Lab Manager, Quality Control
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!
This position is responsible for organizing and ensuring the successful in-process, and release testing of raw materials, in-process, release, and stability samples. The ideal candidate will be an innovative leader with strong of experience in QC lab operations. The lab manager is also responsible for maintaining the integrity of work areas including maintenance and calibration of equipment, general work center safety and cleanliness in compliance with established Quality standards.
- Communicate and enforce laboratory quality requirements to all personnel working in the lab and ensure that they are completed per GMP requirements.
Lead 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.
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.
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 adverse microbial quality trends by preparing and analyzing Environmental Monitoring summary reports.
Experience and Skills
EDUCATION AND/ OR EXPERIENCE
- B.A. or B.S. degree in scientific field or related science discipline
A minimum of 5-7 years related experience with biological products in a QC lab
A minimum of 1 year of supervisory experience.
Must have experience with cGMP and quality systems including OOS investigations, deviations, change control and CAPAs.
Requires excellent written and oral communication skills.
High attention to detail, excellent organizational skills and the ability to work on multiple projects with tight deadlines.
Demonstrated ability to work independently as well as a strong contributor in a cross functional team environment on complex projects.
Skilled at analyzing data, summarizing results, and generating performance metrics to drive corrective actions
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 inspire and foster innovation, collaboration, transparency and team effectiveness
Ability to manage timelines and coordinate work schedules of employees
Direct supervisory experience strongly preferred
- 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.
- 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)