Share Email Opening Title Scientist II – Analytical Development  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 highly experienced chemistry to join as Scientist II – Analytical Development. In this role you will support early-stage product development through commercialization. You will support and troubleshoot the formulation and manufacturing processes, identify potential negative interactions, degradation pathways, subsequent impurities, and degradants. As a Scientist III you will also perform qualification of analytical instrumentation, method development and validation, and method transfer activities. How You Will Make An Impact: Utilize knowledge of mechanistic organic chemistry to identify issues in drug product formulations. Predict impurity profiles and degradation pathways for active pharmaceutical ingredients and drug product by using the structures of active pharmaceutical ingredients and excipients. Participate in or lead the design/evaluation activities as well as execution of routine and more complex testing or studies. Provide analytical leadership on one or more client projects and represent the function on client project team(s). Present interpreted results and updates to internally and to individual clients in a timely and professional manner. Perform method development/validation and method transfer. Develops analytical methods for dissolution and chromatographic analysis. Authors/reviews validation and method transfer protocols. Acts as subject matter expert for analytical technology transfer. Review all relevant data (stability, specifications) in order to identify and report trends or OOS results Participate in or lead problem solving (scientific, equipment, process). Assist in trouble shooting and investigations as required. Perform testing and data peer review in accordance with written procedures for stability, clinical, formulation development, and method development/validation. Authors/reviews analytical protocols, SOPs, investigations, reports and related documentation. Assists laboratory management with acquisition, upgrade and qualification of instruments.   Position Requirements Ideal Candidate Will Bring: Bachelor’s degree in Analytical/Organic Chemistry or related scientific discipline is required. Master’s Degree in Analytical or Organic Chemistry or related scientific discipline is highly preferred. Minimum of Ten (10) years of work experience in pharmaceutical or related laboratory work is required. Hands on experience with pharmaceutical analytical method development is required. Method development and validation experience for small molecule compounds is required. Experience writing method validation protocols and reports, SOP's, technology transfer and other technical summary reports is required. Solid understanding of pharmaceutical chemical degradation, including identification and mitigation of degradation pathways. Demonstrates advanced technical knowledge of analytical methods spectroscopic technologies, chromatographic techniques and basic trouble shooting skills for typical High Performance Liquid Chromatography (HPLC) and Gas Chromatography (GC) Working knowledge of GLP/cGMP regulations and safety procedures. Maintains knowledge of pertinent literature, regulatory guidelines, laboratory techniques and instrumentation relevant to the discipline, area or section. Ability to support and coordinate projects in various stages of the development process. Good interpersonal skills and ability to work effectively in a team environment and client companies. Experience with electronic document management systems, LIMS, Empower and 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. Specific vision abilities required by this job include close vision, distance vision, color vision, and ability to adjust focus. Must have corrected visual acuity of 20/40 or better bilaterally. Must be able to pass color/contrast testing passing 9 of 12 elements. Ability to pass a Pulmonary Function Test (PFT) and regularly be required to wear appropriate Personal Protective Equipment (PPE) such as a respirator (Bullard, 3M) for extended periods of time. Good comprehension of written and verbal English, with excellent communication skills.   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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