Associate Scientist Iii/Scientific Writer, Upstream Process Development

Associate Scientist III/Scientific Writer, Upstream Process
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 - III clinical trials and commercial products. Catalent Maryland provides gene therapy and viral vector-based therapies 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.
This is a full- time, salaried, position: Monday - Friday, 8:00 am - 5:00 pm.
The Process Development Department is responsible for upstream and downstream Process Development, pilot scale execution, and tech transfer of developed processes to MS&T for GMP manufacturing.
This individual is actively involved in various projects and performs independently and productively as an Upstream Development Scientist/Scientific Writer within a dynamic project team. Develops comprehensive documentation that meets organizational standards. Provides technical support in preparing the Upstream PD documentation. Displays strong technical knowledge, initiative, and scientific commitment and makes significant scientific and technical contributions within the Process Development Group. Maintains openness to understanding areas outside of primary function to foster continuous improvement.
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:

• Participates in client projects starting from the development and optimization toward cGMP manufacturing for clinical trials, registration, or improvements of existing processes and products.
• Collects information from subject-matter experts and, working closely with various departments, assists Upstream PD in writing and editing the content of the reports, procedure descriptions, and other process documentation.
• Assists MS&T in preparing the documents for transferring the production processes from PD to cGMP manufacturing.
• Participates 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 field in Chemical Engineering, Biochemical Engineering, Chemistry, or Life Science field (MS with 2+ years of experience or BS with 5+ years of experience)
• Upstream Process Development experience specific to protein/VLP/viral vector production (AAV, lentivirus) preferred.
• Knowledge and experience working with Single-Use bioreactor systems for bioprocessing at different scales, from benchtop to large-scale bioreactors preferred.
• Experience with harvest systems - centrifugation, filtration (depth and sterile) preferred.
• Ability to handle multiple projects simultaneously, quickly learn and understand complex subject matter.
• Proven record in writing documentation and procedure manuals, data interpretation and analysis, and preparation of reports and presentations. Knowledge of statistical analysis is a plus (JMP, Minitab, etc.) and good communication skills.

• Experience with editing, improving, and refining the content of the documents and creating visuals and diagrams for technical support content.

• Understanding Design of Experiment and Quality by Design concepts is a plus.
• The ability to work in a team-oriented environment is essential, as this person will work closely with the Process Development team, MS&T, and Operations.
• Experience with Good Manufacturing Practices (GMP) is a plus.

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:
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