Senior Scientist AR&D
hace 5 días
Piscataway
Job DescriptionJob Title: Senior Scientist, Analytical R&DJob Description The Senior Scientist, Analytical R&D plays a key role in supporting analytical development and testing within a fast-paced generic pharmaceutical environment. This role focuses on hands-on analytical testing of active pharmaceutical ingredients, excipients, in-process materials, and finished dosage forms, ensuring compliance with cGMP and global regulatory guidelines. The position emphasizes strong execution of established laboratory procedures, accurate documentation, and effective use of modern analytical instrumentation to support product development, release, and qualification activities. Responsibilities • Develop and validate analytical methods, primarily using LC and GC, for active pharmaceutical ingredients, excipients, and dosage forms to support routine analysis in the Analytical R&D laboratory., • Optimize new and existing analytical methods for qualification and release testing of pharmaceutical products., • Perform hands-on analytical testing of APIs, excipients, in-process materials, and finished products using HPLC/UPLC, GC, UV-Vis, IR spectroscopy, TLC, MS, and other standard analytical techniques., • Execute established laboratory procedures independently, including assays, related-compound testing, dissolution, residual solvent analysis, and physical testing such as density, viscosity, and particle size., • Accurately document analytical data, calculations, chromatograms, observations, instrument outputs, and test results in accordance with cGMP and applicable regulatory guidelines., • Conduct routine calibration, verification, and basic maintenance of laboratory equipment to ensure reliable performance and data integrity., • Provide timely responses to internal and external inquiries related to analytical methods, test results, and laboratory capabilities., • Provide training and guidance to laboratory analysts and group members to build technical capabilities and expand the analytical skill set of the team., • Ensure that analytical procedures are technically sound and conform to appropriate standards of identity, strength, quality, and purity of components., • Evaluate, recommend, and implement new analytical technologies and instrumentation to enhance testing efficiency and capability., • Stay current with new developments in analytical technologies and contribute to continuous improvement of laboratory operations and GMP compliance., • Lead team members on assigned projects when required, providing technical direction and ensuring project milestones are met., • Participate in and lead scientific discussions on projects with cross-functional teams, contributing analytical expertise to development strategies., • Assist with reverse engineering of reference products by developing, qualifying, and applying analytical methods to characterize dosage forms., • Support regulatory document compilation by contributing method descriptions, validation summaries, and analytical data as needed., • Execute method-development and validation experiments under the direction of responsible scientists, providing analytical support rather than independent design., • Perform testing of transdermal patches and other specialized dosage forms for drug content, purity, degradation products, adhesive properties, and visible defects, with training provided as needed., • Contribute to improvement initiatives that increase laboratory efficiency, robustness of methods, and adherence to cGMP.Essential Skills, • Bachelors degree (BA/BS) in Chemistry, Pharmacy, Pharmaceutical Sciences, or a closely related scientific discipline., • Masters degree (MS/MA) in Chemistry, Pharmaceutical Sciences, or related field preferred; Ph.D. in pharmaceutical sciences or related subject is an additional advantage., • Approximately 8 or more years of pharmaceutical experience with a bachelors degree, 6 or more years with a masters degree, or up to one year with a Ph.D., in roles involving analytical testing in a cGMP environment., • Strong, hands-on analytical laboratory experience in a pharmaceutical setting, with the ability to begin supporting testing with minimal guidance., • Extensive experience in cGMP laboratory testing and sound cGMP documentation practices., • Broad knowledge of modern analytical equipment and techniques, including HPLC/UPLC, GC, UV-Vis, IR spectroscopy, TLC, and MS., • Demonstrated experience in method development and validation for pharmaceutical products and raw materials., • Experience writing standard operating procedures (SOPs) and analytical test methods., • Experience with regulatory document compilation and familiarity with FDA, EMA, and ICH guidelines., • Ability to execute established analytical procedures independently and consistently in a regulated environment., • Intermediate-level written and verbal communication and presentation skills, with the ability to document and explain technical results clearly., • Intermediate-level organizational skills, including the ability to set priorities, manage multiple tasks, and follow through on commitments., • Intermediate proficiency with Microsoft Office and ability to learn additional software and laboratory data systems as needed., • Ability to lead projects, coordinate activities, and meet deadlines in a dynamic environment., • Creativity and problem-solving skills to address technical and compliance challenges in analytical testing., • Enthusiasm and dedication to perform as both an individual contributor and effective team member.Additional Skills & Qualifications, • Bachelors degree in Chemistry or related science discipline is required; masters degree in Chemistry or related science discipline is preferred., • Ph.D. in pharmaceutical sciences or a related subject is preferred for candidates with limited industry experience., • Chemistry, pharmacy, pharmaceutical sciences, or closely related scientific background strongly preferred., • U.S. pharmaceutical experience is preferred, although strong candidates with relevant international experience may be considered., • Experience with multiple dosage forms, including solid, semi-solid, liquid, suspensions, thermal, inhalation, and injectable products, is highly beneficial., • Experience in inhalation and transdermal product testing is advantageous but can be trained and is not required., • Experience with wet chemistry techniques and bench-level sample preparation and analysis., • Demonstrated ability to work in a generic pharmaceutical environment with high throughput and diverse product portfolio., • Comfort working on cross-functional teams and contributing to scientific discussions and project decision-making., • Ability to adapt to evolving priorities and maintain flexibility with work hours when project needs require extended or weekend work.Work Environment This role is based in a very fast-paced generic pharmaceutical environment within an Analytical R&D team of approximately 1520 people. The position follows a first-shift schedule, typically 8:00 a.m. to 4:30 p.m., with the expectation that the scientist remains flexible and can come in on weekends or stay late when project timelines require additional support. The laboratory is equipped with a broad range of modern analytical instrumentation, including HPLC/UPLC, GC, UV-Vis, IR spectroscopy, TLC, MS, and equipment for physical testing of dosage forms. The organization offers a robust training program that provides exposure to almost every dosage form, including solid, semi-solid, liquid, suspensions, thermal, inhalation, injectable, and transdermal products, enabling continuous learning and skill development. Work is performed in a cGMP-compliant environment with strict adherence to regulatory standards and comprehensive documentation practices. The culture emphasizes collaboration, scientific rigor, and continuous improvement, with opportunities to lead projects, contribute to cross-functional teams, and expand analytical capabilities. Dress code is typical for a laboratory-based pharmaceutical setting, requiring appropriate professional attire and use of standard personal protective equipment when working in the lab. Job Type & Location This is a Contract position based out of PISCATAWAY, NJ. Pay and Benefits 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) Workplace Type This is a fully onsite position in PISCATAWAY,NJ. Application Deadline This position is anticipated to close on Oct 16, 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. If you would like to request a reasonable accommodation, such as the modification oradjustment 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 thecity and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records. Massachusetts Lie Detector:It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall 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 applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.
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