Job Title: Senior Raw Materials ConsultantJob Description
The Senior Raw Materials Consultant leads a strategic initiative to enhance and optimize the global Raw Materials Program for commercial GMP manufacturing operations. This role evaluates and improves raw material qualification processes, strengthens quality systems and documentation, and ensures alignment with regulatory expectations across the full product lifecycle. The consultant serves as a subject matter expert for raw materials and consumables, providing technical leadership, driving cross-functional collaboration, and delivering high-impact improvements with minimal oversight.
Responsibilities
- Lead and support the completion of a strategic initiative focused on improving and enhancing the global Raw Materials Program.
- Evaluate existing raw material qualification processes and identify opportunities for procedural and operational improvements.
- Ensure raw material quality systems align with commercial manufacturing and regulatory requirements across the product lifecycle.
- Revise and improve existing Raw Materials Standard Operating Procedures (SOPs) to strengthen quality and compliance.
- Author and implement new SOPs supporting raw material lifecycle management and qualification activities.
- Develop associated SOP Forms (SOPFORMs) and supporting documentation to standardize raw material processes.
- Author, revise, and review specifications, procedural documents, quality records, and other controlled quality system documentation.
- Ensure all documentation complies with GMP, quality system standards, and data integrity requirements.
- Serve as the subject matter expert for raw material and consumable qualification activities throughout the product lifecycle.
- Support and refine qualification strategies for raw materials utilized in commercial manufacturing operations.
- Assess existing qualification programs and provide recommendations to improve efficiency, compliance, and risk mitigation.
- Establish and refine appropriate controls for material qualification, lifecycle management, and ongoing monitoring.
- Provide expertise in material release and disposition processes supporting commercial manufacturing.
- Support investigations, assessments, and quality decisions associated with raw materials and consumables.
- Collaborate closely with Quality Control, Manufacturing, and Supply Chain teams to ensure compliant material management practices.
- Provide technical guidance on solid and liquid raw material sampling programs.
- Review and improve raw material testing strategies and programs to optimize quality and compliance.
- Identify opportunities to reduce testing while maintaining regulatory compliance, product quality, and patient safety.
- Support risk-based approaches to raw material testing and qualification, incorporating science- and risk-driven methodologies.
- Partner with Quality Control, Quality Assurance, Manufacturing, Supply Chain, Regulatory, and Technical Operations teams on raw material initiatives.
- Provide technical leadership and recommendations on raw material quality-related projects and continuous improvement efforts.
- Support project timelines and drive deliverables to completion with minimal oversight, ensuring milestones are met and outcomes are achieved.
Essential Skills
- Bachelor"s degree in Chemistry, Biology, Pharmaceutical Sciences, Biochemistry, Microbiology, Chemical Engineering, or a related scientific discipline.
- Minimum of 10 years of Quality Control Raw Materials experience within the pharmaceutical, biotechnology, biologics, or broader life sciences industry.
- Extensive experience supporting commercial GMP manufacturing operations and associated quality systems.
- Demonstrated expertise in raw material and consumables qualification programs across the product lifecycle.
- Strong understanding of commercialization and product lifecycle management as it relates to raw material controls and qualification.
- Significant experience with material release and disposition processes in a GMP environment.
- Proven experience authoring, editing, and reviewing GMP quality documents, including SOPs, protocols, and reports.
- Strong knowledge of raw material specifications, SOPs, SOP Forms, protocols, reports, and quality system documentation.
- Experience supporting both solid and liquid raw material sampling and testing programs.
- Deep familiarity with GMP principles, quality systems, and data integrity requirements.
- Strong technical writing skills with the ability to create clear, concise, and compliant documentation.
- Ability to operate as a subject matter expert and provide technical leadership with minimal oversight.
Additional Skills & Qualifications
- Experience working within commercialization-focused environments and supporting products across their lifecycle.
- Background in pharmaceutical, biotechnology, biologics, or dermatology-related products.
- Demonstrated ability to collaborate effectively with cross-functional teams, including Quality Control, Quality Assurance, Manufacturing, Supply Chain, Regulatory, and Technical Operations.
- Track record of driving process improvements and implementing risk-based approaches to testing and qualification.
- Comfort working in an emerging, growth-focused organization and adapting to evolving processes and priorities.
- Interest in opportunities that may evolve into a full-time role based on performance and organizational needs.
Work Environment
This role supports a small, growth-focused biopharmaceutical organization located in the Research Triangle Park (RTP) area. The company is dedicated to developing and commercializing innovative dermatology therapies for patients with unmet treatment needs and currently markets an FDA-approved treatment for molluscum contagiosum while expanding its portfolio through additional dermatology products. The work environment is dynamic and collaborative, with close interaction among Quality, Manufacturing, Supply Chain, Regulatory, and Technical Operations teams. The position offers flexibility and can be performed on site, remotely, or through a hybrid arrangement, enabling effective contribution to commercial GMP manufacturing and global raw materials initiatives while accommodating different working preferences.
Job Type & Location
This is a Contract to Hire position based out of Durham, NC.
Pay and Benefits
The pay range for this position is $75.00 - $100.00/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 Durham,NC.
Application Deadline
This position is anticipated to close on Aug 25, 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.