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Fill Finish GMP Manufacturing Associate II

Vigene Biosciences, A Charles River Company Rockville, MD, USA

Employment Type

Full-Time

JOB TITLE: Fill Finish GMP Manufacturing Associate II

DEPARTMENT: GMP Manufacturing

REPORTS TO: Manager, GMP Manufacturing

LOCATION: Rockville, MD (5-Research)

General Job Description

Vigene Biosciences has been a leader at the forefront of cell and gene therapy, Adeno-Associated virus or AAV vector production, adenovirus vector production, lentivirus vector production, retrovirus vector production, plasmid production, viral vector QC and analytical services, plasmid QC and analytical services, providing services and products to support this rapidly growing and increasingly important field.

The Fill Finish Manufacturing Associate II applies a broad knowledge of biological, bioprocess, and mechanical principles to execute complex operations that result in clinical and commercial stage medicines to dramatically improve the human condition through gene therapy.

Duties and Responsibilities

  • Perform basic to complex activities in dispensing of Drug Substance and Fill-Finish of Final Drug Product
  • Follow verbal and written procedures in operating production equipment and performing processing steps, accurately complete appropriate production documentation
  • Document all activities in Batch Records, Logbooks, Forms, etc.
  • Effectively communicate and interface with team to ensure the completion of daily activities.
  • Work in cleanroom environment while adhering to Standard Operating Procedures (SOPs)
  • Prepare buffers and solutions to support Fill-Finish operations as needed
  • Perform other tasks as assigned that ensures sustainable right-first-time performance and delights customers
  • Perform preparation of buffers at large scale (>20L)
  • Edit and review Production Batch Records and Standard Operating Procedures
  • Perform other tasks as assigned that ensures sustainable right-first-time performance
  • Demonstrate ability and understanding of Safe working habit and Material Safety Data Sheet (MSDS)
  • Other responsibilities as needed

Qualifications for the Job

  • High School Diploma or Associate Degree with 3-7 years of experience in Fill-Finish operations in Biopharmaceuticals Manufacturing Industry; or
  • Bachelor of Science with 2-4 years of experience in Fill-Finish operations in Biopharmaceuticals Manufacturing Industry
  • Technical understanding of Fill-Finish operations for biologics products, including aseptic process simulations and qualifications
  • Hands-on experience with manual and semi-automated filling apparatus
  • Hands-on experience in large scale (≥ 20L) buffer preparation
  • Organizational and planning skills
  • Ability to work in a Team and collaborative environment
  • Attention to detail and time management
  • Previous work in viral or vaccine production highly desired
  • Previous experience working for a Contract Manufacturing Organization (CMO) preferred
  • Communication skills (writing, speaking, comprehending)
  • Basic computer skills including Microsoft (Word, Excel, Teams etc.)
  • Ability to work in a fast-paced environments

Key Competencies

  • Demonstrate integrity and respect
  • Delivers results
  • Demonstrates business acumen
  • Champions change
  • Engages and inspires

Working Conditions

  • Ability to work with hazardous waste and laboratory chemicals
  • Operations are 24 hours per day, 7 days per week, and shift work will be required
  • Must be able to gown and pass gowning qualification to work inside a cleanroom for at least 4 consecutive hours
  • Must be able to work flexible hours – must be willing to work outside of normally-scheduled hours as necessary
  • Must have reliable transportation to travel between sites in Rockville area
  • Standing, (sometimes prolong standing), sitting, pushing, pulling, walking, bending, stooping, kneeling, and must be able to lift up to 50 lbs.

Vigene Biosciences, Inc. is an equal employment opportunity employer and does not discriminate against any applicant on the basis of race, color, religion, sex, sexual orientation, gender expression and identity, national origin, ancestry, age, mental and physical disability, genetic information, any veteran status, military status or application for military service, or membership in any other category protected under applicable law.

COVID-19 considerations:
We have established multiple policies to protect our employees' health & safety while allowing essential operations to continue following social-distancing & PPE guidelines.