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Arranta Bio Supervisor, Microbiome Manufacturing Drug Product in Watertown, Massachusetts

Job Descriptions:

JOB SUMMARY

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. This person 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. They 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

  • Focus 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

  • Supervise day-to-day Drug Product manufacturing to ensure delivery of departmental commitments to achieve company objectives

  • 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

Required Experience:

  • 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

PHYSICAL DEMANDS

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 will be made to enable individuals with disabilities to perform the essential functions.

  • Employee will be required to move around the work site using pathways/ramps provided

  • Communicating with others to exchange information

  • Use of office equipment such as computers, telephones and filing systems will be required to fulfil duties

  • Ascending or descending ladders

  • Remaining in a stationary position (i.e., seated or standing if able) for prolonged periods

  • Adjusting or moving objects between 25lbs-50lbs.

  • Adjusting or moving objects between 50lbs-100lbs with the assistance of another team member.

  • Operating machinery and/or power tools.

MEDICAL REQUIREMENTS

COVID19 Vaccine required to come on site; Individuals seeking an exemption from this requirement for medical or religious reasons should reach out to Human Resources for an accommodation

Specific Vision Requirements:

  • Color vision

  • Ability to adjust focus

  • Close vision

ABOUT US

Arranta Bio is a visionary contract development and manufacturing organization (CDMO) that partners with companies seeking to develop and manufacture complex biological drugs and innovative therapies. Our dedicated team, state-of-the-art facilities, and unparalleled resources are crucial for advancing products from development to commercial launch. Our vision is to be the trusted and innovative CDMO partner for advanced therapy pioneers, so that we can bring life-changing therapeutics to patients. We partner with our clients to make treatments that can benefit vast patient populations, working across many indications. Arranta Bio’s mission is to change healthcare through our intrepid and daring team engaging with clients to develop, manufacture, and supply breakthrough therapies that transform lives. Arranta Bio continues to expand capacity and development and manufacturing services across multiple sites with technology platforms designed to meet the evolving demands of our clients and partners.

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. Are you ready to come ALIVE with a daring and intrepid team? Don’t wait another minute; Apply today!

Arranta Bio is an Equal Opportunity Employer.

Keyword: Supervisor, Microbiome Manufacturing Drug Product

BENEFITS

  • Phone reimbursement policy for qualified individuals

  • Free parking

  • Highly competitive healthcare with many plan options:

  • Medical (HMO/PPO/EPO)

  • Dental

  • vision

  • 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 plan allows for up to a 6% company contribution

  • 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)

From: Arranta Bio

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