Drug Substance Manufacturing Supervisor

Pharma Universe


Date: 1 week ago
City: Piscataway, NJ
Contract type: Full time
To support this next phase, we are recruiting for a Drug Substance (DS) Supervisor who will play a critical role in managing the production activities for Biologics Manufacturing for the 3rd shift operation. This includes supervising cell culture fermentation, protein purification, and aseptic processing to produce high-quality drug substances.

Responsibilities

  • A working supervisor position is shift lead.
  • Participate in all drug substance related manufacturing process. Perform (Where needed) and review the process to ensure compliance with the requirements listed in respective batch record.
  • Provides daily supervision on the floor to personnel in the efficient use of equipment and materials to produce quality products under cGMP in accordance with the production plan.
  • Provides coaching, counseling, development, discipline and recognition of direct staff, including performing annual performance reviews.
  • Responsible for maintaining alignment with department direction, goals and objectives.
  • Promotes the use of safe work practices during all production and ensures all external and company policies and EHS standards are met daily.
  • Responsible for training personnel on equipment, processes and Standard Operating Procedures (SOPs).
  • Trains and develops personnel, develops and maintains packaging schedules, and manages within the department budget.
  • Ensures that projects are completed on schedule per established procedures.
  • Participate in execution of qualification and validation activities.
  • Participate in process related investigation(s) and implement CAPA derived from investigation outcome in timely manner.
  • Author and reviews SOPs and other documents to ensure integration of cGMPs and improve process efficiency.
  • Works collaboratively to ensure flow of product, sharing of best practices and lean behaviors.
  • Performs process monitoring, including use of databases, documents and/or spreadsheets to support business reporting requirements.
  • Performs ongoing operational tasks of organization unit, actively assists, or provides direction to subordinates as required.
  • Responsible for final review of completed documentation per compliance standards and establish timelines.
  • Investigates and resolve problems, identifying root cause, and proposing process improvements through clear communication to senior management.
  • Participation and/or leadership role in multi-functional project teams as necessary.
  • Other tasks as requested by management.

Experience/Qualifications

  • Bachelor’s degree, in engineering, pharmaceutical, related life science and at least 5 years of experience
  • Master’s degree, in engineering, pharmaceutical, related life science and at least 2 years of experience
  • Upstream and Downstream manufacturing experience
  • Prior Drug Substance Manufacturing experience
  • Prior aseptic process execution and supervisory experience is strongly preferred.

How to apply

To apply for this job you need to authorize on our website. If you don't have an account yet, please register.

Post a resume

Similar jobs

Registered Nurse - Hospice

Gentiva, Piscataway, NJ
$38.93 - $45.77 per hour
3 days ago
Join us to make a difference when life matters mostWe believe every day is an opportunity to make care more personal and life more comfortable. That’s why we offer personal care, palliative care and hospice to give people the care they need with dignity, grace, and love.  Registered Nurse - PRN - Hospice - 2-3 days per week - Dayshift Compensation...

Upstream Manufacturing Associate

Pharma Universe, Piscataway, NJ
3 days ago
To support further expansion, the Upstream Manufacturing Associate will be responsible for executing mammalian cell culture processes and producing proteins for a wide range of mammalian based biosimilars. The appointed candidate will require technical expertise in Cell Biology and Bioreactor Operations.ResponsibilitiesCollaborate with a dynamic team of manufacturing associates and engineers to carry out upstream production batches.Conduct cell culture and manage...

Warehouse Analyst

Colgate-Palmolive, Piscataway, NJ
$72,400 - $101,500 per year
2 weeks ago
No Relocation Assistance OfferedJob Number #163885 - Piscataway, New Jersey, United StatesWho We AreColgate-Palmolive Company is a global consumer products company operating in over 200 countries specializing in Oral Care, Personal Care, Home Care, Skin Care, and Pet Nutrition. Our products are trusted in more households than any other brand in the world, making us a household name!Join Colgate-Palmolive, a...