Share Email Opening Title Scientist II, AD  Category Analytical Development   Description Why Join Recro: Mission and Culture: Our leadership proactively works to create and foster a culture that exemplifies our core values and mission. We strive to provide a work environment that is diverse, inclusive, challenging, and supportive. We are committed to continuous improvement both as individuals and as an organization and encourage our employees to continue their personal and professional development in a variety of ways. We strongly believe that every employee plays a crucial role in accomplishing our mission of improving patients’ lives through client partnerships. Whether you are working hands on developing, producing 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. Benefits: We offer a competitive total rewards package that includes health benefits, annual performance bonus, stock options, generous paid time off, holiday shutdowns, parental leave, matching 401k contributions and much more! Your New Role: We are looking for a Scientist II – Analytical Development. In this role you will support early-stage product development through commercialization. You will focus on method development and validation for solid oral dosage analytical testing, including writing and revising SOPs, analytical procedures and other documentation. In addition, you will perform method transfer routine analytical testing, and equipment purchase and qualifications. How You Will Make An Impact: Accountability for the execution of analytical deliverables, communicating project obstacles to leadership and internal stakeholders. Be the primary technical interface with clients during meetings and teleconferences. Perform testing and data peer review in accordance with written procedures for stability, clinical, formulation development, and method development/validation. Develops analytical methods for dissolution and chromatographic analysis. Resolves technical issues and interprets and uses experimental data to expand on assignments whenever possible. Evaluates and interprets test and experimental data, draws conclusions based on results, and documents and communicates work appropriately. Documents laboratory activities including notebook/worksheet, electronic notebook, and LIMS entries according to procedures that define laboratory documentation practices. Performs controlled substance chain of custody documentation and reconciliation. Troubleshoots technical procedures, methodology and instrumentation. Authors/reviews validation and method transfer protocols. Acts as subject matter expert for analytical technology transfer. Authors/reviews laboratory investigations. Conducts investigations, determines root cause and documents results, as needed, in compliance with SOPs. 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.   Position Requirements Ideal Candidate Will Bring: Bachelor’s Degree in chemistry or related scientific discipline is required. 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. Good technical writing and communications skills. Good interpersonal skills and ability to work effectively in a team environment and client companies. Demonstrates project management skills. Ability to react quickly to changes in project priorities and timelines. Experience with electronic document management systems (Veeva) and chromatography data management software (Empower/Chemstation). Ability to support multiple projects simultaneously and serve as a senior technical contributor and/or independent project team member. May act as a project team lead. Candidates should demonstrate a general understanding of chromatographic techniques and basic trouble shooting skills for typical High Performance Liquid Chromatography (HPLC) and Gas Chromatography (GC) related problems.   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 --

Click here for technical assistance.