Scientist/Senior Scientist Analytical Development and QC - Raleigh

Overview:

Job Summary

This role will require execution of tests inside the Analytical Development laboratory, data analysis, technical report writing.

This role will report to the Director of Analytical Development and QC and will work closely with the other Advanced Medicine Partners functional leads to ensure end-to-end GMP compliance and continuity across the manufacturing and testing network.

Responsibilities:

• Serve as a technical SME and method owner for a subset of assays performed at Advanced Medicine Partners for clients
• Lead and perform analytical development experiments for new partners or platform work for Advanced Medicine Partners
• Support client management as a technical point of contact. Provide technical review of data, protocols, and reports
• Lead Analytical Development projects from design through execution and closure
• Provide training and technical support to all partners involved in the analytical testing network including clients, suppliers, consultants, and internal staff
• Utilize project management tools to help track analytical method development across varying products and laboratories

Qualifications:

• Expertise in biochemistry and molecular biology with focus on methods such as: HPLC, Capillary Electrophoresis, Analytical Ultracentrifugation (AUC), Mass Photometry, Mass Spectrometry
• Understanding of cGMPs and pharmaceutical industry procedures and regulations specifically working with biological drug products.
• Strong laboratory experience and skills
• Experience working in a fast paced, start-up environment
• Strong, open, and transparent communication skills (verbal and written), including excellent presentation skills
• Strong project management and time management skills
• Experience with MS Excel, Word, MS Project, and MS PowerPoint is a plus
• Ability to travel – up to 25%

• Undergraduate degree in chemistry/biology or a relevant science
• Graduate degree preferred, PhD or MS in Biochemistry, Analytical Chemistry or a related discipline
• 7 years of experience in Biotechnology GMP manufacturing in Analytical Development, Research or Quality Control

• Repetitive motion, such as pipetting. Substantial movements (motions) of the wrists, hands, and/or fingers
• Required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; reading labels, signs and small text.
• This position requires the individual to wear and work in personal protective equipment such as lab coat, safety glasses, gloves, and mask (on occasion).
• Required to stand, walk and sit; talk or hear, both in person and by telephone; use hands to finger, handle or feel objects or controls; reach with hands and arms. Regularly required to stoop, kneel, bend, crouch and lift up to 25 pounds.

EEO Statement

Advanced Medicine Partners provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

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