Supervisor, Microbiome Drug Product 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 Supervisor of Drug Product Manufacturing will supervise the daily cGMP manufacturing operations of drug product manufacturing in Arranta Bio’s state-of-the-art commercial biopharmaceutical manufacturing facility in Watertown, MA. He/She is accountable for adhering to the production schedule, overseeing a team of at least 3 Manufacturing Operators while ensuring the highest standards of workplace safety and product quality are adhered to. The incumbent will provide the leadership, management, and experience necessary to support the Manufacturing Suite startup, procedure generation and training to ensure that the technical transfer, scaleup and commercial manufacturing operations are completed on-time and right the first time.
ESSENTIAL JOB FUNCTIONS
- Supervise all day-to-day Drug Product manufacturing operating to ensure delivery of departmental commitments to achieve company objectives
- Generate and revise internal and external documents (SOPs, BRs)
- Troubleshoot process and equipment problems; Work with Facilities and Validation to maintain manufacturing equipment and escalating when necessary.
- Work closely with production management for current and new manufacturing projects and help develop processes/techniques to meet contract objectives and avoid operational delays
- Interact with clients during initial and subsequent manufacturing campaigns; may be responsible to oversee and escort the person-in-plant (PIP) during manufacturing campaigns
- Ensure staff are fully trained on all cGMP manufacturing operations and documentation and adhering to safety guidelines. Support all planning, scheduling, and production functions to ensure adequate materials, equipment, and personnel are available to meet the production schedule
- Support and enforce a culture of compliance and continuous improvement regarding Safety and Quality
- Ensures Key Performance Indicators are adhered to
- Work with internal stakeholders in manufacturing, drug product and process development, process sciences, project management etc. in support of manufacturing activities
- Focuses on continuous improvement.
- Support all planning, scheduling, and production functions to ensure adequate materials, equipment, and personnel are available to meet the production schedule
- Evaluate the functional strengths and developmental areas in the GMP manufacturing team and focuses on continuous improvement
- Other duties as assigned
Experience and Skills
- Associate degree in a Scientific, Engineering or Biotech field with 4-7 years’ hands on experience with solid oral dose drug product manufacturing under GMP compliance OR
- Bachelor’s degree in a Scientific, Engineering or Biotech field with 3-5 years’ hands on experience with solid oral dose drug product manufacturing under GMP compliance
- Excellent documentation skills including comprehension, review & establishing Batch Production Records, SOP’s, deviation & summary reports
- 3+ years in a Manufacturing/Operations Leadership role, leadership and management experience in a cGMP environment is required
- Experience in oral liquid dose, ointment/gel or sachet drug product manufacturing is a plus
- 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.
- Ability to multi-task, troubleshoot and knowing when to escalate
- The employee is frequently 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.
- 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)