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 Manager / Sr. Supervisor / Supervisor of GMP Manufacturing will direct the GMP manufacturing in Arranta Bio’s state-of-the-art commercial biopharmaceutical manufacturing facility in Gainesville, FL. He/She is accountable for building, maintaining, and continuously improving a highly effective cGMP production workforce, driving activity to achieve the desired departmental, site, and company outcomes, and ensuring the highest standards of workplace safety and product quality are adhered to. The Manager / Sr. Supervisor / Supervisor of GMP Manufacturing provides direct leadership for the GMP Manufacturing team and is a key value stream leader for customer projects providing both technical and operational leadership and expertise. The incumbent will provide the leadership, management and vision necessary to ensure that the company has the proper controls, KPI, people, and systems in place within the manufacturing function.
- Establish programs, practices, and processes to drive a high-performance culture and engaged workforce across Safety, Quality, Delivery and Cost
- Direct all day-to-day plasmid manufacturing operating including but not limited to manufacturing, manufacturing support, & manufacturing compliance to ensure delivery of departmental commitments to achieve company objectives
- Direct all planning, scheduling, and production functions to ensure adequate materials, equipment, and personnel are available to meet the production schedule
- Encourage and enforce a culture of compliance and continuous improvement regarding Safety and Quality
- Develops and implements Key Performance Indicators to track and lead successful, timely achievement of goals, objectives, and projects
- Maintains departmental operational and capital budget, responsible for driving financial results, drives optimization of fixed and variable cost
- Work with internal stakeholders in manufacturing, process development, process sciences, project management etc. to facilitate successful project and customer management
- Provide leadership and direction to ensure Inspections, Deviations, Change Control, CAPAs and Regulatory commitments are met on time with the highest standards of quality.
- Develop a robust training program/strategy
- Develop and maintain operational excellence programs, such as 6S
- Collaboration & goal setting with all other organizations at the site including PD, QA, QC, etc.
- Make decisions, based on the professional judgment, experience, budget, cGMP regulations, and the ethical guidelines of good business practices.
- Evaluate the functional strengths and developmental areas in the GMP manufacturing team and focuses on continuous improvement.
- Must stay current with relevant technologies and forward thinking to identify new approaches
Experience and Skills
EDUCATION AND/ OR EXPERIENCE
- B.S. and/or M.S. in Biology, Biochemistry, Chemistry, Engineering or related field
- 5-10 years hands on experience in biotechnology/pharmaceutical manufacturing practices, guidelines, management practices, cGMP knowledge, and production and planning operations.
- 5+ years in a Manufacturing/Operations Leadership role, leadership and management experience in a cGMP environment is required
- Experience in fermentation-based manufacturing and/or Drug Product manufacturing including lyophilization.
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.
- 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 required to travel occasionally, drive a motor vehicle.
- 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)