Company DescriptionProPharma Group is an industry leading, single source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle for pharmaceutical, biotechnology, and medical device companies. Operating around the world with offices in Australia, Canada, Germany, Japan, the Netherlands, Sweden, United Kingdom, and the United States, ProPharma Group’s fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today’s dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes.
Job DescriptionOur client requires a Senior Process Engineering Support Consultant for a 6-month, fully-remote project opportunity with their Rensselaer, NY facility. This project position requires a Senior level Consultant with CAR-T process development experience. This project position will likely be 10-20 hours/week initially, with potential increase in workload over the first few months. Tasks include:
- Review and possibly edit CMC documentation
- Evaluate various processing platforms
- Review tech transfer documentation
- liaise with with CMO when selected
- Support development work with internal client research team
Qualifications
- Qualified candidates will possess a Bachelor’s degree in related field along with 10 plus years related industry experience.
- Candidates must have excellent verbal communication and technical writing skills.
- Experience in executing protocols including systems such as Process Validation, computer controlled systems validation, utilities, manufacturing equipment such as computer controlled filling systems, formulation systems and basic knowledge of laboratory validation (not required but preferred).
- Familiarity with many aspects of validation is expected.
- Experience with temperature mapping.
- Proficient in Microsoft Word, Excel, Power Point and Project.
- Must be willing to travel regionally and/or nationally throughout the US.
Additional InformationWe celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***