Sr. Formulation Scientist

Job Title: Formulation Scientist

Job Description

This role leads the end-to-end development, optimization, scale-up, and technology transfer of animal health pharmaceutical products across multiple dosage forms, including tablets, liquids, powders, chews, and other oral solid and semi-solid products. You will design and execute formulation and process development studies using Quality by Design (QbD) and Design of Experiments (DOE) principles, generate high-quality technical documentation, and collaborate closely with cross-functional teams to move products from feasibility through commercialization in a regulated GMP environment. The position combines significant project management and technical writing responsibilities with hands-on work in scale-up and manufacturing suites.

Responsibilities

• Lead the development, optimization, and scale-up of pharmaceutical formulations for animal health, including tablets, chews, liquids, powders, and other dosage forms from feasibility batches through commercialization.
• Design and execute formulation and process development studies using QbD and DOE principles, including identification and management of CMAs, CQAs, CPPs, and FMEA-based risk assessments.
• Establish robust manufacturing processes that meet quality, regulatory, and operational requirements for oral solid dose and other dosage forms.
• Prepare, review, and maintain technical documentation such as development reports, manufacturing protocols, master batch records, change controls, deviations, and technology transfer packages.
• Lead and support technology transfer activities from R&D to production, including process validation efforts and preparation of Pharmaceutical Development Reports (PDR) to support CMC documentation and dossier submissions.
• Collaborate cross-functionally with Analytical, Regulatory, Quality, Manufacturing, MSAT, Industrial Operations, and Operations teams to support product development, validation, scale-up, and commercialization.
• Evaluate and interpret stability data to support product development decisions and regulatory submissions, and contribute to responses to regulatory inquiries.
• Ensure compliance with cGMP, GLP, FDA, EMA, and internal quality system requirements throughout formulation and process development activities.
• Provide technical leadership and mentorship to junior scientists and development technicians, fostering scientific excellence, knowledge sharing, and continuous improvement.
• Support laboratory and operational compliance activities, including data integrity initiatives, investigations, deviations, CAPAs, safety programs, and adherence to SOPs.
• Coordinate with production and industrial operations to align formulation and process designs with manufacturing capabilities and constraints.
• Manage projects effectively, balancing multiple development initiatives, timelines, and deliverables in a fast-paced, deadline-driven R&D environment.
• Conduct literature searches and technical reviews to inform formulation strategies, process improvements, and problem solving.
• Participate in large audience meetings and cross-functional forums, presenting technical data, project status, and risk assessments clearly and confidently.
• Contribute to building a collaborative, close-knit team culture among scientists and technicians in a dynamic and evolving R&D group.

Essential Skills

• At least 5 years of pharmaceutical formulation and/or process development experience in a regulated GMP environment.
• Hands-on experience developing solid dosage forms, such as tablets and/or chews, in an R&D/GMP setting from feasibility batches through commercialization.
• Demonstrated expertise in formulation development, process scale-up, technology transfer, and pharmaceutical manufacturing of oral solid dose products.
• Strong mastery of QbD and DOE principles, including practical application of CMAs, CQAs, CPPs, and FMEA in process and formulation design.
• Experience with stability programs, including evaluation of stability data to support product development and regulatory submissions.
• Proven ability to prepare and review technical documentation, including development reports, manufacturing protocols, master batch records, change controls, deviations, and technology transfer packages.
• Experience supporting CMC documentation and dossier submissions, including writing Pharmaceutical Development Reports (PDR).
• Strong understanding of cGMP, FDA, EMA, and quality system requirements relevant to pharmaceutical development and manufacturing.
• Excellent written and verbal communication skills for effective collaboration across scientific, quality, regulatory, manufacturing, and operations teams, including international and large audience meetings.
• Demonstrated project management skills, with the ability to manage multiple development projects, timelines, and deliverables in a fast-paced environment.
• Ability to mentor and provide technical guidance to junior scientists and technicians, promoting scientific rigor and continuous improvement.
• Direct industry experience in pharmaceutical development and manufacturing, as opposed to purely academic experience.

Additional Skills & Qualifications

• Bachelor's degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related scientific field.
• Master’s degree in a relevant scientific or engineering discipline is preferred.
• Experience with process validation (PV) activities and technology transfer to production environments.
• Familiarity with pharmaceutical chemistry concepts and monographs, with the ability to understand analytical requirements and stability testing strategies (without performing analytical testing).
• Experience working within GLP and GMP laboratories and manufacturing suites.
• Strong adaptability and flexibility to thrive in a dynamic, evolving R&D environment with changing priorities and deadlines.
• Proven team-player attitude and ability to contribute to a close-knit, supportive, and collaborative team culture.
• Comfort working in cross-functional, international, and matrixed environments.
• Ability to perform both desk-based technical work and hands-on activities in scale-up or manufacturing suites.

Work Environment

The role is based in a dedicated R&D building that houses a team of approximately five scientists and four technicians working on animal health pharmaceutical development. The facility includes several rooms equipped with diverse research and scale-up equipment, with a mix of GMP and non-GMP areas to support different stages of development.

This is a Permanent position based out of BRIDGETON, MO.

The pay range for this position is $120000.00 - $150000.00/yr.

Bonus, PTO, Pet Insurance, 401K Match, Medical, Dental, Vision, 13 holidays.

This is a fully onsite position in BRIDGETON,MO.

This position is anticipated to close on Aug 27, 2026.

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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

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.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.

Salary : $120,000 - $150,000