Job Title: Formulation Scientist

Job Description

You will be assigned to external projects that include reviewing protocols, methods, reports, and conducting QbD Analysis. You will also be trained to assist and support current Formulation Development Scientists. This role involves the development and optimization of pharmaceutical products, identifying and evaluating new technologies or formulation processes. You will provide technical expertise in collaboration with other functional groups to prepare formulation development plans and meet project timelines. You will prepare laboratory, pilot, and industrial scale batches for various product dosage forms, ensuring compliance with cGMP, FDA, and EMA regulations and guidelines.

Responsibilities

• Lead and support the development of novel dosage forms and manufacturing processes for drug delivery.
• Prepare formulation development plans to establish and meet project timelines.
• Lead Quality by Design (QbD) and Design of Experiments (DOE) approaches to develop products and processes.
• Collaborate with the global product development team to prepare, execute, and evaluate stability of various product dosage forms.
• Troubleshoot problem processes and suggest improvements to manufacturing.
• Prepare and authorize manufacturing protocols, Master Batch Records, change control requests, deviations, and technology transfer 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.
• Adhere to cGMP, GLP, GCP, FDA, and EMA regulations and guidelines.
• Ensure data integrity and compliance with company SOPs and specifications.
• Identify and support initiation of Deviations, CAPAs, and Investigations.

Essential Skills

• Strong knowledge of GMP and EMA/FDA regulations.
• Experience with protocols and batch records.
• Ability to read and understand pharmacopoeial monographs.
• Minimum BS degree in Chemistry or equivalent; MS is ideal.
• 2 years of experience in pharmaceutical formulation or process development.
• Experience in process scale-up, engineering, or technical transfer.
• Understanding of granulation, film coating, compression, and extrusion manufacturing concepts.

Additional Skills & Qualifications

• Knowledge or experience with JMP software.
• Understanding of QbD principles or DOE.
• Knowledge of CMC requirements for pharmaceutical development.
• Knowledge of USP or EMA monographs for physical testing of in-process samples.

Work Environment

You will work in the R&D building with a team of 5 scientists and 4 technicians. The facility has several rooms with different equipment for research scale-up activities, some of which are GMP-compliant. The majority of your work will be in an open floor-plan office building with workstations for scientists. The shift is Monday to Friday, 8:00 AM to 5:00 PM, with some flexibility for planned runs. The team is dynamic and evolving, with new members, leadership, and projects. The culture is collaborative, with a focus on meeting deadlines for development projects.

Pay and Benefits

The pay range for this position is $48.00 - $52.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• 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 Mar 19, 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 - $52