Job Title: Scientist
Location: Devens, MA
Duration: 12 months
Pay range: $70 to $75.21/hr on W2
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.
Job 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:
- Work with procurement to identify new suppliers.
- Recommend and/or lead necessary testing to qualify material for use in GMP manufacturing.
- Author technical equivalency assessments, specification comparisons and material characterization reports.
- Support risk assessments.
- Author change controls.
Additional Tasks would include:
- Support material and consumable manufacturing investigations.
- Evaluate and manage material associated supplier changes notifications to maintain GMP compliance.
- 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:
