Tech Transfer Leader
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!
Arranta Bio seeks a Tech Transfer Leader who brings enthusiasm, intellectual curiosity, scientific rigor, and a desire to help drive novel programs. The candidate must be independent, goal-oriented, flexible, and able to work efficiently across multiple projects. We are searching for enthusiastic, and innovative individuals with a good understanding of upstream and downstream tech transfer biomanufacturing principles.
• 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 Tech Transfers operating including but not limited to manufacturing, manufacturing support, & manufacturing compliance to ensure delivery of departmental commitments to achieve company objectives.
• Lead cross-functional organizational teams in technology transfers from the donating organization (both internal and external) to the Gainesville, FL, based clinical-scale manufacturing facilities.
• Lead project team in developing project and technology transfer strategy for both clinical and commercial drug substance manufacturing campaigns, including process validation, and associated regulatory filings as required.
• Collaborate with cross functional and cross organizational technology transfer partners, both on site and off site to establish project plan timeline with appropriate milestones and resource planning for each project.
• Provide leadership to the project team in the area of risk management, including the assessment, communication, and mitigation of risks associated with the fulfillment of project commitments and plan-of-record expectations.
• Lead technical teams to assess project issues and develop resolutions to meet productivity, quality and client satisfaction goals.
• Manage project stakeholders, both internal and external. Key aspect of this role involves representing projects at relevant site and network governance forums as well as the appropriate product teams within Arranta Bio
• 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
• 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.
• 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+ 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 in a cGMP environment is required
• Experience in fermentation-based manufacturing preferred
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)