Job Description

Position Title: Manager, Analytical Development

Department:Product Development

Reports To:Director, Analytical Development

FLSA:Exempt

Grade:C1

Date:June 16, 2016

Purpose and Scope

Manages the development of appropriate assays for testing and release of pharmaceutical products, raw materials, and stability samples. Provide management oversight and leadership to the Analytical Development laboratory staff.

Essential Duties & Responsibilities

  • Oversee development of analytical methods to support multiple projects at different phases of maturity and facilitate successful method transfer.
  • Evaluate analytical data for validity.
  • Ensure that all operations and functions (including the laboratory) are in full FDA,GMP and/orGLP compliance and staff is properly trained.
  • Writes, reviews and/or approves technical reports, analyses, test methods against current guidelines and/or specifications.
  • Participate in audits (as needed) and directly interacts with potential marketing partners and regulatory agencies.
  • Provide a leadership role for Analytical Development.
  • Initiate and conduct laboratory investigations.
  • Manage and create regulatory documents for FDA submissions.
  • Prioritize projects to meet timelines and prepare/oversee work schedules to ensure on-time delivery of results within the analytical development group.
  • Generate and/or review certificate of analysis/testing and review stability reports when needed.
  • Manage testing of pharmaceutical products, raw materials, stability samples.
  • Develop and establish product specifications and participate in the coordination and writing of regulatory filings.
  • Hire, train, supervise, counsel and evaluate direct-report employees; conduct and submit annual performance appraisals; recommend/authorize pay adjustments as appropriate.
  • Set procedure and ensure compliance from Analytical Development staff.
  • Ensure compliance with all regulatory functions through independent management of projects and Analytical Development personnel.
  • Participate in project team meetings to aid in product development using technical expertise to facilitate analytical development of viable products to meet project goals.
  • Manage departmental spending to stay within the established budget.
  • Participates in required annual hazardous waste training. Hazardous waste involvement may include but is not limited to container and tank management and inspections, generation of hazardous waste as a part of production or sampling processes, and transfer of hazardous waste between lab procedure area, satellite accumulation, and storage. Responsible for daily activities and supervising staff that are hazardous waste generators and/or handlers. Respond to spills per CP 030-0202 Chemical Spill Response.
  • Perform other related duties as assigned.

Knowledge, Skills & Abilities

  • Expert knowledge of current Good Manufacturing Practices (cGMP), FDA and International regulations as they apply to laboratory work.
  • Ability to lead a team of analytical professionals that is fully compliant with current Good Laboratory Practices and Good Manufacturing Practices.
  • Excellent interpersonal, communication, problem-solving and organizational skills.
  • Excellent skill in effective oral and written communication.
  • Ability to prepare, review, conduct, develop and/or validate analytical methods and product specifications.
  • Strong ability to operate and troubleshoot analytical instrumentation.
  • Analytical troubleshooting and product investigation knowledge.
  • Ability to understand and troubleshoot product issues.
  • Ability to coordinate activities to assure customer needs and project goals are met.
  • Strong knowledge in analytical method development and validation and instrument qualification.
  • Demonstrated solid technical leadership when working on complex problems within a technical scope in which analysis of situations or data requires an in-depth evaluation of various factors.
  • Supervisory experience with exceptional interpersonal and organizational skills that lead directly to the advancement of others and of the department as a whole.
  • Knowledge of computer systems for sample tracking, laboratory equipment, raw data handling and storage.
  • Working knowledge of general accounting procedures.

Education& Experience

  • Bachelors degree in chemistry or a related discipline.
  • Eight or more years of related industry experience with a minimum of two years supervisory experience.

Working Conditions

  • Laboratory setting. Will be exposed to solvents, bio-hazardous materials, hazardous waste, and pharmaceuticals.

Employee SignatureDate

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