Manager, Quality Control (Microbiology)

Employer
Arranta Bio
Location
Watertown, MA, United States
Posted
Sep 23, 2020
Ref
85503-305167
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 Supervisor, Quality Control (Microbiology) will be responsible for establishing the microbiology lab for GMP manufacturing facility. This individual will establish an environmental monitoring program and support the qualification of a bacterial fermentation facility as well as hiring, developing, managing and motivating the QC Microbiology staff. The Supervisor is responsible for the timely and accurate completion of required testing of Environmental Monitoring (EM)/ Clean Utilities, raw materials, in-process and finished products. They assure compliance to GMP and company specifications as well as relevant pharmacopoeia compendia. The Supervisor identifies areas for continuous improvement and/or implementation of industry best practices and drive implementation in the laboratory. The Supervisor keeps laboratory management informed of all departmental activities and product related events.

ESSENTIAL JOB FUNCTIONS
  • Establish an Environmental Monitoring program
  • Support facility and utility qualification
  • Generates and approves SOPs and test methods
  • Supervises daily activities of QC Microbiology Analysts and assures that job activity deadlines are met on a timely basis.
  • Hires and oversees the training of QC department personnel.
  • Assures execution of monitoring and testing programs to assess the quality of raw materials, components, in-process and finished goods, environmental systems/utilities systems and effectiveness of production processes.
  • Ensures that raw materials, components, products, or monitoring results that do not meet specifications or expectations are promptly investigated. Identifies possible source and corrective action needed and evaluates the impact upon the product.
  • Identifies adverse microbial quality trends by preparing and analyzing Environmental Monitoring summary reports.
  • Mentors and develops new department personnel including training in Standard Operating Procedures and On The Job Training (OJT).
  • Investigates and resolves non-conforming test results by completing thorough Deviation, OOS/OOT, and Laboratory Investigation Reports.


Experience and Skills

  • B.S. in Microbiology (or equivalent degree) and 5-10 years of relevant and progressive experience working in Quality Control Microbiology, with 1-2 years of supervisory experience.
  • Familiarity with Good Manufacturing Practices (cGMP's) and pharmacopeial compendia along with having experience in cGMP cleanrooms.
  • Have the knowledge and ability to apply advanced scientific and regulatory principles to solve operational, as well as routine quality tasks.
  • Self-starter with the ability to produce results in a fast-paced environment to meet client deadlines under minimal supervision.
  • Experience with viable and non-viable Environment Monitoring collection instruments, techniques and qualifications/validations.
  • Document writing, data interpretation, presentation, statistical analysis and trending a plus.
  • Positive, professional attitude toward work and willingness to cooperate with co-workers and supervisors and to contribute to a project team.


PHYSICAL DEMANDS
  • This will be a laboratory-based position that will require some non-standard working hours including early morning or later evening teleconferences to support current clients
  • 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 occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl.
  • The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.
  • Specific vision abilities required by this job include close vision, and ability to adjust focus.
  • In the performance of the duties of this job the employee is not required to travel but will communicate using telephone and e-mail.


BENEFITS

Arranta Bio is an Equal Opportunity Employer.