Manufacturing Chemist I OR II

Published
May 10, 2022
Location
Longmont, CO
Category
Job Type

Description

Overview

Cambrex is seeking a Manufacturing Chemist I or II to join our team. This position will be responsible for executing GMP and non-GMP manufacturing production of intermediates and drug substances. This position is responsible for writing and executing batch records, reviewing SOPs and quality documents associated with manufacturing, and maintaining a safe working environment.

Responsibilities

- Performs and executes scale-up activities for large scale non-GMP/GMP manufacturing projects, including familiarization and front run execution - Performs laboratory scale experiments in support of non-GMP/GMP manufacturing projects - Reviews GMP documents (Batch records, SOP's, etc.) according to regulatory and procedural guidelines - Coordinates the activities of manufacturing technicians - Works with Manufacturing management and Quality to resolve manufacturing problems - Develops and maintains quality documents in support of manufacturing (CAPA's, Change Control, Unplanned Changes, etc.) - Independently writes batch records from tech transfer documents (including notebook pages) from the batch record template. - In conjunction with Process chemistry, evaluates incoming processes for scalability during the tech transfer process. - Independently determines proper equipment configurations and process flow during drug substance manufacturing. - Represents the manufacturing team during multidisciplinary internal project meeting for one or more projects. - Provides written and verbal manufacturing updates to the client. - Writes campaign summary report for one or more projects. - Reviews executed batch records performed by other team members. - Participates in safety evaluations prior to manufacture. - Trains other manufacturing personnel in safe and efficient manufacturing operations. - Other duties as assigned

Qualifications

Mfg Chemist I- B.S. with 2+ years of experience or M.S. with 1+ years of experience. Or equivalent. Mfg Chemist II- B.S. with 5+ years of experience or M.S. with 3+ years of experience. Or equivalent.   The following considerations are a plus: - Good/Strong knowledge of GMP for API, Drug Product and Drug Substance - Good/Strong knowledge of HPLC, GC, NMR, and other methods of compound characterization - Good/Strong working knowledge of organic chemistry and how it applies to drug substance Manufacturing - Experience with FDA audits preferred. The hiring range in Colorado for this position is $56,000-$76,000; however, base pay offered may vary depending on job-related knowledge, education, skills and experience of the applicant, internal equity, and alignment with market data. This hiring range encompasses several levels. This information is provided per the Colorado Equal Pay Act. This position includes a competitive benefits package.   Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.   #cb #LI-LS1

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