Scientist

Job Title: Scientist – Analytical Method Transfer (Sterile Injectables)

Job Description

This Scientist role focuses on leading analytical method transfer, verification, and co‑validation activities that support sterile injectable products within a pharmaceutical Quality Control environment. The position serves as a key technical expert for critical tests associated with new product launches and provides leadership on the conformance of release and stability profiles as documented in development reports and regulatory submissions. Working on site in the laboratory, the Scientist independently executes complex and non‑routine analytical methodologies, supports product validation and stability studies by identifying trends in data, and provides troubleshooting expertise for analytical methods and instrumentation across testing laboratories.

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 vendor and USP analytical methods for use in the laboratory.
• Review results and prepare verification reports following the execution of method transfers and verification protocols, ensuring data integrity and compliance with regulatory expectations.
• Act as liaison between Innovation & Development, Production Units, and the Quality Control Chemistry laboratory to facilitate the transfer and implementation of new analytical testing procedures.
• Serve as subject matter expert for the performance of critical analytical tests that support new product launches, ensuring methods are robust and suitable for routine use.
• Provide knowledge leadership within Quality Control on the conformance of release and stability profiles, aligning analytical results with development reports and regulatory submissions.
• Identify, investigate, and resolve complex analytical problems occurring in Quality Control laboratories, providing technical support and troubleshooting for methods and instrumentation.
• Prepare and contribute to documentation for regulatory submissions related to analytical methods, validation, and product quality data, as required.
• Review, update, and approve technical documentation such as protocols, test methods, standard operating procedures, and raw material and finished product specifications.
• Participate in the orientation and training of laboratory employees on new analytical method techniques, promoting best practices and adherence to procedures.
• Independently handle complex analytical projects with general guidance, establishing work priorities and ensuring assignments are completed on schedule.
• Function as an analytical project leader in inter‑departmental meetings, representing Quality Control and method transfer interests.
• Interface with Plant Operations and Technical Transfer personnel to resolve plant technical issues that require analytical chemistry expertise.
• Independently execute non‑routine and complex analytical methodologies within the Quality Control laboratory under the direction of scientific staff when needed.
• Evaluate, develop, and introduce new analytical techniques and technologies to the Quality Control laboratory to improve efficiency, robustness, and data quality.
• Act as a recognized subject matter expert in key analytical areas of interest, providing guidance to colleagues and stakeholders.
• Assist management and scientific staff in resolving complex analytical and manufacturing issues related to process chemistry.
• Analyze organic and inorganic compounds to determine their chemical and physical properties, composition, structure, relationships, and reactions using appropriate analytical techniques.
• Write, review, and update technical documentation such as protocols, reports, test methods, and SOPs to reflect current practices and regulatory requirements.

Essential Skills

• Extensive experience (minimum of 8 years) working under Good Manufacturing Practice (GMP) conditions within the pharmaceutical industry.
• Strong practical knowledge of analytical chemistry applied in an on‑site laboratory environment.
• Demonstrated expertise in method transfer, method verification, and co‑validation of compendial and non‑compendial analytical methods.
• Hands‑on experience with key analytical instrumentation, including High‑Performance Liquid Chromatography (HPLC).
• Hands‑on experience with Gas Chromatography (GC).
• Hands‑on experience with Fourier Transform Infrared Spectroscopy (FTIR).
• Hands‑on experience with UV‑Visible (UV‑Vis) spectroscopy.
• Hands‑on experience with Karl Fischer titration for moisture determination.
• Proficiency in spectroscopic methods relevant to pharmaceutical analysis.
• Proven ability to troubleshoot complex analytical methods and instrumentation issues.
• Strong technical writing skills for protocols, test methods, SOPs, reports, and regulatory documentation.
• Thorough understanding of pharmaceutical development processes and regulatory requirements related to analytical methods and product quality.
• Ability to identify trends in analytical data and interpret results in the context of product validation and stability studies.
• Capability to manage complex projects, set priorities, and meet timelines with limited supervision.

Additional Skills & Qualifications

• Experience working with sterile injectable products, such as prefilled syringes and IV bag presentations.
• Familiarity with analytical support for complex molecules and products such as heparin, chemotherapy drugs, and antibiotics in IV bags.
• Experience serving as a subject matter expert for critical analytical tests in support of new product launches.
• Experience preparing documentation for regulatory submissions related to analytical methods and product quality.
• Experience training and mentoring laboratory staff on new analytical methods and techniques.
• Experience acting as an analytical project leader in cross‑functional or inter‑departmental teams.
• Experience interfacing with plant operations and technical transfer functions to resolve manufacturing and process‑related analytical issues.
• Familiarity with coagulation testing techniques, including the use of coagulation analyzers and chromogenic assays.

Work Environment

This is a full‑time, on‑site laboratory position in a pharmaceutical manufacturing environment that operates on a normal first shift schedule, typically from 8:00 a.m. to 5:00 p.m. The role sits within an analytical services or method transfer function and works closely with, but separately from, the routine Quality Control testing team. The laboratory uses a range of analytical technologies, including HPLC, GC, FTIR, UV‑Vis, Karl Fischer titration, spectroscopic methods, and coagulation analyzers for chromogenic assays. The site is rapidly expanding its manufacturing capabilities, currently producing prefilled syringes and progressing toward more complex sterile injectable products in IV bags, including heparin, chemotherapy drugs, and antibiotics. The work environment emphasizes compliance with GMP, rigorous documentation, cross‑functional collaboration with operations and technical transfer teams, and continuous improvement of analytical efficiency and robustness

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.

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 6, 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.

analytical method transfer, method verification, high-performance liquid chromatography (hplc), co-validation, gas chromatography (gc), fourier transform infrared spectroscopy (ftir), uv-visible spectroscopy, karl fischer titration, spectroscopic methods, pharmaceutical development, regulatory documentation, technical writing, coagulation testing, project management, training and mentoring, stakeholder management, Senior Scientist, Senior Research Scientist, Senior Staff Scientist, Principal Research Scientist, Research Scientist, Principal Scientist, Associate Scientist, Research Associate - Biology II, Research Scientist & Data Analyst, Imaging Scientist