Associate Scientist, Manufacturing Science and Technology

Catalent Cell & Gene Therapy is a growing 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 the delivery of our services and products to our customers and their patients.
The MS&T Associate Scientist is responsible to support activities for technology transfer (new product introductions and process improvements) into Manufacturing.
In addition, the MS&T Associate Scientist understand manufacturing and production technology to effectively collaborate in the identification of relevant observations that lead to successful process and/or technology introduction to the production facility.
This role requires direct support to process control strategy development, technical supporting studies that bring process robustness and consistency.
This position requires interaction with Client, Process Development, Manufacturing, and Quality to ensure successful implementation of cGMP drug substance and drug product manufacturing processes.
This is a fulltime position working Days; Monday – Friday 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: Supports scale-up and technology transfer of manufacturing processes to commercial facility process performance monitoring; implementation of process improvement strategies; and development of process models.
Owns projects of low to medium complexity assigned by supervisor who is a higher-level scientist or manager.
Prepares detailed technical reports summaries, data analytics, quantitative analyses, and maintains appropriate documentation.
Authors technical assessments and/or reports.
Assists preparation of complex documents such as sample plans, campaign summary reports, facility fit and other site-specific process reports.
Provides technical assessments in support of change controls, supplier change notifications and other quality records with supervision.
Presents technical approaches, scientific findings and/or recommendations at internal interdisciplinary meetings, and may present at external scientific meetings Understands process trends, assists process performance improvement initiatives, and executes investigations to resolve deviations.
Might assist in the training of manufacturing staff and/or personnel from other disciplines.
Could supports audits or regulatory inspections, provides inputs for regulatory documents.
Possesses knowledge on one or several process unit operations within the manufacturing process (upstream, downstream, fill/pack, or shipping).
Working closely with project management to ensure MS&T project milestones are achieved Other duties as assigned.
The Candidate: Masters’ degree in a Scientific, Engineering or Biotech field with 1 – 3 years’ experience in cGMP production &/or Process Development, with knowledge and understanding of process, documentation requirements and activities.
OR Bachelor’s degree in a Scientific, Engineering or Biotech field with 2 - 5 years’ experience in cGMP production &/or Process Development, with knowledge and understanding of process, documentation requirements and activities.
Demonstrated experience in leading and participating in process scale-up, technical transfers.
Demonstrate intermediate understanding of site quality GxP systems supporting document management, change controls, deviations, CAPAs.
Prior experience in lab and manufacturing settings along with change control experience with both Process and Analytical changes will be a plus.
Knowledge of GMP’s, FDA regulations and documentation procedures required.
Experience in quality systems regulations.
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 Creative thinking with the ability to multi-task.
Commitment to ongoing professional development.
Team player who thrives in collaborative environments and revels in team success.
Solid communication skills across technical and non-technical audiences and the ability to create and communicate complex concepts and analyses in easy-to-understand ways.
Why You Should Join Catalent Competitive medical benefits and 401K 152 hours of PTO + 8 Paid Holidays Dynamic, fast-paced work environment Opportunity to work on Continuous Improvement Processes 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.