Cell Banking Manufacturing Supervisor

Employer
Arranta Bio
Location
Watertown, MA, United States
Posted
Nov 18, 2020
Ref
85503-311849
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time
ABOUT US

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!

JOB SUMMARY

The Cell Banking Manufacturing Supervisor will supervise daily cGMP manufacturing activities for plasmid products including master cell bank production, final fill operations, as well as upstream, purification, media/buffer production, and general suite/operational readiness activities. The Cell Banking Manufacturing Supervisor is responsible for providing direction, training and development for the Manufacturing Associates I-III and Senior Associates.

ESSENTIAL JOB FUNCTIONS
  • Supervise microbial cell banking and final fill, as well as operations associated with the seed train, fermenter operation, harvest/clarification activity, and purification of plasmid DNA in a commercial cGMP environment
  • Ensure proper documentation of all activities in Batch Records, Logbooks, Forms, etc. and electronic interfaces.
  • Ensure the production schedule is being adhered to by ensuring proper personnel, materials and equipment are available on time.
  • Provide written and verbal updates to Manufacturing Leadership and department managers
  • Maintain the highest standards of workplace Safety and product quality
  • Ensures verbal and written procedures are followed and appropriate production documentation is accurately completed.
  • Identifies, escalates and documents events and deviations from normal operation; active participant in investigations, driving to Root Cause identification and completion.
  • Authors and reviews SOPs and Batch Records, as required.
  • Coordinate activities to ensure validation/revalidation, preventive maintenance programs, training, maintenance and safety programs are met.
  • Meet predefined metrics related to manufacturing and related testing and facility operation.
  • Meet with relevant QA department personnel to coordinate documentation reviews and audits.
  • Strong commitment to continuous improvement
  • Oversee installation, commission, and troubleshooting equipment as needed
  • Interface with manufacturing support groups to align on production requirements


Experience and Skills

EDUCATION AND/ OR EXPERIENCE
  • B.S. in Biology, Chemical Engineering or related field preferred.
  • Minimum of 5 -10 years previous experience in a relevant position in GMP manufacturing in a Biopharmaceutical company.
  • Experience in producing and maintaining Master Cell Banks, as well as Final Fill operations.
  • Operational Excellence, such as 6S, experience a plus 3+ years in a leadership role
  • Working knowledge of Microsoft Outlook, Word and Excel required.
  • Ability to work well with others in a collaborative team environment.
  • Able to work in a rapidly changing climate - reacts well to change
  • Team player
  • Ability to handle multiple tasks while remaining focused
  • Reliable, dependable, and organized


PHYSICAL DEMANDS

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.