Job Description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

This position will oversee a team responsible for one of three functions: Day shift, Chromatography group, or Wet chemistry group.  These groups support raw material release, API (drug substance) release, in-process reaction completion testing and intermediate release, and stability testingin order tosupport the site’s fast-paced manufacturing needs.  A key opportunity in this role will be the development of staff to grow into future roles within the site.

Essential Functions:

• Provide day to day leadership to a team of approximately 3-8 analysts by performing the following: leading organizational change; developing and empowering staff; cultivating relationships; putting staff in a position to succeed, meeting their personal career goals while also achieving organizational goals; building effective teams that apply their diverse skills and perspectives to achieve common goals; driving engagement and creating a climate where staff are motivated to do their best.

• Revise/review specifications, SOPs, and other documentsregardingQC and assay execution.

• Train and supervise staffin order toperform QC tasks by ensuring completion of technique-related training, SOPs, OJT, and knowledge assessments, as well as ensuring on-going compliancetotraining and site SOPs.

• Participate in the discrepancy management process.

• Drive closure of deviations/ investigations/ CAPA.

• Interact with auditors/clients during visits and tours.

• Oversee daily activity for the group to ensure qualityresults

• Performance management for direct reports.

• Prepare and Assist in the Writing of Procedures (Standard Operating Procedures, Equipment Operating Procedures, Department Procedures,and LaboratoryInvestigations) accordance with established standard lead times.

• Effectively communicate with peers, manufacturing, AD and QC staff, to resolve technical issues and direct activities.

• Provide support to site Safety initiatives.

• Other job duties as assigned.

Education:

Bachelor’s degree in physical science, preferably in Chemistry.Other science degrees, with experience in a pharmaceutical analytical laboratory, will be considered.

Experience:

Requires a minimum of 5 years’ experience inquality/analytical/pharmaceuticalindustry or similar experience with a minimum of one year supervisory/ team lead experience within the pharmaceutical industry in a QA/QC leadership role, preferably with a plant manufacturing focus preferredKnowledge of QC analytical techniques isrequired(for example, HPLC, GC, KF, IR, optical rotation, etc.), Empower 3 experience for IPC and Chromatography group rolesispreferred.

Competencies:

Excellent knowledge and understanding of chemistry and analytical instrumental technologies. Excellent knowledge of qualitative and quantitative chemical analysis. Excellent understanding of quality and regulatory requirements in the pharmaceutical industry, including pharmaceutical GMPs and descriptive organic chemistry. Excellentproblem solvingskills andlogicalapproach to solving scientific problems. Excellentproficiencywith HPLC, GC, LC/MSKF, FTIR, and other wet chemistrymethodology Excellent interpersonal and communication skills (both oral and written). Good presentation skills to present information to customers, clients, and other employees. Good leadership skills. Ability to read, analyze, and interpret technical procedures and governmental regulations.Ability to write standard operating procedures and policy manuals. Ability to apply mathematical operations, tosuch tasks as determination of test reliability, analysis of variance, and correlation techniques

Physical Requirements:

Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. Safety glasses, safety shoes, lab coat, latex or similar gloves, safety apron, organic respirator occasionally.