Job Title - Scientist ll, Drug Product Development
Work Location - Cranbury NJ
Job SummaryDrug product process development (DPD) is seeking a scientist to join our department. The successful candidate will be expected to work as part of a ream that is focused on the activities including but not limiting to formulation development, drug product manufacturing process development and technical transfer, clinical in use compatibility study, and drug product manufacturing support. Work closely with analytical sciences (AS) and process development and drug product manufacturing teams to lead formulation development projects. Responsible for study design, execution and troubleshooting to meet client project deliverables. Author technical documents including SOPs, protocols, study reports, etc.
Responsibilities- Understanding of the drug product manufacturing processes and scaling up
- Understanding of the liquid formulation development and fill/finish process scale up
- Develop formulation for biologics to support stability including study planning, design, execution and author study reports to manage the DPD project life cycle.
- Develop analytical methods focusing on separation assays, biophysical characterization using techniques such as chromatography, mass spectrometry, electrophoresis, spectroscopy, and binding assays.
- Develop injectable drug product manufacturing process including container closure selection, drug product compatibility with manufacturing process, and provide tech transfer and manufacturing support including deviation investigation and trouble shooting.
- Author technical documents including SOPs, protocols, study reports, and support regulatory filing.
- Play an important role in Formulation/DPD lab maintenance efforts including, equipment selection/procurement, data integrity audits, lab supply management, authoring documentation and supporting the team building activities.
- Apply scientific knowledge and experience to assigned projects. Interface extensively in a matrixed environment with process development, analytical development and manufacturing teams for process investigation support, assess new formulation/DPD technologies, support on-going and upcoming client projects.
- Communicate effectively on the findings of research and development internally and externally to ensure alignment among WuXi Biologics and with clients.
Preferred:- Drug product process development experience with large molecules for parenteral administration
- Development and characterization of aseptic fill and finish operations including freeze/thaw, compounding, mixing, sterile filtration, filling, stoppering, visual inspection,
- Manufacturing experience of biologics drug product in clinical settings.
- Experience in biophysical characterization of the biologics drug products.
Qualifications- PhD with 0-2 years of experience in Pharmaceutics, Pharmaceutical Sciences, Pharmaceutical Chemistry or Chemistry Candidate.
- Knowledge in formulation development, high concentration protein formulation, matching placebo development, and drug product process development areas. Understand current industry practice and scientific reasoning for biologics product formulation development.
- Strong communications skills. Great team player and ability to build positive collaboration with internal stakeholders, vendors and clients to achieve alignment and work effectively.
- Must work in a self-motivated, multiple tasks, highly flexible, well-organized and detailed-oriented style.
- May require some evening work hours and conference call time to meet global team time zones.
- The job description does not intend to list all the duties and responsibilities assigned to this position. Employee holding this position would be required to perform other job-related duties/responsibilities based on their expertise and company business needs.
The Anticipated salary for this position is $66,200 - $105,900
