Description:

　　Performs analytical method validation, participates as a team member in complex technical investigation efforts, performs highly technical and specialized Analytical Scientist duties, performs laboratory analyses in the testing of raw materials for release, in process (IP), finished products (FP) during process validation and stability (ST) samples of test batches if needed. Performs and may oversee the validation of analytical methods for raw materials, IP, FP and ST samples using HPLC, UPLC, Gas Chromatography (GC), UV/Vis, automatic titrator, IR, AA and TLC and dissolution apparatus. Conduct and document chemical and physical tests of API, finished products, such as development of dissolution, assay and impurity methods, including pH stability and solubility study. Maintain approp doc of records, report sheets and lab notebooks as reqd by SOPs. Rev + eval compendial methods and proced. Write tech reports in response to FDA queries. Oversee calib of lab equip to ensure compliance with SOPs, cGLP and cGMP. Provide sci leadership to jr staff members. Collab with mgmt. to set priorities + reach objs. Prep valid protocol, valid reports, specs, investigation & non- conformance reports + other tech docs. Monitor timelines for investigations, stab testing + change control activs. Provide formal + informal training to research staff on tech subjs, admin proceds + reg reqs. Ensure compliance w/ company policies, proceds incl safety rules + regs

　　Additional Skills & Qualifications:

　　Must have Master’s degree in Chemistry, Pharm, or rel field and 2 yrs rel lab testing exp; or Bach degree in Chemistry, Pharm, or rel field and 5 yrs rel lab testing exp. Also req skill (2 yrs exp) in: cGLP or cGMP lab environment working with pertinent pharm SOPs for lab testing, analyses, and documentation; performing or overseeing validation for dissolution, assay, impurity, cleaning and residual solvent method of API and finished products, using HPLC, UV/IR, gas chromatography, TLC and dissolution apparatus as well as methods and techniques, including specificity, precision, accuracy, forced degradation, LOQ, LOD, stability and robustness; method development for API and finished products – including dissolution, assay and impurity methods and stability (pH and solubility), Empower 3;

　　Special Knowledge of skills needed, and or/licenses or certification required

　　· Good working knowledge of multiple analytical instruments which may include High-Pressure

　　Liquid Chromatography (HPLC), Gas Chromatography (GC), Ultra Violet Visible spectroscopy

　　(UV/Vis), automatic Titrator, Fourier-transform Infrared spectroscopy (FTIR), Gas

　　Chromatography- Mass Spectroscopy (GC-MS), Liquid Chromatography- Mass Spectroscopy (LCMS), Inductively coupled plasma mass spectrometry (ICP-MS) and dissolution apparatus

　　· Experience with Empower software

　　· Working knowledge of cGMP, Food and Drug Administration (FDA), Drug Enforcement

　　Administration (DEA) and Occupational Safety and Health Administration (OSHA) regulations

　　and guidance's

　　· Experience with Microsoft Office, including Excel

　　· Ability to work collaboratively, as required, in a fast paced, matrixed, team environment

　　consisting of internal and external team members

　　· Analytical thinking with problem-solving skills and the ability to adapt to changing priorities

　　and deadlines

　　· Planning, organization and time management skills including the ability to support and

　　prioritize multiple projects

　　· Fluent in English (verbal and written)

　　Diversity, Equity & Inclusion

　　At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are 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 connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.