Job Title: Senior Scientist Analytical Method Transfer and Quality ControlJob Description
This Senior Scientist role supports a pharmaceutical organization specializing in sterile injectable products by leading analytical method transfer, verification, and covalidation activities for both compendial and noncompendial methods. The position serves as a key technical expert within the Quality Control organization for critical tests associated with new product launches, release, and stability profiles, and provides advanced troubleshooting and analytical support across testing laboratories. The role is primarily laboratory-based and offers the opportunity to influence new product introductions, support regulatory submissions, and drive continuous improvement in analytical capabilities within a rapidly growing manufacturing site.
Responsibilities
- Coordinate and execute method transfers, method verifications, and covalidations of analytical testing procedures utilized within the Quality Control laboratory.
- Plan, execute, and document verification protocols to confirm vendor and USP analytical methods are suitable for their intended use.
- Review and interpret data and verification reports generated from method transfers and verification protocols, ensuring accuracy, completeness, and compliance with internal and regulatory expectations.
- Act as a liaison between Innovation & Development departments, Production Units, and the QC Chemistry laboratory to transfer and implement new analytical testing procedures.
- Serve as the subject matter expert for critical analytical tests that support new product launches, ensuring methods are robust and aligned with regulatory and development documentation.
- Lead knowledge within QC on the conformance of release and stability profiles as documented in development reports and regulatory submissions, and communicate findings to stakeholders.
- Identify, investigate, and resolve complex analytical and instrumentation issues occurring in QC laboratories, providing technical support and troubleshooting guidance.
- Prepare and contribute to documentation for regulatory submissions, including method descriptions, validation summaries, and analytical justifications, as required.
- Review, update, and approve technical documentation such as protocols, test methods, 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 instrumentation to ensure consistent and compliant execution.
- Independently execute nonroutine and complex analytical methodologies within the Quality Control laboratory under the direction of Senior scientific staff.
- Evaluate, develop, and introduce new analytical techniques and technologies to the QC laboratory to improve efficiency, robustness, and capability.
- Assist management and Senior scientific staff in resolving complex analytical and manufacturing issues related to process chemistry and product quality.
- Establish work priorities for assigned projects, manage timelines, and ensure analytical assignments and method transfer activities are completed on schedule.
- Function as an analytical project leader in interdepartmental meetings, representing QC and method transfer interests and providing expert input on analytical strategies.
- Interface with Plant Operations and Technical Transfer personnel to resolve plant technical issues that require analytical chemistry expertise.
- Execute routine and complex analyses of organic and inorganic compounds to determine chemical and physical properties, composition, structure, relationships, and reactions.
- Write and update technical documentation, including protocols, reports, test methods, and SOPs, with a strong focus on clarity, completeness, and regulatory alignment.
Essential Skills
- Extensive experience working under Good Manufacturing Practice (GMP) conditions, with a minimum of 8 years of experience in the pharmaceutical industry.
- Strong practical knowledge of analytical chemistry applied in a Quality Control or development laboratory environment.
- Hands-on experience with method transfer, method verification, and covalidation of compendial and noncompendial analytical methods.
- Demonstrated proficiency with key analytical techniques and instrumentation, including HPLC, GC, FTIR, UVVis, Karl Fischer, and other spectroscopic methods.
- Experience performing and interpreting stability and release testing for pharmaceutical products.
- Proven ability to write and execute protocols and reports for method transfers and method validations, including detailed technical documentation.
- Strong technical writing skills for drafting and revising protocols, test methods, SOPs, and validation reports.
- Ability to analyze complex data sets, identify trends, and draw scientifically sound conclusions in support of product validation and stability studies.
- Demonstrated capability to troubleshoot complex analytical methods and instrumentation issues in a laboratory setting.
- Solid understanding of pharmaceutical development processes and regulatory requirements related to analytical methods, release testing, and stability programs.
Additional Skills & Qualifications
- Experience acting as a subject matter expert for critical analytical tests supporting new product launches.
- Background in preparing or contributing to documentation for regulatory submissions related to analytical methods and product quality.
- Experience training and mentoring laboratory staff in new analytical techniques and methods.
- Experience leading analytical projects or serving as an analytical representative in crossfunctional or interdepartmental meetings.
- Familiarity with coagulation analyzers and chromogenic assays.
- Ability to evaluate, develop, and implement new analytical techniques to enhance laboratory efficiency and capabilities.
- Strong organizational skills with the ability to set priorities, manage multiple projects, and meet deadlines in a regulated environment.
- Effective communication skills for collaborating with Quality Control, Innovation & Development, Production, Technical Transfer, and Operations teams.
Work Environment
This is an onsite, firstshift laboratory position, typically working a normal 8:00 a.m. to 5:00 p.m. schedule. The role is approximately 80% laboratory-based, working at the bench to perform analyses, conduct method transfers, and troubleshoot analytical methods and instrumentation, with about 20% of the time dedicated to protocol writing and technical documentation. The position operates within a Quality Control and method transfer environment that supports a sterile injectable manufacturing site, including prefilled syringes and an expanding portfolio of more complex molecules in IV bags, as well as products such as heparin, chemotherapy drugs, and antibiotics in bags. The Senior Scientist collaborates closely with Analytical Services, Technical Transfer, and Plant Operations teams in a regulated GMP setting that emphasizes data integrity, safety, and continuous improvement. Laboratory work involves the routine use of advanced analytical instrumentation, including HPLC, GC, FTIR, UVVis, Karl Fischer, and coagulation analyzers, and requires adherence to established SOPs, protocols, and quality standards.
Job Type & Location
This is a Contract position based out of Wilson, NC.
Pay and Benefits
The pay range for this position is $50.00 - $55.00/hr.
Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.
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)
Job Type & Location
This is a Contract position based out of Wilson, NC.
Application Deadline
This position is anticipated to close on Nov 9, 2026.
Workplace Type
This is a fully onsite position in Wilson,NC.
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.
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