Share Email Opening Title Manager, 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 Manager, Analytical Development (AD) to join the AD team. In this role you will oversee a team responsible for analytical methods development, validation, transfer, testing and reporting. You will be a technical subject matter expert, assuring compliance with regulatory (cGMP, DEA, etc.) and company guidelines while keeping project plans, timelines and budgets on track. How You Will Make An Impact: Leading scientific development of new analytical methods and identifying opportunities for improvement on existing methods. Supporting validation for Process Development (PD) projects inclusive of oral controlled release dosage forms, active drug substance, raw materials, preformulation support, in-process components, and supporting stability (in-house and through outside contractors). Assessing budget and proposals and managing the purchase of laboratory equipment and supplies. Developing training requirements, and conducting training of staff. Write, revise or review SOP's, analytical protocols, analysis reports, specifications, and controlled forms. Review and approve relevant laboratory documentation. Lead qualification efforts for new and existing analytical equipment. Maintain and expand knowledge of analytical methods development capabilities, evolving technologies, and Regulatory environment. Assisting with preparation of development proposals, plans, project timelines, and the overall review of project activities. Overseeing the progress and direction of laboratory investigations. Participating in project management activities and as requested, may represent AD on project teams. Leading client communication and scientific related project discussions as the technical manager. Developing and achieving personal goals that align with overall business and project goals while assuring the same of any subordinate staff. Leading development of project plans and provides leadership in support of analytical transfer activities. Ensuring compliance with the change control policy, and other site wide programs (i.e. documentation). As A Leader You Will: Hire, train, develop, mentor and manage an AD team. Oversee, participate in and approve the interviewing, hiring and training of department employees. Conduct performance evaluations for direct reports; and assists direct reports with performance evaluation process for their units.   Position Requirements Ideal Candidate Will Bring: B.S./B.A. in chemistry or related scientific discipline (e.g., chemistry, chemical engineering, pharmacy) is required. Advanced degree (M.S. or PhD) is highly preferred. Minimum of 10 years of relevant work experience in a pharmaceutical analytical laboratory and a minimum of 5 years of experience developing/validating test methods for pharmaceutical products across the various phases of development is required Minimum of 3 years of prior leadership experience is required. Demonstrated advanced technical knowledge of analytical methods, including strong knowledge of common pharmaceutical raw materials, their applications, and the principles of formulation development. Working knowledge of phase appropriate GLP/cGMP regulations, investigation processes related to lab activities and trends along with understanding of safety procedures. High level of pharmaceutical and technical knowledge and awareness of the drug development process with the ability to support and coordinate projects in various stages of the development process. Proven ability to work effectively with client and internal project team members, dealing with differing technical opinions from those clients/team members in a professional, constructive, and effective manner. Thorough understanding of basic chemistry, organic chemistry, chromatographic techniques and spectroscopic techniques. Experience with electronic document management systems (Veeva), chromatography and data management software (LIMS, Empower/Chemstation) and experience with Sigmaplot, JMP or equivalent. Ability to write,  read, analyze, and interpret common scientific and technical documents. Ability to apply mathematical operations to such tasks as determination of test reliability and validity and statistical analysis. Specific vision abilities required by this job include close vision, distance vision and the ability to adjust focus. You may be required to pass a Pulmonary Function Test (PFT) and regularly be required to wear appropriate Personal Protective Equipment (PPE) such as a respirator (Bullard, 3M) in order to perform specific job duties.   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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