Actalent Manufacturing Supervisor in Watertown, Massachusetts
The Manufacturing Supervisor will supervise the daily cGMP manufacturing operations of drug product manufacturing in our state-of-the-art commercial biopharmaceutical manufacturing facility in Watertown, MA. This person will be 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 candidate 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
cGMP, GMP, Manufacturing, Upstream Manufacturing, Downstream Manufacturing, supervisory skills, CDMO
Top Skills Details:
cGMP, GMP, Manufacturing, Upstream Manufacturing, Downstream Manufacturing, supervisory skills
Additional Skills & Qualifications:
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
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
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
Experience in oral liquid dose, ointment/gel or sachet drug product manufacturing is a plus
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
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