Target Hiring Date
July 14, 2025
Work Authorization
Applicants must have the legal right to work in the United States without requiring sponsorship. Corp-to-Corp (C2C) arrangements are not accepted.
Requirements
EDUCATION:
Degree in Biology, Chemistry, Biochemical or Chemical Engineering, or equivalent area of related experience in biologics upstream manufacturing.
QUALIFICATIONS:
Prior experience in/knowledge of cell culture is a must.
The candidate must have demonstrated verbal, written, and communication skills including ability to present complex information clearly and concisely, with a successful proven history of working with technical teams.
Experience should include management of lab activities, technical support of a cGMP manufacturing facility, including strong knowledge and engineering leadership for viral vector manufacturing and processing equipment, and process characterization.
Prefer experience with leading experiments and designing DOEs.
Prior experience in/knowledge of cell culture, viral vector manufacturing, recovery and/or purification of viral vector product in a manufacturing environment preferred.
Prior experience with SOPs, cGMPs and how they are applied within a regulatory environment required.
Prior experience participating in process characterization preferred.
Preference given to candidates with experience performing process characterization.
Knowledge of cellular immunology and/or vector manufacturing a plus.
Experience with cGMP, ICH guidelines, PPQ (process validation), control strategy development, and working within a Quality organization.
Proficiency utilizing MS Office products and working knowledge of statistical software (R, JMP, Minitab).
Experience working in a self-driven, performance/results oriented, fast paced matrix environment.
Experience writing experimental plans and protocols.
WORKING CONDITIONS:
Position requires repetitive use of hands and wrist (computer work), and infrequent lifting of items not to exceed 50 lbs.
Occasional bending, twisting and stooping to allow for gowning into classified environment required.
Position will require time in the office and lab.
Position is a team & project-based position that will require occasional shift work, weekends, and holidays.
About the Role
The Assistant/Associate Scientist/Engineer to join our Vector and Gene Delivery MS&T group in GDPAD. The successful candidate will design and execute experiments related to supporting commercial vector manufacturing processes. This person will collaborate across all CMC functional areas to insure project advancement, rapid and best in class execution, and communication of challenges/opportunities.
DUTIES AND RESPONSIBILITIES:
• Oversee lab activities and schedule.
• Design studies to support commercial manufacturing deviation investigations.
• Support the the execution of process characterization studies.
• Collaborate with commercial vector team to identify opportunities for process improvements, make formal recommendations.
• Lead identification and implementation of new technologies and procedures from Development into Manufacturing.
• Lead efforts focusing on alignment and harmonization of manufacturing process across multiple sites.
• Support the hands-on training of commercial process unit operations to Vector MS&T.
• Identify, design and manage small capital engineering projects.
About the Company
Join Sokol GxP Services – Where Innovation Meets Integrity!
Join Sokol GxP Services, where we partner with leading pharmaceutical and biotech companies to provide exceptional Commissioning, Qualification, and Validation (CQV) services. We are committed to fostering diversity, empowering local talent, and building strong community connections to bring the best-qualified candidates to our clients in the Summit, NJ area. Our inclusive and collaborative culture promotes growth and innovation.
Let’s shape the future of life sciences together!
Our benefits:
• health insurance,
• 401(k),
• paid holidays,
• UTO.
All applicants will receive an acknowledgement that their application has been received within 2-3 weeks from the from the date of receipt.
Equal Opportunity Employer Statement:
Sokol GxP Services is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
By submitting your application and resume, you consent to have your information retained in our repository for six months. This allows us to consider you for future opportunities that may align more closely with your skills and qualifications. If a suitable position becomes available, we will contact you directly.