Downstream Manufacturing Associate IV

Position Summary

Reporting directly to the Upstream/Downstream Supervisor, Manufacturing, the Manufacturing Associate IVwill be responsible for supporting the cGMP manufacturing processes while adhering to Standard Operating Procedures (SOPs) and regulatory guidelines in a controlled cleanroom environment.

An ideal candidate must have strict attention to detail, high-quality customer service skills, and the ability to work well and collaborate in cross-functional teams.

Key Responsibilities

• Supports daily manufacturing responsibilities for clinical and commercial manufacturing programs.

• Executes and documents batch records in compliance with current Good Documentation Practices.
• Revise and review SOPs, batch records, and other documentation to support manufacturing.
• Microbial fermentation and/or Mammalian cell culture in Upstream/Downstream processing as follows:
  1. Upstream knowledge and experience with the following:
     • Bacterial fermentation and Mammalian single-use systems up to 1000L
     • Continuous flow centrifuges
     • Homogenization and depth filtration operations
     • Single-Use temperature-controlled mixing systems
  2. Downstream knowledge and experience with the following:
     • Bench-scale to Large-scale filtration systems including Tangential Flow Filtration (TFF) and depth filtration
     • Bench-scale to Large-scale Chromatographic (AKTA) and HPLC systems (Agilent)
     • Packing and evaluating columns
     • Drug Substance Bulk fill or vial fill and aseptic handling techniques

• Support deviation and CAPA resolution with SME and quality teams.
• Provide input and support to MSAT/PD during development and scale up activities as necessary.
• Support facilities in ensuring proper functionality of the equipment calibration and preventative maintenance as part of the equipment control program.
• Maintain company and client confidentiality.
• Communicate safety policies and goals and ensure team members adhere to facility safety policies.

Education & Experience

Requires an Associate’s, BS or MS from an accredited college or university with major coursework in a Scientific or Engineering discipline.

• Experience working in a GMP manufacturing environment is essential.
• Manufacturing processes in microbial systems is highly desirable.
• Requires 6+ year (AS/BS), or 5+ years (MS) of biomanufacturing experience.
• Requires a strong background in cGMP principles and Quality Management Systems.
  

Knowledge & Skills

• Excellent verbal and written communication skills; strong presentation skills as this role requires the ability to communicate and connect with all levels of the organization.
• Analytical ability, both interpersonal and issue-related; good judgment and ethics; professional presence and demeanor.
• Must possess good to excellent writing and PC skills with a knowledge base in Microsoft Word, Excel, PowerPoint, and Project.
• Must maintain a working knowledge of commercial cGMP’s and phase-appropriate cGMP’s as they apply to various phases of clinical and commercial manufacturing.
• Must obtain a working knowledge of current global regulatory requirements and guidelines and perform within all Standard Operating Procedures (SOPs) and policies.
• Outstanding interpersonal skills: ability to build strong relationships with cross-functional team members and lead through influence.
• Ability to take responsibility and “get the job done” in a high-energy, high-intensity, results-oriented environment.

Physical Requirements and Working Environment

• Flexibility is required for working hours. Some weekend work may be needed and earlier or later start/finish times may also be required.
• Must be able to be fully gowned in cleanroom attire and be able to stand for an extended time.
• The essential functions of the job are usually performed in an environmentally controlled facility where the noise level in the work environment is usually moderate. This position may involve a combination of office and laboratory environments and automated equipment.
• While performing the job duties, the employee is regularly required to sit; reach with hands and arms and talk or hear. The employee is frequently required to stand and walk. The employee may sometimes be required to lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, and the ability to adjust focus. The employee must have manual dexterity and manual ability to effectively use computer terminals.