Senior Research Associate, Analytical and QC

PhaseBio Pharmaceuticals

Malvern, PA, US
  • Job Type: Full-Time
  • Function: Research Sci/Assoc/Mgr
  • Post Date: 06/03/2021
  • Website: phasebio.com
  • Company Address: 1 Great Valley Parkway Suite 30, Malvern, PA, 19355

About PhaseBio Pharmaceuticals

PhaseBio is a clinical-stage biopharmaceutical company committed to developing new and improved drugs, with an initial focus on endocrine and metabolic disorders and cardiovascular disease.

Job Description

The patient is at the heart of what we do.

PhaseBio is developing specialized, highly innovative therapies for patients with serious cardiovascular diseases. We are determined to overcome the lack of new treatment options for cardiovascular disease and provide superior outcomes for patients and healthcare systems. Driven by high-quality science, we leverage our team’s deep expertise to rapidly develop and commercialize our pipeline of unique medicines.

 

Title: Senior Research Associate, Analytical and QC

Department: CMC & Preclinical

Report to (title): Sr Mgr, Analytical QC

Location: Malvern, PA

Supervisory Responsibility: No

Travel Required: No

Position Type: Full-Time

FLSA Status: Exempt

Expected Hours of Work: (include any mandatory meeting times with time zone) ~40 hrs/week

 

Summary/Objective

The Senior Research Associate, Analytical and QC performs sample testing and assay development independently and in collaboration with others on assays used for characterization of protein therapeutics and performs GMP testing to support lot release and stability programs.   

 

Description

Essential Duties and Responsibilities

  • Perform protein characterization testing using a variety of biochemical, immunological, and molecular biology techniques such as ELISA, SDS-PAGE, Western blot, HPLC, etc.
  • Perform cell-based potency testing under GMPs.
  • Perform lot release and stability assays under GMP conditions to support early and late phase clinical studies.
  • Perform in-process testing to support Manufacturing Science and Technology (MS&T)
  • Perform method qualification/validation studies according to established protocols.
  • Author, review and implement Standard Operating Procedures for laboratory operations/methods, equipment, and Analytical QC systems SOPs; author deviation, investigation, and CAPA reports.
  • Train new analysts on existing QC methods and participate in training to support the transfer of new methods into the Analytical/QC or contract testing laboratory.
  • Perform data analysis and stability trending/ assay performance summaries, review assay records and laboratory notebooks.
  • Troubleshoot and optimize methods with minimal supervision. Point out assay issues and make recommendations for improvement of assays and systems.
  • Manage sample shipments for testing performed at multiple contract testing laboratories.
  • Ensure the accuracy and timeliness of all laboratory-related processes.
  • Maintain equipment and execute equipment qualifications, as needed.
  • Maintain a GMP compliant Analytical /QC laboratory including ordering, inventory management, and initiation of work orders. Provide high-quality documentation of all lab-related activities.
  • May be required to assist in other departments as needed. 

 

Qualifications Requirements

  • B.S. or M.S. in the Biological Sciences, Analytical Chemistry, or related with 5+ years of experience in a Research or pharmaceutical setting. (please apply even if you have a combination of education and experience otherwise which makes you qualified) 
  • Some experience in a GMP, GLP or CLIA environment expected.

 

Tools and Technology Used

  • Microsoft Office 365 (Word, Excel, PowerPoint, Teams, Outlook…)
  • DocuSign and Adobe
  • MasterControl
  • Lab Equipment

 

Work Environment & Mental and Physical Requirements

  • This job operates primarily in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and other common office equipment and accessories.
  • Lab Environment
  • Ability to remain in a stationary position; move; operate and use required equipment; and reach items
  • Ability to move/transport up to 30 lbs., and up to 50 lbs. occasionally.
  • Ability to communicate, converse with others, and exchange information

 

EEO Disclaimer

PhaseBio is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to any protected characteristic protected by federal, state, or local laws. If you require a reasonable accommodation in completing this application, interviewing, completing any pre-employment requirements, or otherwise participating in the employee selection process, please direct your inquiries to the HR Department by calling the PhaseBio main line at 610-981-6500.

 

Applicants have rights under Federal Employment Laws:

 

Other Disclaimers

Please note this description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required. It is subject to change at any time.

 

This job description does not constitute an implied or express contract for employment and does not guarantee employment.  Employment is at-will.

 

We are not able to sponsor visas. PhaseBio is not an E-Verify employer and therefore cannot employ OPT individuals.

 

PhaseBio does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company or to this posting without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific.

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.