
The role of the Manager, Analytical Chemistry requires knowledge and understanding of scientific concepts, practices, and procedures within the biopharmaceutical field and a cGMP environment. The primary responsibility includes coordinating and supervising routine and advanced laboratory work. The second responsibility is to coordinate with the Managers in the preparation and conduct of study protocols, data analysis, reports and standard operating procedures (SOPs) that support the development and manufacturing activities. As a member of the management team, he or she is expected to contribute to people and departmental growth, budgeting, as well as ensuring a constructive work environment.
General tasks and requirements include: -Provide both technical and management oversight for analytical method development and GMP validation and testing. -Contribute to departmental management for Analytical Development -Coordinate and supervise the completion of routine and advanced assignments by setting work priorities and allocating resources -Coordinates and supervises the preparation and conduct of research protocols and reports -Represent the department in various project meetings and interdepartmental collaborations -Serve in functional roles in the EVMS (Earned Value Management System) if needed -Participate in scientific and technical discussions related to departmental planning, project goals and resource prioritization -Ensure data quality and compliance with cGMP and Good Documentation Practices or equivalent laboratory and documentation practices -Mentor associates to facilitate professional and departmental growth -Manage the IPMP for direct reports -Participates in Emergent Management Development Program -Use sound judgment to resolve problems and make routine and advanced decisions independently -Require good written and verbal communication skills, good team work skills -May require work on weekends and nights Education, Experience, and Skills -A degree (Bachelor to Ph.D.) in a related field with a minimum of 8 years industry experience -Experience in supervising scientists in a cGMP environment -Expertise in one scientific discipline and demonstrated success in applying to a wide variety of practical problems -Demonstrated success in independent judgment, technical proficiency, scientific creativity, collaboration with others in a cGMP environment. -Hands-on experience with one or more assays and instruments: HPLC, FTIR/UV, LC/MS, GC/MS, SDS-PAGE. -Strong technical and communication skills: oral/written and listening -Personal Competencies: Self-awareness, Integrity, Team Player, Creative, and Flexible -Computer skills (MS Office, JMP statistical software, Visio, MS Project) Physical Abilities -Type/keyboard, visual acuity, good eye/hand coordination, stand, walk, sit, twist/turn, climb, reach outward, reach above shoulder, hand dexterity, bend, squat/kneel, sense of feel, sense of hearing, sense of smell, lift/carry 25lbs, pull 25lbs Equipment Used -Phone, copier, computer, copier, hand tools Mental Functions -Organize/coordinate, analyze/interpret, calibrate precise measurements, problem-solve, make decisions, supervise, plan, communicate, prepare written communications, prepare transaction documents Work Environment -Noise above conversation level, hot/cold temperatures, ventilation needed, multiple locations, restricted access laboratory |