VP of Process Development- Watertown, MA
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 VP of Process Development directs all facets of plasmid process and analytical development for Arranta Bio at our newly constructed best-in-class Watertown, MA facility. He/She should be proficient in state-of-the-art techniques for plasmid design and characterization, microbial fermentation, DNA purification, and related assays, instrumentation, and manufacturing technology to support development of robust, scalable, plasmid manufacturing processes. He/She is a scientific leader in microbial fermentation of biologics and its application in the manufacture of plasmid DNA. The VP of Plasmid Process Sciences provides direct leadership for the Plasmid Process Sciences organization, is a member of the Site Leadership Team, and is a key value stream leader for customer projects. He/She is accountable for working within and continuously improving a highly effective workforce and system, 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.
ESSENTIAL JOB FUNCTIONS
- Build and lead a team of proficient plasmid process and analytical development staff (PhD and non-PhD) to support a multi-product/customer development organization
- Design, plan, and execute experiments to develop, understand, and characterize processes for production of Plasmid DNA
- Lead plasmid process characterization (e.g. establishing CQAs, CPPs) ativity
- Lead and oversee all process and analytical transfers and technical project plans to and from internal and external business partners.
- Own and execute Quality by Design (QbD) for programs * Support the commercial function in the assessment of new opportunities and provide appropriate Technical and programmatic input to prospective customers, including the demonstration of capability at customer visits.
- Evaluate the functional strengths and developmental areas in the Process Sciences team and drive a culture of continuous improvement.
- Independently review the design, execution, data and reporting on the development work completed within the Process Science group. Is expected to resolve (or have resolved) all technical issues.
- Instill scientific rigor and enhance process knowledge across all Watertown operations
- Key input into the development of manufacturing platforms and novel technologies
- Responsible for the development schedule adhering to appropriate level of documentation, budget, schedule, and safety commitments
- Other duties as assigned.
Keyword: Process Sciences; biologics; manufacturing
- Ph.D. in biochemical engineering, biological sciences, or relevant field with 10-15 years experience required
- Solid foundation in the fundamentals of biochemical engineering and cell biology.
- Entrepreneurial experience dealing with customers in product development.
- Working knowledge of cGMPs related to the production of microbial therapeutics.
- Ten to fifteen years of development and scale-up experience.
- Experience with microbial fermentation technologies, protein and DNA purification, DNA characterization, and downstream processing are essential.
- Ability to work by influencing peers and their reports and gain their cooperation in dealing with multiple priorities in the delivery of projects.
- Strategic leadership and conceptual thinking to ensure that a cost-effective organization is put in place and developed.
- Rational persuasion particularly in the discussions with customers.
- Strong people management and organizational skills; ability to prioritize and manage through complex processes/projects.
- Ability to interpret and manipulate data, define problems, establish facts, draw valid conclusions, and make decisions.
- Ability to deal with abstract and concrete variables in situations where only limited standardization exists.
- Extremely high levels of initiative and tenacity.
- Excellent oral and written communication skills
- 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.
From: Arranta Bio