Specialist, Engineering (Onsite)
About The Position
The Formulation, Laboratory, and Experimentation (FLEx) Center is a new multi-modality (small molecule, biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical supply manufacturing facility in Rahway, New Jersey. The Sterile Process Engineer role at the Specialist level will leverage the individual’s leadership, technical, and communication skillsets to drive the success of our clinical manufacturing facility and organization. As the facility is nearing the completion of its’ Process Simulation execution, the selected candidate will lead and contribute to the launch and regulatory certification of the facility startup and operational readiness activities. This role will have extensive leadership potential as the first representative of our team on second shift. Once the facility is operational, this role will support the pipeline’s most technically complex formulations and process development through process tech transfer, scale-up activities, quality investigations, change management, and authoring GMP standard operating procedures and protocols in support of sterile clinical drug product operations. This individual will collaborate closely with the formulation scientists, engineers, operations staff, quality representatives, and other team members to ensure the quality of the clinical supplies, the scientific rigor of the processes, and ultimately to enable the flexibility and speed of our Company's pipeline. The role is, on-site, based in New Jersey and reports to the Sterile Process Engineering Lead of the FLEx GMP facility within Pharmaceutical Operations and Device Development (PSDD).
Requirements
- Bachelor’s degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of 3 years relevant experience OR Master’s degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field.
- Excellent enterprise leadership skill demonstration
- Excellent interpersonal and communication skills, both verbal and written.
- Experience in leading quality investigations and change management.
- Familiarity with United States and European Union GMP and Safety compliance regulations.
- Ability to convert new drug product attributes and process needs to an executable series of steps and procedures to enable acceptable product manufacture.
- Ability to prepare Standard Operating Procedures (SOP) and current GXP documents.
- Experience with quality systems.
- Excellent organizational skills.
- Desire and willingness to learn, contribute and lead.
- Track-record of independent problem-solving.
Nice To Haves
- Experience with sterile GMP facility operations.
- Knowledge of Investigational drug regulatory requirements.
- Understanding of Clinical Supply Chain Operations.
Responsibilities
- Lead and contribute to the launch and regulatory certification of the facility startup and operational readiness activities.
- Support the pipeline’s most technically complex formulations and process development through process tech transfer, scale-up activities, quality investigations, change management, and authoring GMP standard operating procedures and protocols in support of sterile clinical drug product operations.
- Collaborate closely with formulation scientists, engineers, operations staff, quality representatives, and other team members to ensure the quality of the clinical supplies and the scientific rigor of the processes.
- Drive the success of the clinical manufacturing facility and organization.
Benefits
- medical, dental, vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays, vacation, and compassionate and sick days
- annual bonus and long-term incentive, if applicable
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
