Catalent · 12 hours ago
Process Development Engineer
Chelsea, MA
Full-time
Onsite
Entry Level
1+ years expCatalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO), and they are seeking a Process Development Engineer. This role involves participating in the development of pharmaceutical processes, technology transfers, and scale-up of spray-drying and capsule filling processes, while supporting Good Manufacturing Practices (GMP) manufacturing.
BiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
Responsible for the start-up, troubleshooting and process development of late phase tech transfer, scale-up and pre-commercial manufacturing
Supports process development activities and is responsible to set-up and run experiments on GMP manufacturing equipment
Conducts analysis of development data and provides recommendations for future experimental designs
Participates in the assembly, operation, disassembly and cleaning of equipment. Assists manufacturing operations with validation of new processes as needed
Responsible for the evaluation of critical process data and drives the process development life-cycle
Provide technical support to other areas including spray drying, secondary drying, process engineering, QC, and QA
Understand Quality by Design approaches and conduct modeling exercises to better understand process development. Manages and coordinates individual projects (internal and external) as needed
All other duties as assigned
Qualification
Required
Bachelor's Degree in Chemical, Biomedical Engineering or Pharmaceutical Sciences (or related field) required
Must have at least one (1) year of relevant industry experience, preferably in biotechnology/pharmaceutical R&D
Prior experience with dry powders for inhalation, specifically in the areas of particle engineering of dry powders, blending and capsule filling
Strong statistical background with knowledge of Design of Experiments (DoE) preferred
Knowledge of Quality by Design, cGMP and modelling is a plus
Must be proficient in Microsoft Office Suite
Ability to effectively manage time and prioritize tasks independently to meet tight timelines and shifting priorities
Physical requirements: Individual may be required to sit, stand, walk regularly and occasionally lift 0-40 pounds
Preferred
Master's Degree is a plus
Strong statistical background with knowledge of Design of Experiments (DoE) preferred
Knowledge of Quality by Design, cGMP and modelling is a plus
Minitab or JMP is a plus
Benefits
Defined career path and annual performance review and feedback process
Diverse, inclusive culture
Positive working environment focusing on continually improving processes to remain innovative
Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
152 Hours + 8 paid holidays
Several Employee Resource Groups focusing on D&I
Dynamic, fast-paced work environment
Community engagement and green initiatives
Generous 401K match
Company match on donations to organizations
Medical, dental and vision benefits effective day one of employment
Tuition Reimbursement – Let us help you finish your degree or start a new degree!
WellHub program to promote overall physical wellness
Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories
Company
Catalent
Catalent - Blow-Fill-Seal Sterile CDMO Business is focusing on complex clinical to commercial stage formulation and manufacturing. It is a sub-organization of Catalent Pharma Solutions.
10001+ employees
H1B Sponsorship
Catalent has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (1)
Funding
Current Stage
Late StageTotal Funding
unknown2021-01-06Acquired
Leadership Team
Alessandro Maselli
President & Chief Executive Officer
Charles Lickfold
Senior Vice President, Chief Information Officer
Recent News
2026-01-22
Company data provided by crunchbase