Process Development Engineer

Process Development Engineer I

Position Summary:

• Work Schedule: Monday - Friday from 8am-5pm, overtime as needed depending on production

• 100% on-site (Chelsea, MA)

Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO), and the Boston-area facility is Catalent's global Center of Excellence for spray dry dispersion and Dry Powder Inhaler (DPI) capsule manufacture and packaging. The site features inhaled powder spray drying, as well as multiple commercial-scale lines for capsule filling and blister packaging. On-site spray dryers include best-in-class GEA Niro SD1, SD4 and SD7, the latter being the largest CGMP unit of its kind for DPI in North America.

Catalent Pharma Solutions is hiring a Process Development Engineer who will actively participate in the development of pharmaceutical processes, technology transfers and scale-up of spray-drying, secondary drying, capsule filling, and capsule blistering processes. You will support Good Manufacturing Practices (GMP) clinical and non-GMP development manufacturing, particularly for dry-powder inhalation products. This person is also responsible for transferring the process to commercial manufacturing and providing recommendations for a successful scale-up and transfer. You will be a key member of troubleshooting manufacturing issues at any stage of development.

The Role:

• 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

The Candidate:

• Bachelor's Degree in Chemical, Biomedical Engineering or Pharmaceutical Sciences (or related field) required. Master's Degree is a plus

• Must have at least one (1) year of relevant industry experience (defined below), 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. Minitab or JMP is a plus

• 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

Pay:

• The anticipated salary range for this role in Massachusetts is $69,300,000 to $100,000 annually. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states.

Why you should join Catalent:

• 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

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 ( .