Share Email Opening Title Supervisor, Analytical Development  Category Analytical Development   Description The Supervisor of Analytical Development oversees the daily operations of analysts responsible for a number of infrastructure items within the Analytical Development Group, including but not limited to: participating in method validation exercises, managing the AD Stability program, handling sample management and storage, overseeing the cleaning verification testing for PD/Manufacturing equipment, data review, scheduling testing within the AD group, coordinating training of personnel, and participation in appropriate internal improvement projects. The supervisor will answer questions that arise regarding cGMP and internal requirements of a particular activity or job function. The supervisor will communicate any non-compliant activities to management without delay. The supervisor is responsible for scheduling personnel and material resources to ensure that testing commitments and project timelines are satisfied and communicating any problems or difficulties to management. The supervisor is accountable for the accuracy, integrity, and security of all results generated by the working group. The supervisor will be required to review and/or approve SOPs, analytical procedures, analysis reports, validation documents, etc. at the discretion of management. The supervisor has the authority to approve and release data packages. The supervisor may recommend job actions regarding subordinate staff to management. Major Duties/Responsibilities Review data, protocols, and reports for method development, method validation, method transfers, and Pharm R&D support activities. Review and approve data packages that support on-going validation efforts for submission to the Validation department. Review and approve the results from contract labs. Review and countersign (when necessary) logbooks, notebooks, and worksheets for compliance with written procedures and assurance of data integrity. Identify deviations to written procedures. Write or review deviation investigation reports. Data Archival/Data retrieval. Serve as subject matter expert on operation and troubleshooting of select laboratory instrumentation (i.e. Empower software, Waters HPLC, Agilent Gas Chromatograph). Trending of test results to identify potential excursions from normal operating parameters. Assign testing based upon priorities and available resources and trained personnel. Supervise assigned projects to ensure compliance with all applicable procedures, and timely completion. Ensure compliance with the change control policy, and other site wide programs (i.e. documentation). Write, revise or review SOP’s, analytical protocols, analysis reports, specifications, and controlled forms. Ensure subordinate staff is adequately trained to perform job assignments. Execute training in accordance with written procedures, once certified as a qualified trainer. This would include but is not limited to training subordinate staff, perform training assessments, document training, and assist in the preparation of training programs and curricula. Ensure compliance with DEA regulations and internal controlled substances security and reconciliation programs. Identify OOS results, atypical results, and atypical laboratory events requiring a laboratory investigation. Initiate and supervise laboratory investigations. Train analysts in the investigation process. Write or review investigation reports and other forms required by the investigation procedure. Participates in personnel decisions (interviewing, hiring, performance appraisals, promotion, disciplinary action, staff development, coaching and counseling) regarding subordinate staff. Assemble and review time sheets for subordinate staff. Identify and report unsafe conditions within the laboratory. Lead or Supervisory Responsibilities Supervises work of others, including planning, assigning, scheduling and reviewing work, ensuring quality standards. Is responsible for hiring, terminating, training and developing, reviewing performance and administering corrective action for staff (may be subject to final approval by leadership). Plans organizational structure, position content and staffing. Indicate number of people within lead/supervisory scope in each category Leads 0 Directly Supervises 3-7 Indirectly Supervises 0   Position Requirements Education B.S/B.A. in chemistry or related scientific discipline (e.g., chemistry, chemical engineering, pharmacy) is required. Experience A minimum of eight (8) years working directly in a cGMP environment in either Quality Control lab or an Analytical Development Lab or a combination of the two for a pharmaceutical company focusing on solid oral dose products is required. Previous experience in supervising lab personnel is highly preferred. Hands on experience with pharmaceutical analytical development is highly preferred. Licenses, Certificates, Registrations cGMP candidate must be an SME on one or more of the following: Empower CMS; Agilent ChemStation Dissolution software; HPLC; Gas Chromatography; Dissolution; Laboratory Investigations, Cleaning Verification Knowledge/Skills/Abilities Demonstrates advanced technical knowledge of analytical methods. 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. Knowledge of analytical development, pharmaceutical development 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. The candidates must demonstrate a good understanding of basic chemistry and spectroscopic technologies (e.g. Ultraviolet (UV), Infrared (IR), Nuclear Magnetic Resonance (NMR), Mass Spectrometry (MS)) Candidates should demonstrate a good understanding of chromatographic techniques and basic trouble shooting skills for typical High Performance Liquid Chromatography (HPLC) and Gas Chromatography (GC) related problems. High level of pharmaceutical and technical knowledge and awareness of the drug development process. Good understanding of out of specifications Out of Specification (OOS) investigation process Good understanding of Good Manufacturing Practices requirements and awareness of relevant International Conference on Harmonization (ICH) and United States Food and Drug Administration (FDA) guidance documents Experience with electronic document management systems (Veeva) and chromatography and data management software (LIMS, 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.   LANGUAGE ABILITY: Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to construct investigation reports in a logical, scientifically defensible, clear, and persuasive manner. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public. MATH ABILITY: Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis. REASONING ABILITY: Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. COMPUTER SKILLS: A good working knowledge of MS Office (Word, Excel, PowerPoint, Access, Outlook). Ability to manipulate statistical software after training or Laboratory Information Management Systems (LIMs). Physical and Mental Demands and Work Environment The physical and mental demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. Physical Demands The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. While performing the duties of this Job, the employee is regularly required to sit and talk or hear. The employee is frequently required to use hands to finger, handle, or feel and reach with hands and arms. The employee is occasionally required to stand; walk; climb or balance; stoop, kneel, crouch, crawl or smell. 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. The employee 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. Mental Demands While performing the duties of this job, the employee is regularly required to use English written and oral communication skills; interact appropriately with staff, management contractors, vendors and others encountered in the course of work; read and interpret a variety of documents and instructions furnished in written, oral, diagram, or schedule form such as safety rules, operating and maintenance instructions, and procedure manuals; interpret technical and engineering data; generate technical reports of investigations; analyze and solve practical problems and deal with a variety of concrete variables; establish priorities and work on multiple assignments and projects concurrently. The employee is regularly required to apply computer skills covering word processing, spreadsheet and presentation software. The employee is regularly required to apply mathematical formulae and engineering rules of thumb to tasks and execute technical and engineering calculations. The employee must be able to manage multiple testing regimens. Work Environment In certain assignments, the employee will occasionally work with and around fumes or airborne particles, and toxic or caustic chemicals. The employee must wear appropriate personal protective equipment (PPE), such as a respirator, per site policies and SOPs. The noise level in the work environment is usually moderate to loud while working within the process areas. When the employee works within the office environment, the noise level is usually quiet to moderate.   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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