QC Scientist II

Position Summary :

Join a high-impact, GMP testing analytical team as a member of the Quality Control (QC) Analytical department. Modalities include monoclonal antibodies, peptides, and other recombinant proteins. This position leads : Contract Testing Laboratory (CTL) management, extensive cross-functional communications, the implementation of control charts, the compilation of testing for batch release, and authorship of certificates and laboratory investigations in a contract manufacturing facility.

Additionally, this individual will be a subject matter expert (SME) in the sampling, release testing, and management of the aforementioned produced biologics to support the daily activities involved in compliant testing, training, and audit readiness. This individual must be able to interface effectively with management personnel and SMEs across analytical, manufacturing, engineering, and quality teams.

Must have a strong biochemistry background in biopharmaceutical analytical testing and understand cGMP standards and requirements. Must have excellent critical thinking and troubleshooting skills, the ability to analyze, interpret, and present complex data with conclusions and understanding of impact to the product. This role requires excellent writing skills with full grasp of grammar, spelling and style rules, and compliance with quality standard guidelines and factual accuracy.

Responsibilities include :

• Product Testing : In-process and release testing as assigned; techniques include (but not limited to) HPLC, SDS-CGE, ELISA, qPCR, SoloVPE, and compendial testing per USP
• Solution preparation
• Analysis and collation of data to draw conclusions
• Trend analysis using control charting
• Drafting method transfer protocols
• Drafting method transfer reports
• Execution of method transfer, method qualification, and / or method validation testing under protocol
• Independently authors or reviews lab investigation and deviation reports
• Develops and / or owns and implements Corrective and Preventive Actions
• Tracks and / or implements department metrics; actively engages in improvement of department metrics
• Ensures state of safety and regulatory audit readiness at all times
• Participates in data review activities, as needed
• Ensures Trainer qualification status to expand team matrix
• Laboratory support
• It is the expectation that this position is required to be onsite full time with a minimum of 75% of time in the laboratory / facility

Position Requirements :

For QC Scientist II position : B.S. degree and 8 years of related experience; M.S. degree and 6 years of related experience; Ph.D. in a specific discipline and 2 years of related experience. Able to react to change productively and handle other essential tasks as assigned. Adheres to all safety requirements and assures that departmental employees comply with required safety procedures.

Able to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.

Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs, etc.) in its most difficult phases. Ability to deal with a variety of abstract and concrete variables.

Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.

Posting range : $101,000.00 / yr - $138,000.00 / yr

Salary : $101,000 - $138,000