Responsibilities

• Responsible for review internal and external process documents
• Utilize good biologics process understanding to determine process fit and gap analysis
• Generate Bill of Material (BOM) for either USP or DSP operations
• Prepare batch records for engineering and cGMP batch execution
• Develops and maintains key relationships with Process Development scientists to effectively communicate and participate in project discussions.
• Help to resolve routine process issues and support GMP manufacturing activities
• Perform other duties as assigned

Requirements

• Bachelors
• Excellent knowledge and direct experience of protein-based biologics manufacturing processes
• Strong technical writing and spoken communication skills
• Good understanding what internal and/or external customers need
• A team player who contributes to a positive work environment

Responsibilities

• Responsible for performance/training of bioburden, endotoxin, TOC, and conductivity testing.
• Performs laboratory housekeeping to ensuring proper maintenance of the microbial lab, which includes maintaining inventory
• Cooperate in lab investigations such as OOS and deviation investigations
• Assist with validation of microbial lab equipment
• Other duties as assigned.

Requirements

• Undergraduate degree or AA degree
• Essential coursework includes microbiology with microbiology lab
• 0-3 years of industry experience in microbiology
• Demonstrate knowledge of aseptic technique.
• Familiarity with use of a computer (e.g., Proficient in Windows, Microsoft Word, Excel, and statistical software (such as GraphPad or Minitab)
• Good written and verbal skills
• Strong critical thinking/problem solving skills

Responsibilities

• Develops, interprets, and implements quality control policies and procedures, and supports regulatory compliance inspections.
• Work within Quality team and interface with key stake-holders to maintain regulatory-compliant quality control operations.
• Work with clients and internal AD group for testing methods transfer and set product specifications.
• Work with clients and internal staff to ensure all QC tests remain in a compliant state, and final product meets all required standards and specifications.
• Manage the environmental monitoring program to ensure the manufacturing facility is in compliance of regulatory requirement.
• Ensuring data integrity compliance with the current Regulatory Guidance for all QC Quality Systems in Quality Control Operations.
• Proficient in industry standard operations for analytical method qualifications based on phase-appreciate cGMP guidelines.
• Work with Analytical group and ensure the smooth internal transfer of analytical methods and is responsible for continuous improvement to address outdated software, equipment, and methodology.
• Work with regulatory group to author and review relevant sections of an IND application and provide technical responses.

Requirements

Responsibilities

• Lead and manage a team of scientists/engineers focused on downstream purification process development activities. Provide leadership to resolve purification investigations and technical issues in the process development and manufacturing areas.
• Establish and maintain familiarity with contemporary industrial practices and technology focused on purification process development. Manage day-to-day laboratory operations, including prioritizing samples and studies, scheduling analyst assignments, and tracking timely progress of critical samples and studies to support project timelines. Provide reports on department output that evaluate operating effectiveness.
• Provide strategic leadership in resource allocation and prioritization of analyses to assure alignment of department objectives and timely execution of experiments to support clinical development programs.
• Motivated to drive operational excellence, including support for efficiency/productivity initiatives, and GxP/safety compliance.

Requirements

• Doctorate (Ph.D.) degree in chemical engineering, bioengineering, biochemistry, biotechnology, biology, , or a related field, with at least 2 years of industrial experience is preferred. B.S./M.S. with at least 5 years of industrial experience are also considered.
• Demonstrated ability to lead teams, including cross-functional initiatives & strong ability to foster a collaborative work environment.
• In-depth understanding of methodology and data interpretation in separations sciences and processes.
• Expert in purification technologies from lab to manufacturing scale, in operating chromatography equipment such as Akta or filtration equipment, and in application of statistical/DOE tools for process development and data analysis.
• Excellent communication and people management skills.
• Ability to execute studies and experiments in the context of supporting long-term commercialization plans

Responsibilities

• Independently perform unit operations in one or more of the following areas:
  • Cell Culture: including cell banking, culture scale-up, bioreactor operations, filtration, media prep, process monitoring, centrifugation
  • Purification/Formulation: including column chromatography (ProA, SEC, CEX, AEX), filtration, TFF, buffer prep, bulk filling
  • Fill/Finish: including filtration, component prep, buffer prep, aseptic processing and filling, visual inspections
• Independently document work per cGMPs, adhere to all applicable regulatory and safety standards.
• Independently assemble, standardize, prepare, clean and operate process equipment.
• Independently perform process monitoring, daily analyses, and maintenance of analytical equipment
• Support validation activities including IQ/OQ/PQ of process equipment and processes
• Execute SOPs and batch records, revise and/or author new procedures as appropriate
• Maintain work areas to meet cGMP requirements
• Train on all area procedures, maintain up-to-date training records, and perform training of peers as needed
• Adjust work schedule to meet production demand, which may include overtime.
• Individual work shifts will likely include regular weekend work.

Requirements

•  Associate/Bachelor’s degree in science or engineering, or biotech certificate or equivalent
• Experience in a biotech/pharma manufacturing environment is preferred for Manufacturing Associate I, and required for Manufacturing Associate II or III.
• Team player, must have the skills and ability to work in a collaborative environment
• Excellent communication and documentation skills

Requirements

• Must possess strong technical and analytical understanding of Biologics Manufacturing and testing. Ability to clearly communicate compliance strategy and rationale via oral and written communication techniques.
• Knowledge of scientific principles and concepts as they relate to Operations and GMP.
• Knowledge of CAPA, change control and deviation programs and requirements.
• Great team player who is collaborative and positive.
  Ability to understand and apply GMP regulations as they relate to manufacturing, test laboratory and facility operations.
• Demonstrates ability to effectively manage multiple tasks utilizing organization and prioritization skills, self-motivated.
• Strong interpersonal, written/oral communication and problem-solving skills.
• Knowledge of GMP regulations and understanding of FDA and other regulatory guidelines.
• Proficiency in IT systems and software.
• Strong analytical and problems solving skills.
• Ability to professionally express views and opinions.
• Good listening skills and ability to accept conflicting point of views.
• Strong organizational skills with attention to detail. Ability to navigate different personality styles in a large, complex organization in a professional manner. Ability to juggle multiple priorities.
• Strong leadership principles and deliver result in line with expectations.