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 Media Prep / Cleaning Manager will manage essential support activities for our Manufacturing and Process Development teams in the preparation of all media and buffers, and in the cleaning and sterilizing of glassware, consumables and cGMP Manufacturing Rooms. The Manager will be accountable for building, maintaining, and continuously improving a highly effective cGMP media prep and cleaning 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 provides direct leadership for the Central Services Department 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 Central Services function.
• Establish programs, practices, and processes to drive a high-performance culture and engaged workforce across Safety, Quality, Delivery and Cost
• Manage all day-to-day media/buffer prep and cGMP disinfection operations, including but not limited to manufacturing, manufacturing support, & manufacturing compliance to ensure delivery of departmental commitments to achieve company objectives
• Manage 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.
• 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
• B.S. and/or M.S. in Biology, Biochemistry, Chemistry, Engineering or related field
• Minimum of 5+ years hands on experience in biotechnology/pharmaceutical manufacturing practices, guidelines, management practices, cGMP knowledge, and production and planning operations.
• Operational Excellence, such as 6S, experience a plus
• Excellent documentation skills including comprehension, review & establishing Batch Production Records, SOP's, deviation & summary reports
• Good laboratory skills and excellent record keeping, including GDP, is required.
• Ability to work well with others in a collaborative team environment.
• Ability to handle multiple tasks while remaining focused
• Reliable, dependable, and organized
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)