job summary: As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Focusing on immune diseases like HIV that affect a large percentage of the population, the work our longtime partner conducts is imperative to a better, healthier future. To be recognized as a crucial part to furthering this goal, join this growing team now!
location: King Of Prussia, Pennsylvania
job type: Contract
salary: $27.16 - 31.95 per hour
work hours: 9 to 5
responsibilities: Job Responsibilities
- Responsible for process technology transfer from Bioprocess development groups to GMP Operations.
- Conducts facility fit assessments and leads process introduction activities for downstream unit operations.
- Monitors technical operations of the process through communication with Manufacturing Scientists.
- Coordinates activities between Development groups.
- Represents the Process Technology department at multi-disciplinary matrix teams.
- Presents results/conclusions at these meetings.
- Responsible for successfully troubleshooting production problems and for the technical success of multi-million dollar biopharmaceutical production campaigns that support progression of the Biopharm R&D portfolio.
- Participates in quality investigations and continuous improvement projects.
- Responsible for ensuring that manufacturing campaign data and supporting information is sufficient to support regulatory packages and filings.
- Authors manufacturing and process sections of regulatory submissions and responses to regulatory questions.
- Responsible for authoring and approval of batch documentation.
- Conducts batch planning activities, such as raw materials management and/or water runs.
- Provides training and guidance to Manufacturing Scientists and less experienced personnel.
- Develops, evaluates, and supports industrialization and introduction of technologies essential to large-scale cGMP production.
- Highly visible position with above average level of accountability.
- Failure of a large scale cell culture/fermentation or purification processes has ramifications throughout the research, development, and clinical organizations.
- Monitors processes in Downstream Purification.
- Collects information and prepares/maintains a campaign summary database of process knowledge, to be leveraged as assets progress in the biopharmaceutical development cycle.
- Analyzes results fully and recommends follow-up actions.
- Leads troubleshooting activities.
- Ensures that processes being transferred and supporting documentation are sufficient to support consistent production and regulatory filings. Conducts facility fit analysis and coordinates process introduction activities.
- Prepares and/or approves documents for use in technology transfer and manufacturing. Authors documents for regulatory purposes.
- Progresses the industrialization of technology essential to large scale cGMP production. Solves process and equipment problems. Recommends equipment and procedures. Keeps aware of new technology developments. Technically expert in purification technologies and unit operations.
- Coordinates activities between various Biopharmaceutical Development and Supply groups (i.e. project teams, formulations, quality, analytical, development, validation, engineering, etc). Represents the Process Technology department in project teams and other multi-disciplinary matrix teams. Presents results/conclusions and contributes to the decision-making process within these teams.
- Provides support for technology transfer into Manufacturing Operations.
- Prepares and approves GMP documentation including master batch records.
- May play a leadership role for specific cGMP compliance/readiness projects (i.e., coordination of process scheduling, facility/equipment changeover).
qualifications: Education & Qualifications
- Ph.D. in chemical engineering, biochemical sciences, or related engineering/scientific disciplines with a minimum two (2) years relevant experience, or M.S. in these disciplines with a minimum four (4) years relevant experience, or B.S. in these disciplines with a minimum of six (6) years of relevant experience in the following areas:
- Lab/pilot scale protein purification methods including chromatography, ultrafiltration, depth filtration, centrifugation and buffer preparation.
- Proficient in cGMPs and regulatory requirements.
- Proficient in technology transfer and process scale-up.
- Excellent troubleshooting/problem analysis skills. Experience with Lean Sigma and Root Cause Analysis methodologies highly desirable.
- Excellent written and oral communications skills.
- Excellent organizational, collaboration, and teamwork skills.
- Strong interpersonal and leadership skills. Solid team player able to function within collaborative- and team-based organization.
- Experience in project management and delivery, including ability to prioritize and forward plan courses of action.
- Works independently with minimal to no direct supervision.
skills: GMP (Good Manufacturing Practice), Manufacturing Operations
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.