Job Description: *
ABOUT US*
Arranta Bio is a visionary contract development and manufacturing organization (CDMO) that partners with companies seeking to develop and manufacture complex biological drugs and innovative therapies. Our dedicated team, state-of-the-art facilities, and unparalleled resources are crucial for advancing products from development to commercial launch. Our vision is to be the trusted and innovative CDMO partner for advanced therapy pioneers, so that we can bring life-changing therapeutics to patients. We partner with our clients to make treatments that can benefit vast patient populations, working across many indications. Arranta Bio’s mission is to change healthcare through our intrepid and daring team engaging with clients to develop, manufacture, and supply breakthrough therapies that transform lives. Arranta Bio continues to expand capacity and development and manufacturing services across multiple sites with technology platforms designed to meet the evolving demands of our clients and partners.
WHO ARE WE
Arranta hires people who are committed and passionate to the goal of bringing life enhancing products to patients. We want top talent who will render ideas and a relentless desire towards accomplishing our mission; when a job becomes a passion, it makes you feel ALIVE.
Here at Arranta Bio, we embrace ALIVE - our core values that we live and breathe daily! We are A*gile, Leading, Innovating, Value Creating, and E*ngaging.
We embrace our challenges as opportunities.
We are empowered to think and act.
We never settle; we strive to improve through purposeful creativity.
We build aligned teams who learn, grow, and deliver.
We are committed to building strong relationships.
Are you ready to come ALIVE with a daring and intrepid team? Don’t wait another minute; Apply today!

JOB SUMMARY
This position is responsible for organizing and ensuring the successful process of sampling and testing raw materials to support cGMP manufacturing processes. The ideal candidate will be a detail oriented cross functional leader, with technical expertise in raw material testing.
ESSENTIAL JOB FUNCTIONS

• Subject matter expert in raw material sampling and testing.
• Oversee raw material sampling and testing.
• Establish raw material testing SOPs and Test methods.
• Manage the workflow of requesting materials through submission of results to QA group for release.
• Communicate and enforce laboratory quality requirements to all personnel working in the lab and ensure that they are completed per GMP requirements

• Create, analyze, verify, and approve data, results, reports, and certificates of analysis

• Generate, revise, review specifications, SOPs, and other QC lab and testing documents

• Support Out of Specification and Deviation investigations related to the QC laboratory and ensure corrective actions are developed and implemented

• Lead and facilitate initial and periodic training of QC analysts to ensure adherence to laboratory practices, techniques, and GMP requirements

• Interact with auditors/clients during visits and tours
• Prepare and perform personnel evaluations and competency development and administer performance reviews.

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Required Experience: *

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B.S. degree in scientific field or related science discipline

• A minimum of 3-6 years related experience with biological products in a QC lab
• Experience with QC raw material testing, including setting of raw material specifications.
• Demonstrated ability to work independently as well as a strong contributor in a cross functional team environment on complex projects.
• Strong work ethic with ability to meet rapidly evolving and dynamic business priorities
• Possess the ability to proactively adapt to rapid changes in business priorities and foster teamwork among employees to maintain high quality standards
• Ability to drive functional, technical, and operational excellence
• Ability to inspire and foster innovation, collaboration, transparency, and team effectiveness
• Ability to manage timelines and coordinate work schedules of employees
• Experience with setting up processes related to FTIR analysis, and establishing raw material libraries.

PHYSICAL DEMANDS

• Ascending or descending ladders
• Moving self in different positions in various environments including tight and confined spaces
• Remaining in a stationary position (i.e., seated or standing if able) for prolonged periods
• Adjusting or moving objects weighing up to 25lbs
• Adjusting or moving objects between 25lbs-50lbs.

MEDICAL REQUIREMENTS
COVID19 Vaccine required to come on site; Individuals seeking an exemption from this requirement for medical or religious reasons should reach out to Human Resources for an accommodation

BENEFITS

• Phone reimbursement policy for qualified individuals
• Free parking
• Highly competitive healthcare with many plan options:

• Medical (HMO/PPO/EPO)

• Dental
• vision

• Flexible Spending Accounts for medical expenses and dependent care expenses
• Up to 10 weeks of 100% paid maternity leave
• 2 weeks of 100% paid paternity, domestic partner, & adoption leave
• Educational assistance program
• 401k (traditional and Roth offered) with 100% match on first 5% deferred.
• A suite of Arranta Bio paid insurance coverage, including life insurance, short-term and long-term disability
• Voluntary legal assistance plan
• Employee Referral program
• Competitive PTO plan, in addition to 10 company paid holidays (includes 2 floating holidays)

From: Arranta Bio

Job Type: Full-time