Arranta Bio Associate I, Microbiome Manufacturing Drug Product in Watertown, Massachusetts
The Drug Product Manufacturing Associate I-III will execute the daily cGMP manufacturing operations of solid oral dose drug product manufacturing in Arranta Bio’s state-of-the-art commercial biopharmaceutical manufacturing facility in Watertown, MA. This person is accountable for adhering to the production schedule, while ensuring the highest standards of workplace safety and product quality are adhered to. They will support the Manufacturing Suite startup, procedure generation and training to ensure that the technical transfer, scaleup and commercial manufacturing operations are completed on-time and right the first time. The ideal candidate will enjoy working in a team-oriented environment with minimal supervision.
ESSENTIAL JOB FUNCTIONS
Perform hands-on operations for pharmaceutical manufacturing of solid oral dosage forms, including, but not limited to, dispensing, blending, milling/screening, encapsulation, tableting, banding, coating, weight sorting, packaging, and labeling etc., in a commercial cGMP environment
Perform equipment set-up, break-down, and cleaning, including appropriate care and storage of all change parts
Documentation of all activities in Batch Records, Logbooks, Forms, etc. and electronic interfaces
Maintain the highest standards of workplace Safety and product quality
Follows verbal and written procedures in operating production equipment and performing processing steps; accurately completes appropriate production documentation.
Identifies, escalates, and documents events and deviations and subtle variances that deviate from normal operation; participate as needed in investigations.
Demonstrates ability to troubleshoot basic mechanical operations.
Work in accordance with site and company EHS programs.
Work in accordance with regulations, detailed protocols, Batch Records, SOPs, and Work Instructions
Strong commitment to continuous improvement
High School, Technical Degree Required
B.S. in Biology, or related field preferred
Operational Excellence, such as 6S, experience a plus
Working knowledge of Microsoft Outlook, Word and Excel required.
Good laboratory skills and excellent record keeping, including GDP, is required.
Ability to work independently and stay on task in a fast-paced environment without direct supervision.
Ability to work well with others in a collaborative team environment.
Regular and reliable performance and attendance required.
Ability to handle multiple tasks while remaining focused
Reliable, dependable, and organized
The physical demands described here are representative of those that must be met by anemployee to successfully perform the essential functions of this job. Reasonableaccommodations will be made to enable individuals with disabilities to perform the essentialfunctions.
Employee will be required to move around the work site using pathways/ramps provided
Communicating with others to exchange information
Use of office equipment such as computers, telephones and filing systems will be required to fulfil duties
Ascending or descending ladders
Remaining in a stationary position (i.e., seated or standing if able) for prolonged periods
Adjusting or moving objects between 25lbs-50lbs.
Adjusting or moving objects between 50lbs-100lbs with the assistance of another team member.
Repeating motions that may include wrists, hands and/or fingers.
Operating machinery and/or power tools.
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
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 Agile, Leading, Innovating, Value Creating, and Engaging. Are you ready to come ALIVE with a daring and intrepid team? Don’t wait another minute; Apply today!
Arranta Bio is an Equal Opportunity Employer.
Keyword: Associate I, Microbiome Manufacturing Drug Product
Phone reimbursement policy for qualified individuals
Highly competitive healthcare with many plan options:
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 plan allows for up to a 6% company contribution
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