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Process Engineer, Drug Substance

Company: Cambrex
Location: longmont
Posted on: May 3, 2021

Job Description:

At Cambrex, it's our people that set us apart. We work locally and have an impact globally. We're committed to attracting, nurturing and retaining a passionate and talented team of experts in our fast paced and growing company. You will be valued and recognized. We offer an exceptional benefits package including medical, dental, vision, Life, STD, LTD, generous vacation in your first year, sick time, and retirement savings! Cambrex is the small molecule company that provides drug substance, drug product and analytical services across the entire drug lifecycle. Known for our scientific and manufacturing excellence and customer focus, we offer a range of career opportunities across our global network of locations. As a team, we share one goal - to improve the quality of life for our customers' patients across the world.

Overview

The position will be responsible for coordinating projects through the Drug Substance manufacturing area working with multiple departments to ensure projects are executed on time. The candidate will be responsible for ensuring process are fit-for-purpose prior to scaling, including process feasibility and safety assessments of operations and chemical reactions to be conducted in the small-scale manufacturing suites. The individual will be responsible for the creation and review of cGMP manufacturing batch records to introduce early phase drug substance into the Drug Substance Facility. The ideal candidate will have hands-on experience with chemical handling, manufacturing equipment, and an understanding of the chemistry being performed. Experience working with cGMP and quality systems, SOP preparation, report writing, equipment qualification and knowledge of FDA, EU, and ICH requirements and their implementation in the pharmaceutical industry.

Responsibilities

* As a Drug Substance Process Engineer you will coordinate with cross-functional teams during the onboarding and development of projects slated for drug substance manufacturing. * The DS Process Engineer will assist the manufacturing chemists during the technical transfer process. This will include process safety needs, process feasibility, identifying equipment needs, equipment cleaning requirements and strategies, and implementation of the identified considerations. * You will assist the manufacturing chemists in maintaining departmental timelines and tracking deliverables (both internal and external) to maintain production schedules. * You will be responsible for writing batch records and other quality documents (change control, CAPA, deviation, etc). * You will be responsible for SAP updates and execution of products in SAP. * You will be called upon to support problem solving of technical issues pertaining to drug substance manufacturing. * You will be responsible for bringing in new equipment, as needed, for projects and assisting to execute the qualification for specific equipment. This entails change control initiation and closure, SOP writing and equipment qualification execution. * You will support the creation technical documents and reports. * You will be responsible for attending client meetings and interacting with clients pertaining to drug substance manufacturing. * Additionally, you will adhere to all applicable procedures, cGMPs, company policies, and any other quality or regulatory requirements.

Qualifications

* Bachelor's Degree with 5+ years of applicable experience or Master's Degree with 2+ years of applicable experience. Degree in Chemistry or Chemical Engineering degree a PLUS. * Experience in small molecule manufacturing and process development required. * Experience interfacing with external customers * Experience in CDMO industry preferred. * Experience with SAP a plus. * Knowledge of FDA, EU, and ICH requirements and their implementation in the pharmaceutical industry required. * Experience with cGMP documentation (MBRs, change control process, CAPAs, etc.) needed.

Keywords: Cambrex, Longmont , Process Engineer, Drug Substance, Other , longmont, Colorado

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