Sr. Scientist, Analytical/QC Details

Sr. Scientist, Analytical/QC

PhaseBio - Malvern, PA

Employment Type : Full-Time

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: Sr. Scientist, Analytical/QC

Department: CMC & Preclinical

Report to (title): Sr. Dir. Analytical Dev. & QC

Location: Malvern, PA

Supervisory Responsibility: No

FLSA Status: Exempt

Position Type: Full-Time

Travel Required: Occasional

Expected Hours of Work: ~40

Benefits: https://phasebio.com/careers/

Summary/Objective

This person will be responsible for developing separation and other biophysical methods, assay transfers, technical problem solving, data review, biochemical characterization of products, and quality control sample testing as appropriate.

Description

Essential Duties and Responsibilities

• Develop or optimize analytical methods and write method SOPs
• Oversee analytical method development at contract labs
• Oversee analytical method transfer to contract labs
• Perform characterization testing of PhaseBio products
• Train QC analysts on separation methods
• Review PhaseBio and contract lab data
• Perform QC testing of PhaseBio samples as needed

Secondary Duties and Responsibilities

• Write analytical sections of INDs and BLAs
• Oversee maintenance of some instruments and provide expertise on instrument use
• Provide assistance in resolving instrument and assay problems

Qualifications Requirements

• Preferred 5+ years of experience in pharmaceutical analytical development or quality control lab (please apply even if you have less years of experience and qualify otherwise)
• Expertise with HPLC and electrophoresis methods with some knowledge of spectrophotometry and mass spectrometry
• Experience with product characterization or quality control testing of proteins
• Small molecule analytical experience a plus
• Thorough understanding of Good Manufacturing Practice
• Good oral and written communication skills
• Some experience with writing documents for health authorities preferred

Education, License, Certification, or Preferred Qualifications

• MS in Analytical Chemistry, Biochemistry or related, PhD preferred.

Tools and Technology Used

• Microsoft Office 365 (Word, Excel, PowerPoint, Teams, Outlook…)
• DocuSign and Adobe
• A variety of analytical laboratory instruments such as HPLC, spectrophotometer, mass spectrometer, capillary electrophoresis and related software

Work Environment & Mental and Physical Requirements

• Must be capable of working in laboratory dealing with protein products and sensitive analytical instruments
• Organized, methodical and strong problem-solving abilities
• 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.
• 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:

• EEO is the law poster: https://www.dol.gov/sites/dolgov/files/ofccp/regs/compliance/posters/pdf/eeopost.pdf
• Employee Polygraph Protection Act poster : https://www.dol.gov/sites/dolgov/files/WHD/legacy/files/eppac.pdf

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 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.