Manufacturing Associate, Microbiome Drug Product
Arranta Bio is a rapidly growing and dynamic bio-pharmaceutical contract development and manufacturing organization (CDMO). Our vision is to be the best in class CDMO providing development and GMP manufacturing services to microbiome innovators within the pharmaceutical industry. Therapies focused on the human microbiome are exhibiting incredible potential towards revolutionizing disease etiology and associated medical treatments. Arranta Bio’s mission is to build a world class organization which provides microbiome bio-pharmaceutical innovators with a single source of supply from early process development through clinical and commercial GMP finished product.
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.
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!
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. The incumbent 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
Experience and Skills
- High School, Technical Degree OR 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.
- Team player
- Ability to handle multiple tasks while remaining focused
- Reliable, dependable, and organized
- Detail-oriented, excellent written and verbal communication skills required.
- Mechanical / Analytical skills
- Basic Math skills
- Able to understand written or verbal instructions (in English) and execute accurately and independently
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- While performing the duties of this job, the employee is frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear.
- The employee is required to walk; climb or balance; and stoop, kneel, crouch, or crawl.
- The employee must frequently lift and/or move up to 20 pounds and occasionally lift and/or move up to 50 pounds.
- Specific vision abilities required by this job include close vision, and ability to adjust focus.
- No travel required.
- Communicate using telephone and e-mail.
- Phone reimbursement policy for qualified individuals
- Free parking
- Highly competitive healthcare with many plan options:
- Medical (HMO/PPO/EPO)
- 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)