Scientist

Job Title: Senior Scientist – Analytical Method Transfer (Sterile Injectables) Job Description This on-site Senior Scientist role in a pharmaceutical environment focuses on leading analytical method transfer, verification, and co‑validation activities that support sterile injectable products. The position provides scientific leadership within the Quality Control organization, ensuring that analytical methods for release and stability testing are robust, compliant, and aligned with development reports and regulatory submissions. The Senior Scientist acts as a subject matter expert for critical tests associated with new product launches, supports troubleshooting of complex analytical issues, and helps drive the introduction of new analytical techniques to improve laboratory efficiency and support a rapidly growing manufacturing site. Responsibilities • Coordinate and execute method transfers, method verifications, and co‑validations of compendial and non‑compendial analytical testing procedures utilized within the Quality Control laboratory. • Plan, execute, and document verification protocols to confirm the suitability of vendor and USP analytical methods for their intended use. • Review and interpret analytical data and verification reports generated from method transfers and verification protocols, ensuring accuracy, completeness, and compliance with internal and regulatory standards. • Serve as the primary liaison between Innovation & Development departments, Production Units, and the Quality Control Chemistry laboratory to support the transfer and implementation of new analytical testing procedures. • Act as subject matter expert for the performance of critical analytical tests that support new product launches and ongoing commercial production. • Lead knowledge within Quality Control on the conformance of product release and stability profiles to development reports and regulatory submissions, identifying and communicating trends in data generated during validation and stability studies. • Identify, investigate, and resolve complex analytical and instrumentation problems occurring in Quality Control laboratories, providing technical support and troubleshooting guidance. • Prepare and contribute to documentation for regulatory submissions related to analytical methods, validation, and product quality as required. • Write, review, update, and approve technical documentation such as protocols, analytical test methods, reports, standard operating procedures (SOPs), and raw material and finished product specifications. • Participate in the orientation and training of laboratory employees on new analytical techniques, methods, and best practices, ensuring proper understanding and execution. • Independently execute non‑routine and complex analytical methodologies within the Quality Control laboratory under the general guidance of Senior scientific staff. • Evaluate, develop, and introduce new analytical techniques and technologies into the Quality Control laboratory to improve efficiency, robustness, and data quality. • Assist management and Senior scientific staff in resolving complex analytical and manufacturing issues related to the chemistry of processes and products. • Establish work priorities for assigned projects and ensure that analytical activities and deliverables are completed on schedule. • Function as an analytical project leader in inter‑departmental meetings, effectively representing the Quality Control analytical perspective and driving method transfer and validation activities. • Interface with Plant Operations and Technical Transfer personnel to address and resolve plant technical issues that require analytical chemistry expertise. • Analyze organic and inorganic compounds to determine their chemical and physical properties, composition, structure, relationships, and reactions using appropriate analytical techniques. Essential Skills • Extensive experience working under Good Manufacturing Practice (GMP) conditions, with a minimum of 8 years of experience within the pharmaceutical industry. • Strong, practical knowledge of analytical chemistry, including hands‑on experience with complex and non‑routine analytical methodologies. • Demonstrated expertise in method transfer, method verification, and co‑validation of compendial and non‑compendial analytical methods. • Proficiency with key analytical instrumentation and techniques such as High‑Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Fourier Transform Infrared Spectroscopy (FTIR), UV‑Visible (UV‑Vis) spectroscopy, Karl Fischer titration, and other spectroscopic methods. • Proven ability to troubleshoot analytical methods and instrumentation issues in a Quality Control laboratory setting. • Experience with method verification activities, including execution and evaluation of verification protocols for vendor and pharmacopeial methods. • Strong technical writing skills for authoring and reviewing protocols, analytical methods, reports, SOPs, and specifications. • Broad understanding of pharmaceutical development processes and regulatory requirements related to analytical methods, validation, release testing, and stability studies. • Ability to independently execute complex analytical work and manage multiple projects while maintaining high quality and compliance standards. Additional Skills & Qualifications • Experience serving as a subject matter expert in key analytical areas, particularly in support of sterile injectable or parenteral products. • Familiarity with preparing or contributing to analytical sections of regulatory submissions for pharmaceutical products. • Experience training and mentoring laboratory staff in new analytical methods and techniques. • Demonstrated ability to lead analytical workstreams or projects in cross‑functional and inter‑departmental settings. • Experience with coagulation testing, including use of coagulation analyzers and chromogenic assays. • Strong data analysis skills, including the ability to identify trends in validation and stability data and communicate their impact on product quality. • Ability to evaluate and introduce new analytical technologies or process improvements to enhance laboratory efficiency. • Comfort working closely with Operations and Technical Transfer teams to support scale‑up, technology transfer, and resolution of manufacturing issues. • Motivation to grow as a scientist, with interest in expanding expertise in protocol writing, validation, and broader development activities. Work Environment This is a full‑time, on‑site laboratory position in a pharmaceutical manufacturing environment focused on sterile injectable products. The role follows a normal first‑shift schedule, typically 8:00 a.m. to 5:00 p.m. Work is performed in a Quality Control and analytical services setting that uses advanced laboratory instrumentation such as HPLC, GC, FTIR, UV‑Vis, Karl Fischer titrators, coagulation analyzers, and related spectroscopic equipment. The site is rapidly expanding its manufacturing capabilities, currently producing prefilled syringes and moving toward more complex molecules in IV bags, including products such as heparin, chemotherapy drugs, and antibiotics in bags. The position sits within an analytical services or method transfer group that partners closely with, but is not part of, the routine QC testing team. The culture emphasizes scientific rigor, cross‑functional collaboration, and career development, with opportunities to build expertise in protocol writing, method validation, and advanced troubleshooting while supporting the introduction of new products and technologies. Job Type & Location This is a Contract position based out of Wilson, NC. Pay And Benefits The pay range for this position is $40.00 - $50.00/hr. Requirements 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 Wilson,NC. Application Deadline This position is anticipated to close on May 14, 2026. Diversity, Equity & Inclusion At Actalent, Diversity And Inclusion Are a Bridge Towards The Equity And Success Of Our People. DE&I Is 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 Actalent is an equal opportunity employer. About Actalent Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day. Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.