Associate Director - Drug Product, Microbiome Manufacturing
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 for Drug Product Manufacturing is responsible for the development of a multi-year drug product manufacturing strategy at Arranta Bio. The AD of Drug Product will enable Arranta Bio to have the leading drug product clinical and commercial Drug Product capability by 2024 including but not limited to the implementation of new drying technologies and finished product processing operations technology. The AD of DP is accountable for building, maintaining, and continuously improving a highly effective cGMP production 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 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 manufacturing function.
ESSENTIAL JOB FUNCTIONS
- Lead Drug Product training curriculum development & ensuring trained DP manufacturing operators in Florida and Massachusetts
- Organize operational activities required for GMP Drug Product manufacturing operations in MA including but not limited to recruitment, training, scheduling, processing, etc.
- Lead the development effective SOP and batch record and other operational documents, as needed.
- Act as Arranta’s Subject Matter Expert on oral dose manufacturing
- Provide on-site technical support during critical production activities such as scale-up, equipment transfer, process validation and process optimization.
- Support the development of a multi-year drug product manufacturing strategy to enable Arranta to have the leading drug product clinical and commercial Drug Product capability by 2024 including but not limited to the implementation of new drying technologies and finished product processing operations technology
- Work cross functionally with the Analytical and Drug Substance Process Development and Drug Product development groups to support scale up of Drug Product manufacturing processes.
- Conduct briefings and participate in technical meetings with management and clients
- Direct all day-to-day Drug Product manufacturing operations including but not limited to manufacturing, manufacturing support, & manufacturing compliance to ensure delivery of departmental commitments to achieve company objectives
- Other duties as assigned
Experience and Skills
- B.S. and/or M.S. in Biology, Biochemistry, Chemistry, Engineering or related field
- 8+ years hands on experience in biotechnology/pharmaceutical manufacturing practices, guidelines, management practices, cGMP knowledge, and Drug Product Operations
- 5+ years in a Manufacturing/Operations Leadership role, leadership and management experience in a cGMP environment is required.
- Ability to work by influencing peers and their reports and gain their cooperation.
- Ability to see the "big picture" while being capable of driving detailed, tactical execution.
- A high sense of urgency and a commitment to delivering results is essential.
- 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)