Job Title: Product Development Scientist

Job Description

We are seeking an experienced Product Development and Formulation Scientist to develop and optimize pharmaceutical products. This role involves identifying and evaluating new technologies and formulation processes, preparing development plans, and ensuring compliance with cGMP, FDA, and EMA regulations.

Responsibilities

• Lead and support the development of novel dosage forms and manufacturing processes for the delivery of drugs.
• Prepare formulation development plans to meet project timelines.
• Utilize Quality by Design (QbD) and Design of Experiments (DOE) approaches to control critical factors affecting product quality.
• Collaborate with the global product development team to prepare, execute, and evaluate stability of various product dosage forms.
• Troubleshoot manufacturing processes and suggest improvements.
• Prepare and authorize manufacturing protocols, Master batch records, change control requests, deviations, and development reports.
• Provide guidance to product development technicians in data collection and analysis.
• Evaluate and compile stability data.
• Prepare product specifications and assemble documentation to support regulatory dossiers.
• Work closely with manufacturing and operations teams to monitor production runs and transfer new products to industrial production.
• Ensure compliance with cGMP, GLP, GCP, FDA, and EMA guidelines.
• Identify and support initiation of Deviations, CAPAs, and Investigations.

Essential Skills

• Experience in formulation, process development, and project management in the pharmaceutical industry.
• Strong knowledge of QbD and DOE approaches.
• 3 years of experience in pharmaceutical formulation or process development.
• BS/MS degree in Chemistry or equivalent (MS preferred).

Additional Skills & Qualifications

• Experience in process scale-up, engineering, or technical transfer.
• 5 years of pharmaceutical or project management experience is ideal.
• Understanding of granulation, film coating, compression, and extrusion manufacturing concepts preferred.
• Knowledge or experience with GUMP software preferred.

Work Environment

The role is based in the R&D building, which houses a dynamic and evolving team of scientists and technicians. The work environment includes both GMP and non-GMP areas, with an open floor-plan office. The position requires 60-70% desk work and 30-40% hands-on execution. The standard shift is Monday to Friday, 8:00 AM to 5:00 PM, with some flexibility.

Pay and Benefits

The pay range for this position is $48.00 - $67.00/hr.

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in BRIDGETON,MO.

Application Deadline

This position is anticipated to close on Feb 13, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $48 - $67