Associate Director, 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!
The Associate Director is responsible for the development and day to day oversight of Process Development activities and timelines. The AD of PD is accountable for 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. He/She 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. The problem solving, data analysis and interpretation will be focused, data driven and result in thorough documentation and pointed technical reports suitable for executive management.
They will be well versed in internal and external best practices, lead internal and external projects, and be the research expert in interactions with company colleagues. It is expected he/she will continuously improve operational effectiveness and participate actively in the recruitment of technical staff to maintain an effective level of technical ability for all business requirements.
- Lead Process Development training curriculum & ensure trained and effective operators
- Organize activities required for PD operations including but not limited to recruitment, training, scheduling, processing, planning, troubleshooting
- Lead the development effective SOP, protocols, reports, process descriptions and other operational documents, as needed.
- Act as Subject Matter Expert on PD process and procedures
- Provide on-site technical support during critical activities such as scale-up, equipment transfer, process validation and process optimization.
- Work cross functionally with the Analytical and GMP groups to support development and manufacturing processes.
- Conduct briefings and participate in technical meetings with management and clients
- Direct all day-to-day PD operations to ensure delivery of departmental commitments to achieve company objectives
Experience and Skills
- B.S. or M.S. degree in Bio-process Engineering or Bioscience, Microbiology, or other related field with 12+ years of industry experience, or a PhD degree with 8+ years of industry experience.
- Experience with microbiology, anaerobic microbial culture, fermentation, harvest, and formulation is necessary.
- Experience with commercial scale up and cGMP is a plus.
- Ability to independently design experiments, analyze complex data and interpret and present experimental results is required.
PHYSICAL DEMANDS and present experimental results is required.
- 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)