Manager, Process Development
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!
In conjunction with the Head of Process Development, the Process Development Manager is responsible for developing and leading efforts in process development for the development and production of Live Biotherapeutics for clinical use. They will lead in solving complex problems by applying current best technical practices and be able to connect cross-functionally to leverage methodologies used in other fields as well as own. The PD Manager will demonstrate a sense of urgency in the work while maintaining respect for best practices and an understanding for the importance and applicability of quality and controls in development activities.
· Plans, coordinates, and performs the scientific activities of the PD lab
· Works closely with other members of the research team including project leads and scientists across PD as well as other departments to ensure that all programs objectives and requirements are completed in a timely manner
· Provides direct supervision and work flow plan to laboratory personnel
· Provides guidance on the development and execution of protocols as well as the interpretation and review of raw data
· Monitors progress of work by laboratory personnel in relation to established goals and priorities and reviews completed assignments · Coordinates troubleshooting, maintenance, and repair of instrumentation.
· Full understanding of the development process, pharmaceutical industry, and GMP/GLP guidelines
· Good project management and verbal communication skills
· Proficiency in use of Microsoft Word, Excel, PowerPoint and Adobe Acrobat
· Excellent interpersonal and verbal/written communication skills
· Provide leadership on technical strategy and execution from project initiation to internal tech transfer to GMP
· Perform process monitoring, data analysis and data presentation in team meetings
· Author technical development reports, tech transfer documents
Experience and Skills
· B.S. in Biomedical Engineering, Biology or related field with a minimum of 5 years’ experience.
· Prior leadership experience preferred.
· Must have working knowledge culturing anaerobic bacteria
· Must have a working knowledge of microbiological assays and the complexities of evaluating these assays against strict anaerobic bacterial organism
· Must have experience leading programs, personnel leadership experiences
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 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
· The employee will be required to 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)