Scientist II

Job Description

Job Description

Job Title: Scientist II – Senior Analytical Research Scientist

Job Description

This role is a Senior-level position within an Analytical R&D laboratory, focused on executing and supporting analytical testing and method development for pharmaceutical drug substances, raw materials, and finished dosage forms. The Scientist II will perform hands-on analytical testing, contribute to method development and validation activities, and ensure that all work complies with cGMP standards and regulatory guidelines. The position requires strong pharmaceutical analytical-testing experience, sound documentation practices, and the ability to work independently in a fast-paced generic pharmaceutical environment.

Responsibilities

• Perform routine and complex analytical testing on active pharmaceutical ingredients (APIs), excipients, in-process materials, and finished pharmaceutical products using techniques such as HPLC/UPLC, GC, UV-Vis, IR spectroscopy, TLC, MS, and wet chemistry methods.
• Execute established laboratory procedures independently, including assays, related compounds testing, dissolution, residual solvent analysis, and physical tests such as density, viscosity, and particle size.
• Develop and validate analytical methods, primarily LC and GC, for APIs, excipients, and dosage forms to support routine analysis in the Analytical R&D laboratory, as needed.
• Optimize new and existing analytical methods for qualification and release testing of products under the guidance of Senior scientists or project leads.
• Accurately document analytical data, calculations, chromatograms, observations, instrument outputs, and test results in accordance with cGMP and applicable regulatory requirements.
• Perform routine calibration, verification, and basic maintenance of analytical instruments and laboratory equipment to ensure reliable and compliant operation.
• Ensure that analytical procedures are technically sound and conform to appropriate standards of identity, strength, quality, and purity for all tested components and products.
• Provide timely responses to internal and external inquiries related to analytical data, methods, and testing status.
• Provide training, guidance, and day-to-day technical support to laboratory analysts and group members to build technical capabilities and expand analytical expertise within the team.
• Contribute to the expansion of analytical capabilities in the Analytical Group by sharing knowledge of modern analytical techniques and instrumentation.
• Evaluate, recommend, and help implement new analytical technologies and instrumentation to improve testing efficiency, data quality, and compliance.
• Write and revise standard operating procedures (SOPs), analytical test methods, and related laboratory documentation to ensure clarity, consistency, and regulatory compliance.
• Assist with regulatory document compilation by providing accurate analytical data, method descriptions, and validation summaries as required.
• Stay current with developments in analytical technologies, cGMP expectations, and relevant FDA, EMA, and ICH guidelines, and apply this knowledge to laboratory operations and method practices.
• Contribute to continuous improvement of laboratory operations, focusing on increased efficiency, robust data integrity, and enhanced GMP compliance.
• Lead or coordinate team members on assigned projects, ensuring that milestones are met and analytical deliverables are completed on schedule.
• Participate in and, when appropriate, lead scientific discussions on projects with cross-functional teams, providing analytical insights and technical recommendations.
• Support reverse engineering of reference products by performing analytical characterization of dosage forms and components.
• Execute experiments that support method development and validation under the direction of the responsible scientist, without needing to independently design full method-development programs.
• Perform analytical testing on a variety of dosage forms, including solid, semi-solid, liquid, suspension, thermal, inhalation, injectable, and transdermal products, with training provided where needed.
• Contribute to testing of transdermal patches for drug content, purity, degradation products, adhesive properties, and visible defects, following established procedures and using appropriate equipment.
• Set priorities effectively, manage multiple assignments, and follow through on commitments to meet project deadlines in a fast-paced environment.

Essential Skills

• Bachelor’s degree (BA/BS) in Chemistry or a closely related science discipline is required; a background in biology alone is not suitable for this role.
• Strong, hands-on analytical laboratory experience in a pharmaceutical environment, with the ability to begin supporting testing activities with minimal guidance.
• Extensive experience performing analytical testing on finished pharmaceutical products, including assays, related compounds, dissolution, residual solvents, and physical testing (density, viscosity, particle size).
• Broad knowledge of modern analytical equipment and techniques, including HPLC/UPLC, GC, UV-Vis, IR spectroscopy, TLC, and mass spectrometry.
• Demonstrated method development and validation experience, particularly with LC and GC methods for APIs, excipients, and dosage forms.
• Extensive experience working in a cGMP laboratory environment, with strong understanding of cGMP documentation practices and data integrity requirements.
• Strong knowledge of applicable FDA, EMA, and ICH guidelines relevant to pharmaceutical analytical testing and method validation.
• Ability to execute established laboratory procedures independently, maintaining high accuracy and attention to detail.
• Experience writing standard operating procedures (SOPs), analytical test methods, and related laboratory documentation.
• Experience contributing to regulatory document compilation by providing accurate analytical data and method information.
• Enthusiasm and dedication to performing as both an individual contributor and as a member of a collaborative team.
• Intermediate-level written and verbal communication and presentation skills, sufficient to explain analytical results and participate in scientific discussions.
• Intermediate-level organizational skills, with the ability to set priorities, manage time effectively, and follow through on commitments.
• Intermediate proficiency with Microsoft Office and the ability to learn additional software and laboratory programs as needed.
• Ability to lead projects and meet deadlines, including coordinating with team members and cross-functional stakeholders.
• Creativity in solving technical and compliance-related problems within a regulated laboratory setting.
• For Senior-level consideration: typically 8 or more years of pharmaceutical experience with a bachelor’s degree, 6 or more years with a master’s degree, or a strong educational background with a Ph.D. and relevant experience.
• Demonstrated experience testing APIs, excipients, in-process materials, and finished products using multiple analytical techniques and dosage forms.

Additional Skills & Qualifications

• Master’s degree (MS/MA) in Chemistry or other relevant pharmaceutical sciences is preferred and may reduce the required years of experience.
• Ph.D. in pharmaceutical sciences or a closely related subject is preferred for candidates with less industry experience.
• background in pharmacy, pharmaceutical sciences, or closely related scientific fields is highly beneficial for Senior Scientist roles.
• Approximately five or more years of relevant pharmaceutical analytical experience with a bachelor’s degree, or three to five years with a master’s degree, are preferred for Senior-level assignments.
• Method-development experience is helpful but not a primary requirement; the emphasis is on strong execution of analytical testing.
• Prior U.S. pharmaceutical experience is preferred, although candidates with strong international pharmaceutical experience will also be considered.
• Experience working with multiple dosage forms, such as solid, semi-solid, liquid, suspension, thermal, inhalation, injectable, and transdermal products, is an advantage.
• Exposure to inhalation and transdermal analytical testing is beneficial but not required, as these skills can be trained.
• Experience leading scientific discussions and collaborating with cross-functional teams on analytical and development projects.
• Demonstrated ability to stay abreast of new developments in analytical technologies and apply them to improve laboratory operations.
• Experience in a fast-paced generic pharmaceutical environment is a plus.
• Comfort working as part of an Analytical R&D team of 15–20 people and contributing to group goals.
• Willingness to support reverse engineering of reference products through analytical characterization.
• Flexibility to support weekend work or extended hours when project timelines or testing needs require it.

Work Environment

This position is based in a fast-paced generic pharmaceutical Analytical R&D laboratory environment, with two Senior Scientist II roles available for approximately nine-month assignments. The role operates primarily on a first-shift schedule, typically from 8:00 a.m. to 4:30 p.m., and requires flexibility to work occasional weekends or stay late when project demands arise. The Scientist II will work as part of an AR&D team of roughly 15–20 professionals, collaborating closely with colleagues on multiple concurrent projects. The laboratory is equipped with a wide range of modern analytical technologies, including HPLC/UPLC, GC, UV-Vis, IR spectroscopy, TLC, MS, and instruments for physical testing such as density, viscosity, and particle-size analysis. The environment emphasizes strong cGMP compliance, rigorous documentation, and adherence to FDA, EMA, and ICH guidelines. Team members benefit from a comprehensive training program that provides exposure to almost every major dosage form, including solid, semi-solid, liquid, suspension, thermal, inhalation, injectable, and transdermal products. Work is performed in a professional laboratory setting with appropriate safety protocols, personal protective equipment, and standard laboratory attire. Collaboration, continuous learning, and high-quality analytical results are central to the culture, offering an engaging environment for experienced scientists who enjoy hands-on analytical work and project leadership responsibilities.

This is a Contract position based out of PISCATAWAY, NJ.

The pay range for this position is $38.00 - $43.00/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)

This is a fully onsite position in PISCATAWAY,NJ.

This position is anticipated to close on Sep 28, 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 withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

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