Scientist

Pay rate: $75.21

Job Description: Work location: Devens, MA
Onsite/hybrid: 50% onsite (Tue, Wed, Thurs). First month will need to be onsite every day.
Work hours: 40 hours, Core hours are 9:00 - 4:00

Top 3 to 5 Skills or Must haves:
Demonstrated Technical Writing Ability
Worked in Cross matrix Teams
Project Management - fast paced environment and can manage multiple projects at once
Independent Contributor - personable and can work with multiple stakeholders
Change Controls - GMP environments preferred
Investigation Experience
Bio Pharma experience preferred

Scientist, Global Capabilities MS&T Materials and Cryogenics Science

Description:

The Scientist in Manufacturing Sciences & Technology will support the Materials and Cryogenics Science group in the life cycle management of raw materials, consumables and single-use systems utilized for biopharmaceuticals commercial manufacturing operations. The successful candidate will collaborate closely with Manufacturing, Manufacturing Technology, Quality Assurance, Quality Control, Supply Chain, and Global Procurement groups on cross-functional teams.

The subject matter expert for this position will be primarily required to:

Qualify alternative raw material suppliers:
o Work with procurement to identify new suppliers
o Recommend and/or lead necessary testing to qualify material for use in GMP manufacturing
o Author technical equivalency assessments, specification comparisons and material characterization reports
o Support risk assessments
o Author change controls
Additional Tasks would include:
o Support material and consumable manufacturing investigations
o Evaluate and manage material associated supplier changes notifications to maintain GMP compliance.
o Support material specification development

Requirements:

Minimum BS/MS with 2+ years of industry experience post-graduation or PhD in Material Science Engineering, Chemistry or equivalent scientific background.
Awareness of cGMP compliance and regulatory agency requirements.
Demonstrated problem solving ability (familiarity with root cause analysis techniques and CAPAs a plus)
Strong organizational, oral communication and technical writing skills
Effective team player and strong individual contributor
Familiarity with analytical techniques (FTIR, SEM-EDS, etc.)
Knowledge of data trending and tracking, including use of statistical analysis software a plus

Travel requirements: No

Physical requirements: No
Additional Job Requirements:
Lab w/o blood & animal