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AstraZeneca · 1 month ago

Associate Scientist IV, Clinical QC Analytical Development & Clinical QC

US - New Haven - CT

Full-time

Onsite

Senior Level

7+ years exp

AstraZeneca is a biopharmaceutical company focused on the development of innovative medicines. The Associate Scientist IV will be responsible for clinical stability, inventory, and sample management for GMP activities, as well as performing experimental tasks to support compendial testing of manufacturing processes.

BiopharmaBiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine

Comp. & Benefits

H1B Sponsor Likely

Responsibilities

Working in a demanding environment where product development supports unmet needs of patients with rare diseases

Responsible for cGxP operations in support of early stage - PIII biologics

Perform all job functions in compliance with cGXPs and maintain accurate and legible laboratory records

GMP shipping and handling support for incoming shipments, receipt, inventory, sample management and gLIMS data entry

Clinical Stability laydown and sample aliquoting of drug substance and drug product material (bulk bag, vial, PFS, AI etc) for testing

Oversee and document all Laboratory Investigations (EQV) for Clinical QC

Manage the batch release and stability testing certificates (CoA/CoT)

Assist the compliance team with change controls, deviations, CAPA’s

Supervise and lead subordinates as needed

Ensure compliance to legal regulations and company policies

Represent Clinical QC-ADQC on cross departmental project teams and provide technical input as required

Perform testing for in-process, drug substance and drug product release and stability samples (i.e., Compendial: Protein Concentration, Appearance, pH, freeze-point/ vapor-pressure Osmolality, sub-visible particulate (LO) and device functionality testing as assigned.)

Aid in experimental studies, developing, optimizing, qualifying, or supporting manufacturing processes or analytical/characterization methods for biotherapeutic candidates

Write and review methods, SOPs, qualification and validation protocols and reports, and technical reports as assigned

Compile data and information related to assay and instrument performance

Recognize aberrant test and sample conditions and report to them to the area supervisor / manager

Maintain knowledge of current scientific principles and theories and train other lab personnel as assigned in areas of competence

Order, stock, and receive, label, log, and inventory laboratory supplies

Provide laboratory support services, clean/maintain equipment and prepare reagents/solutions

Ensure training is current for all job functions performed. Attend all required Company training

Review laboratory data and documentation as qualified and assigned by area management

Perform other related duties as assigned

Global role requiring domestic and international travel (up to ~5%)

Qualification

GMP knowledgeBiological ChemistryAnalytical methodsVeeva Vault ECMSGLIMSLean 6 SigmaTroubleshooting skillsCommunication skillsOrganizational skills

Required

A BS degree in Immunology, Biochemistry, Chemistry, Chemical Engineering, or related discipline from an accredited university

7+ years of relevant experience or equivalent combination of education and experience is required

In depth knowledge of GMPs and their application in the environment is needed

The individual in this position is expected to have an in depth understanding of the Biological Chemistry laboratory environment and be familiar with all laboratory equipment / instrumentation, procedures, and responsibilities

Understand and follow written procedures when conducting experiments and applying methods

Ability to document procedures and data in peer-reviewed laboratory notebooks and/or LIMS

Able to organize his/her own work on a routine basis and requires minimal supervision. When asked, the individual can provide updates and tracking on his/her tasks

The ability to communicate verbally and in a written format is required

The ability to troubleshoot assays and instruments in area of expertise, and to offer solutions, is expected

Communicate findings to colleagues within the group through presentations

The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours

Preferred

Experience with Veeva Vault ECMS, ELN, gLIMS, Lean 6 Sigma

Experience with domestic and international shipping requirements

Company

AstraZeneca

Glassdoor4.1

AstraZeneca is a pharmaceutical company that discovers, develops, manufactures, and markets prescription medicines. It is a sub-organization of Investor.

Founded in 1999

Cambridge, Cambridgeshire, GBR

10001+ employees

https://www.astrazeneca.com

H1B Sponsorship

AstraZeneca has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2021 (2)

2020 (11)