Process Scientist I

Posted 13 Hours Ago
Be an Early Applicant
Greenville, NC
5-7 Years Experience
Biotech • Pharmaceutical
The Role
The Process Scientist I supports transfer and process development activities by collaborating with teams on GMP batch manufacture and optimization, maintaining inventory, and assisting with documentation for regulatory submissions. Responsibilities include planning development batches, writing SOPs, and maintaining accurate documentation in compliance with GMP guidelines.
Summary Generated by Built In

Process Scientist I

Position Summary

Catalent’s Greenville, N.C. facility specializes in end-to-end turn-key solutions for oral solid dosage forms, including integrated formulation development, analytical services, commercial manufacturing, and packaging. This state-of-the-art facility has had over $100M of investments in recent years and features fit-for-scale capacity with potent handling capabilities, ideal for orphan or targeted drug development. 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 Process Scientist I will assist and support transfer and process development activities. The Process Scientist I will partner with inventory control personnel to help ensure that an adequate inventory of raw materials is maintained at all times.

The Role

  • Provide support in the planning and scheduling of development batches while taking into consideration demand and capacity as well as time requirements and constraints. 

  • Under close supervision, assist development staff in activities related to the manufacture and optimization of suitable processes and GMP batches. 

  • Assist in developing and optimizing suitable processes for commercial scaleup and support transfers of commercial products to the site.

  • Assist with the writing of SOPs, IQ/OQ/PQ documents, development/technical reports, and CMC sections for regulatory submissions as directed. 

  • Collaborate and provide feedback on batch records, protocols, and other technical services documentation. 

  • Ensure that all work is accurate, precise, properly documented and in the case of commercial product, performed within GMP guidelines. 

  • Maintain competence and training documentation for relevant equipment and processes. 

  • Perform any additional assigned tasks including: calibration, analysis, cleaning, facility maintenance, raw material inventory, warehouse operations, etc. 

  • All other duties as assigned.

The Candidate

  • Bachelor’s degree in chemistry, engineering, or related science OR

  • Associate degree in chemistry, engineering, or related science with at least 2 years of relevant pharmaceutical industry experience OR

  • High school diploma or equivalent with at least 5 years of equivalent pharmaceutical industry experience. 

  • Experience with oral solid dosage form manufacturing preferred.

  • Position requires the ability to occasionally lift 40 lbs unassisted, and occasionally push and pull a maximum of 100 lbs.

  • Majority of workday is performed while sitting, standing, and walking. 

  • Requires the use of hands for simple grasping and fine manipulations. 

  • Ability to climb, bend, stoop, twist, and have full range of motion in upper and lower extremities.

  • Occasional exposure to dust, fumes, gases, skin and respiratory irritants, moving machinery parts, and damp, humid and wet environments 

  • This position requires that a respirator be worn for your safety, and as such, employment is contingent upon being able to complete a medical evaluation with satisfactory results. The medical evaluation is conducted via an external vendor assigned by Catalent.

 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. 

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 [email protected]. 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 [email protected] for us to investigate with local authorities.

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

Top Skills

Chemistry
Engineering
The Company
HQ: Somerset, NJ
13,715 Employees
On-site Workplace
Year Founded: 2007

What We Do

Catalent Inc. (NYSE: CTLT), an S&P 500® company, is the global leader in enabling pharma, biotech, and consumer health partners to optimize product development, launch, and full life-cycle supply for patients around the world. With broad and deep scale and expertise in development sciences, delivery technologies, and multi-modality manufacturing, Catalent is a preferred industry partner for personalized medicines, consumer health brand extensions, and blockbuster drugs.

Catalent supports our partners in introducing 200 new products and manufacturing over 70 billion doses each year. Since becoming a publicly traded company in 2014, we have grown to become a community of approximately 19,000+ workers who support over 7,000 products for over 1,000 customers around the world. We share a common goal: to put patients first and help people around the world live better and healthier lives.

Catalyst + Talent. Our name combines these ideas. From drug and biologic development services to delivery technologies to supply solutions, we are the catalyst for your success. We have the deepest expertise, the broadest offerings, and the most innovative technologies to help you get more molecules to market faster, enhance product performance, and provide superior, reliable manufacturing and packaging results.

more products. better treatments. reliably supplied.™

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!

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 life.

Grow with us. Be challenged. Make a personal impact.

Visit https://careers.catalent.com/us/en to explore career opportunities

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