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Sr Chemist - Analytical Development

Category Chemistry City Maple Grove State Minnesota

The Sr. Chemist, Analytical Development will represent Analytical Development or Pharmaceutical Sciences (Pharm Sci) as a project team member. Provide analytical and technical leadership to support new product development. Lead or serve as a technical consultant to a multidisciplinary team to resolve critical technical problems. Provide coaching and mentorship to junior chemists. Drive new technology evaluation and application

Assists with the development of project analytical strategy that will drive the development of generic drug product in Upsher-Smith's development pipeline. Under the direction of the Principle Chemist, leads the execution the analytical strategy. Provides coaching and mentorship to junior chemists. Stays current with evolving regulatory requirement and evaluate new technologies that improve effeciency and productively in the analytical laboratory.

  • Assist the Principle Chemist with developing analytical strategies that will drive the development of generic drug product in Upsher-Smith's development pipeline.
  • Responsible for analytical deliverables and to provide them to the project team on-time and on-budget. Deliverables include those coming from internal resources and contract laboratories.
  • Author company policies, departmental SOPs, test methods, validation protocols and reports, deviations, specifications, justifications, risk assessments and other related documents. Critically review these documents types when authored by team members.
  • Lead laboratory investigations (including development, OOS and OOT investigations) to identify the root cause and implement resolutions. Author SOP/method deviations and justifications as needed.
  • Author and gather CMC documents to support ANDA submissions.
  • Evaluate API and raw material suppliers through sample analysis and DMF/Techicnal Package review. Review solid state characterization (i.e. polymorphism) data and work with supplier or external contract laboratory to obtain required data if necessary.
  • Develop the testing and method validation strategy for new products that is consistent with ICH guidelines and FDA expectations. Execute strategy (including  method development, test method authoring and method validation) in coordination with team members.
  • Oversee the sourcing and procurement of reference standards. Ensure characterization of non compendial reference standards is consistent with ICH guidelines and meets current FDA expectations.
  • Maintain personal and shared work space in an organized manner. Follow Laboratory Norms and participate in lab-wide clean-up and inspection activities.
  • Serve as laboratory representative in company-wide initiatives. Follows through with implementation
  • Stay current with revisions to applicable USP general chapters and monographs. Proactively implement changes to Upsher-Smith systems to remain current with effective published compendia.
  • Provide formal training for instrumentation, procedures and/or software for new employees and cross-training of current employees. Provide technical guidance to junior chemists and displays competence, maturity and diplomacy when confronting behavior issues within the work group.
  • Responsible for proper handling of controlled substances. Comply with all DEA regulations and internal SOPs when using controlled substances.
  • Oversee testing at contract laboratories. Obtain quotations, request POs and track accruals of ongoing work. Ensure results are obtained in timely manner.

Requirements:

Bachelors Degree with 10+ years of experience in analytical chemistry. Advanced knowledge of analytical techniques, including HPLC, GC, and dissolution, with demonstrated troubleshooting skills. 
Experience with PC's, cGMP's, USP testing, FDA guidances, and ICH guidelines. Independent method development experience with a successful track record using key techniques is required.

Travel Requirements: Up to 25%

Other knowledge, skills and abilities:

Demonstrates cooperation and professionalism with all members of the Upsher-Smith organization. 
AProven problem solving and leadership skills.bility to understand the concepts involved in various test procedures in order to evaluate the reliability of obtained results.
Ability to write new procedures clearly and concisely which are easily understood, communicate clearly and effectively on technical concepts and rationales.
Ability to work independently, with others and to multitask. bility to multitask, prioritize, and work under pressure with competing tasks.
Initiative and drive to learn and master complex new concepts for projects.
Computer skills and experience with related software.
Deals with changes associated project needs, directions, and processes without being negatively impacted in productivity and efficiency


Upsher-Smith Laboratories, LLC. is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment, Upsher-Smith Laboratories, LLC. will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rights commission activity, status as a protected veteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category.
Job ID 8068

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