Share Email Opening Title Scientist II, Analytical Development  Category Analytical Development   Description Why Join Societal CDMO? Mission and Culture: Each day we Bring Science to Society as we work towards improving the quality of life for patients who benefit from the therapies that we manufacture. We strongly believe that every employee plays an impactful role in accomplishing our mission of improving patients lives through client partnerships. Whether you are working hands-on in developing, manufacturing, or, testing the products or if you are utilizing your expertise in any other way, through your work here you will have an opportunity to positively affect countless lives. We foster a culture that is diverse, inclusive, challenging,and supportive. At Societal, we are committed to continuous improvement both as individuals and as an organization. We encourage our employees to continue their personal and professional development in various ways. Your New Role At Societal: We are looking for a Scientist II in the Analytical Development Department. In this role, your primary objective is to support early-stage product development through commercialization. You will perform such as analytical testing, method development and validation, method transfer, and equipment purchase and qualifications. How You Will Make An Impact: Perform testing and data peer review in accordance with written procedures for stability, clinical, formulation development, and method development/validation. Documents laboratory activities Process electronic data using procedures that ensure data integrity Perform and document daily standardization and performance verifications on laboratory equipment Perform controlled substance chain of custody documentation and reconciliation Evaluate and interpret the test and experimental data, and draws a conclusion based on results. Resolves technical issues and interprets and uses experimental data to expand on issues. Troubleshoots technical procedures, methodology and instrumentation Transcribes results into analysis reports Performs method development/validation and method transfer Develops analytical methods for dissolution and chromatographic analysis Acts as a subject matter expert for analytical technology transfer Authors/reviews analytical protocols, SOPs, reports and related documentation. Ensures laboratory reference standards are maintained in compliance with controlled substance and site SOPs and the site EH&S manual. Assists with periodic maintenance/calibration of laboratory equipment. Assists laboratory management with acquisition, upgrade, and qualification of instruments. Complies with site wide and departmental procedures including but not limited to change control, documentation, deviation reporting, cGMP compliance, safety and electronic data security.   Position Requirements   Ideal Candidate Will Bring: Bachelor’s Degree in chemistry or related scientific discipline is required. A minimum of five (5) years of work experience in pharmaceutical or related laboratory work is required. Hands-on experience with pharmaceutical analytical method development is highly preferred. Experience writing validation protocols and summary reports, analytical test protocols, SOP’s and other technical summary reports is highly preferred. Demonstrates advanced technical knowledge of analytical methods. Working knowledge of GLP/cGMP regulations and safety procedures Knowledge of Analytical Development operations and ability to support and coordinate projects in various stages of the development process. Extensive experience in the use of computers for analysis of data and generation of reports and in the use of software packages including Microsoft Office (Word, Excel, and Outlook) Experience with electronic document management systems. Such as Veeva and chromatography data management software (Empower/Chemstation) Demonstrate a general understanding of chromatographic techniques and basic troubleshooting skills for typical High Performance Liquid Chromatography (HPLC) and Gas Chromatography (GC) related problems. Benefits: At Societal, we offer a diverse and competitive total rewards package to attract and retain talent.  In addition to base compensation, all employees are eligible for one of our annual performance opportunities (bonus or commission) and equity-based long-term incentive. In addition, we offer a wide range of benefits including medical, dental, vision, paid time off, paid company shutdowns and holidays, 401k matching, life insurance, paid parental leave and much more. Who is Societal: Societal is a bi-coastal contract development and manufacturing organization (CDMO) with expertise to deliver on our client’s needs, regardless of complexity level. These projects span pre-Investigational New Drug (IND) development to commercial manufacturing and packaging for a wide range of therapeutic dosage forms. We provide industry-leading support for small molecule therapeutic development, end-to-end regulatory support, clinical and commercial manufacturing, aseptic fill/finish, lyophilization, packaging, and logistics services to the global pharmaceutical market. We do all of this in our best-in-class facilities in San Diego, California, and Gainesville, GA. If you would like to apply for this position, please visit our website at www.societalcdmo.com and click on the "Careers" section. New hires will pass a background check, drug screen, and will be required to show proof of COVID vaccination (subject to limited qualified exemptions) as a condition of employment. We are an equal opportunity employer (EOE) dedicated to a diverse workforce and Drug Free work environment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other characteristic protected by law.  If you require an accommodation to complete the application or interview process, please contact careers@societalcdmo.com.   About the Organization Societal is a bi-coastal contract development and manufacturing organization (CDMO) with expertise to deliver on our client's needs, regardless of complexity level. These projects span pre-Investigational New Drug (IND) development to commercial manufacturing and packaging for a wide range of therapeutic dosage forms. We provide industry leading support for small molecule therapeutic development, end-to-end regulatory support, clinical and commercial manufacturing, aseptic fill/finish, lyophilization, packaging and logistics services to the global pharmaceutical market. We do all of this in our best-in-class facilities in San Diego, California and Gainesville, Georgia. New hires will pass a background check and drug screen as a condition of employment.   EOE Statement We are an EOE dedicated to a diverse workforce and a Drug-Free work environment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other characteristic protected by law. If you require an accommodation to complete the application or interview process, please contact careers@societalcdmo.com.   EmpID None Specified  This position is currently not accepting applications. To search for an open position, please go to http://Societal.appone.com WE ALSO RECOMMEND Other Jobs Within Same Category -- None found -- Other Jobs Within 60 Miles -- None found --

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