Mantell Associates is currently partnered with one of the most exciting CDMOs bringing excellence in manufacturing & quality to the rapidly growing Cell and Gene Therapy market. My client is a dedicated commercial biologics CDMO focused on the development and cGMP manufacture of biopharmaceuticals derived from mammalian cell culture. My client is currently constructing a world-class purpose-build 53,000 sq. ft. viral vector development and cGMP manufacturing facility in California and is on the hunt for Senior Scientists. This person will play a critical role in setting up a new Business Unit and building it out from scratch.
The Senior Scientist will be responsible for complex programs related to all aspects of viral vector purification, generating bulk drug substance and drug product. He/she will support the group regarding downstream activities/initiatives.
Essential Functions: (Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.)
Undertakes complex and multi-faceted client and innovation programs.
Applies established platform approaches and utilize problem-solving skills to rapidly solve day to day experimental challenges. Provides support to the team regarding downstream activities.
Performs experiments at the bench and pilot scales, spanning the end- to end downstream drug substance/ drug product processes
Applies fundamental scientific and engineering principles to purification processes in order to support process development and process characterization, evaluate process improvements and resolve potential processing issues
Communicates work through oral presentations and written documentation including technical reports and GMP documents to support regulatory filings
Participates in cross-functional teams and interact with representatives from Process Development, Project Management, Manufacturing, and Quality to arrive at and implement viable /practical solutions to support clinical/commercial manufacturing
Provides scientific technical support for technology transfer of processes to manufacturing
Utilizes out-of-the-box thinking to contribute to technology development
Proficient with design of experiments and statistical analysis of data
Primary project contact with a client and must be articulate around the science and problem solving
Supervises a team of junior scientists and research associates
Manage timelines and coordinate resources with function heads to ensure project deliverables are achieved
Required Education and Experience:
PhD in Molecular Biology, biochemistry, chemical/biochemical engineering or related disciplines with a minimum 5 years of in-depth technical experience in purification process development for viral vectors or and large molecules from mammalian and insect cells. Knowledge and experiences in purification process engineering and process scale-up/scale-down design is essential. Leadership experience as a successful leader in a strategic multifunctional environment. Strong business acumen and critical thinking.
Experience in process characterization and validation. Hands-on experiences with technology transfer of manufacturing process. Knowledge of CGMP's, regulatory guidelines, validation practices, and other relevant regulatory requirements. Excellent interpersonal communication and presentation skills.
Directs activities of functional areas through manager, supervisor and scientist level employees.
Position Type/Expected Hours of Work:
This role is a full-time exempt position. Days of work are Monday through Friday unless otherwise stated by Supervisor or needed due to projects. Must be available to work holidays, weekends, or extended hours when needed.
Occasional travel by land and/or air may be required to attend seminars or conferences or client meetings.
Medical, Dental, Vision, Life, and Long-Term Disability Insurance
Employee Stock Purchase Plan (ESPP)
15 Days PTO, 8 Designated Holidays, and 4 Floating Holidays per year
Tuition Reimbursement Program
- Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm.
- For more information on this role, please contact Dhiren Patel on +44 (0)20 3778 0990 or email@example.com