GMP Manufacturing Associate

Precigen, Inc; Germantown (MD); Vor Ort; USD 70.000 - 85.000; Vollzeit

Zusammenfassung

Precigen, Inc. in Germantown, MD is seeking a GMP Manufacturing Associate I/II to join a dynamic cGMP biology manufacturing team. You will perform manufacturing for clinical and commercial materials with careful attention to detail and strict SOP adherence.

The ideal candidate holds a biology or life sciences degree and has 1–3 years of GMP experience; aseptic technique and familiarity with MBRs are important. Weekend and shift work may be required to meet production goals.

Qualifikationen

• Bachelor's or Master's degree in biology or life sciences.
• 1–3 years of GMP manufacturing experience for Associate 1; 3+ for Associate 2.
• Aseptic technique experience is required.
• Knowledge of cGMPs and GMP processes.
• Prior cell culture and/or purification experience preferred.

Aufgaben

• Perform GMP manufacturing for clinical and commercial materials.
• Assemble raw materials.
• Execute Master Batch Records (MBR) under cGMP.
• Follow SOPs, MBRs, deviations and summary reports.
• Support deviations initiation and closure.
• Assist in cleaning and changeover of clean room suites and equipment.
• Participate in technology transfer.
• Work in cross-functional teams to complete production tasks.
• Adhere to safety and regulatory requirements; occasional weekend/shift work.

Kenntnisse

GMP manufacturing

Aseptic technique

cGMP compliance

Team collaboration

Ausbildung

Bachelor's degree in biology / life sciences

Master's degree in biology / life sciences

Tools

GMP equipment operation

MBR processing

SOPs and deviations handling

Jobbeschreibung

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

GMP Manufacturing Associate

Full-time Regular Associate - STAFF Germantown, MD, US

30+ days ago Requisition ID: 1425

Salary Range: $70,000.00 To $85,000.00 Annually

GENERAL DESCRIPTION:

GMP Gene Manufacturing Associate I/IIwill require a professional who thrives in a dynamic team environment, brings meticulous attention to detail in the quality of their work and is proactive in implementing improvements. This position will perform a broad range of tasks in the cGMP manufacturing of clinical and commercial adenovector products. Prior experience in GMP manufacturing and operation of GMP process equipment are required.

DUTIES AND RESPONSIBILITIES:

• Perform manufacturing for clinical and commercial materials in GMP setting, including, but not limited to:
• Assembling raw materials
• Execute Master Batch Records (MBR) under current Good Manufacturing Practices (cGMPs.)
• Following and assisting in the development of specific standard operating procedures (SOP), MBRs, deviations and summary reports for manufacturing
• Support initiation and closure of deviations
• Support routine cleaning and changeover procedures for clean room suites and equipment
• Participating in and facilitating technology transfer
• Work in a team based, cross-functional environment to complete production tasks.
• Adhere to all safety and regulatory requirements while performing job functions.
• This position requires occasional weekend and shift work.
• Other duties as assigned.

EDUCATION AND EXPERIENCE:

• Bachelor's degree or master degree in biology, biomedical science or life science
• Minimum of one to three (1 – 3 for Associate 1, 3+ for Associate 2) years in a GMP environment required
• Aseptic technique experience is required.
• Knowledge in principles and practices of current Good Manufacturing Practices (cGMPs)
• Prior cell culture and/or purification experience in a GMP facility is preferred.

DESIRED KEY COMPETENCIES:

• Comfortable in a fast-paced company environment and able to adjust workload based upon changing priorities.
• Self-motivated and willing to accept temporary responsibilities outside of initial job description and perform other responsibilities to support the needs of the department, as assigned.
• Positive interpersonal skills.
• Outstanding knowledge, and ability to apply scientific principles utilized to solve operational, as well as routine production tasks
• Ability to troubleshoot unit operations.
• Self-organizer, meticulous hands-on habits, keen attention to detail.
• Ability to manage multiple and varied tasks and prioritize workload
• Prior Tangential Flow Filtration (TFF) experience is preferred.
• Occasional work outside of normal business hours, including evenings, weekends, and holidays, may be required based on business needs.