Scientist, Upstream Process Development

Position Summary:   

Catalent Maryland Inc is a growing Biotech Contract Development and Manufacturing Organization (CDMO) with an internationally recognized tradition of quality and service. Catalent provides process development and GMP manufacturing services for Phase I/II clinical trials 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 Catalent employee, you will actively contribute to delivering our services and products to customers and their patients.

The Process Development Department is responsible for upstream and downstream process development, pilot scale execution, and tech transfer of developed processes to GMP manufacturing.   

This is a full- time, salaried, position:  Monday – Friday, 8:00 am – 5:00 pm.

This individual performs independently and productively as an Upstream Development Scientist and actively engages in process and product development within a dynamic project team. Displays strong technical knowledge, initiative, and scientific commitment and makes significant scientific and technical contributions within the Process Development Group.

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:  

• Lead client projects starting from the development and optimization toward cGMP manufacturing for clinical trials, registration, or improvements of existing processes and products.
• Interact and collaborate with clients regarding the Upstream activities of the program, including the design and execution of the experiments, analysis, and presentation of the experimental results.
• Act as subject matter expert in Upstream Process Development of biologics including, but not limited to vaccines, viral vectors, and recombinant proteins.
• Development and execution of large-scale (50 – 200 liter) productions and harvest protocols. Utilizes technical knowledge to scale up to manufacturing scales.
• Assist MS&T in preparing the documents for transferring the production processes from PD to cGMP manufacturing.  Provide technical support in engineering and GMPs runs.
• Lead and participate in project team decision-making processes by actively engaging in scientific and technical discussions.
• Expands the technical capabilities of the Process Development group by offering expertise in areas such as technology development, platform, or systems development, or using a literature precedent.
• Other duties as assigned.

The Candidate:  

• Degree in Chemical Engineering, Biochemical Engineering, Chemistry, or Life Science field. (Ph.D. with 1+ year; MS with 3+ years; BS with 4+ years’ experience)
• Upstream process development experience specific to protein/virus purification/bacteriophages.
• Experience with Good Manufacturing Practices (GMP).
• Excellent aseptic cell culture technique and analytical methods relevant to bioprocessing.
• Knowledge and experience working with Single-Use bioreactor systems for bioprocessing at different scales, from benchtop to large-scale bioreactors.
• Extensive experience in cell culture, both adherent and suspension, with transfection for recombinant protein production.
• Understanding Design of Experiment and Quality by Design concepts is a plus.
• Experience with harvest systems – centrifugation, filtration (depth and sterile).
• The ability to work in a team-oriented environment is essential, as this person will work closely with MS&T and Operations and should be able to lead a group of associate scientists to complete the projects successfully.  

Why you should join Catalent:

• Defined career path and annual performance review and feedback process.
• Diverse, inclusive culture.
• Potential for career growth on an expanding team.
• Cross-functional exposure to other areas within the organization.
• 152 hours of paid time off annually + 8 paid holidays.
• Medical, dental, vision and 401K benefits effective day one of employment.
• Employee Stock Purchase Plan.
• Tuition Reimbursement.

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 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 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.

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 spam@catalent.com for us to investigate with local authorities.

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