descriptions and scale-up documents
Author Master Production Records and SOPs to support GMP manufacturing projects
Working closely with project management to ensure MS&T project milestones are achieved
Collect and trend process data for external (client) and internal review, and for support of client needs.
With support of senior staff, draft and/or author technical reports, process tech transfer summary reports, and protocols in support of Tech Transfer and cGMP activities
Assist with training GMP Manufacturing staff on Client processes
Serve as team leader for process and product investigations and author investigation reports
Evaluate and recommend equipment for client projects
B.S. Chemical Engineering, Chemistry, Biology, Life Sciences or related field with 6+ years of experience in the pharmaceutical or biotechnology industry -OR-
M.S. Chemical Engineering, Chemistry, Biology, Life Sciences or related field with 2+ years of experience
Knowledge/expertise relevant to protein and virus manufacturing in a cGMP environment.
Experience in one or more of the following manufacturing areas: cell and/or microbial culture, protein purification and fill/finish
Experience in a CMO environment or in a similar client-customer based work environment a plus
Key leadership attributes
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 + 8 paid holidays
Gain experience in the cutting-edge gene therapy space
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) .