The Carlsbad Gene Therapy Viral Vector Manufacturing is a contract manufacturing site that produces drug substances and drug products for gene therapy and oncology applications. We are seeking a MSAT Senior Scientist who will be responsible for supporting client-facing projects, process transfer from Development to cGMP Manufacturing as a member of the Tech Transfer team within MSAT. As part of a dynamic Contract Manufacturing Organization, the successful candidate will work cross-functionally with the Manufacturing, Process Development, Project Management, and Quality teams to ensure successful and timely process transfer and scale-up for client-facing projects.
location: Carlsbad, California
job type: Contract
salary: $65 - 72 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Generate and update cGMP documentation (batch records, item specifications, SOPs, bills of materials, production summaries, etc)
- Collaborate cross-functionally with both internal and external stakeholders to implement changes which enable continuous improvement, scale-up, and sustaining existing cGMP manufacturing processes.
- Lead the execution of process risk assessments, qualification protocols and reports, and other operational activities that increase safety, reduce operation costs, and maintain cGMP compliance.
- Drive change controls and related efforts to update manufacturing documentation including batch records, item specifications, forms, SOPs, and bills of material for existing processes.
- Own the transfer of internal and client-facing processes from development into manufacturing.
- Engage internal teams to resolve Corrective Action/Preventive Action (CAPA) relating to existing cGMP manufacturing and documentation in a timely manner.
- Proactively identify process gaps and/or inefficiencies, perform root cause analysis, and propose solutions.
- Provide technical support during client and regulatory site audits as needed.
- Support and execute Engineering / Pilot runs for viral production, purification, formulation and filling and train manufacturing staff as needed
- Technical resource for all staff and other departments
- Influence decisions in the evaluation of new techniques and procedures for systems, products or technologies
- Demonstrate mastery in data analysis and interpretation
qualifications:
Required Qualifications:
- Bachelor's or Master's degree in Biochemistry, Chemistry, Chemical Engineering, or other Life Science related field. Years of experience and skill set may substitute for education.
- 12+ years (BS), 8+ years (MS), or 5+ years Ph.D process development, engineering, and manufacturing experience required. CDMO experience is a plus.
- 10+ years in drug product fill / finish and formulation. Viral vector drug product is a plus.
- Experience with cGMP manufacturing and Quality Systems within a regulated environment.
- Large scale experience with automated filler / isolator machines
- Expert level in aseptic processing
- Large scale experience with molecule biopharmaceutical production, viral vector production, mammalian cell culture processes (adherent and suspension), and single use systems.
- Expert level in fill/finish and formulation of drug product
- Expert-level skill set in reading, understanding, and improving manufacturing-facing and/or client-facing process documentation.
- Ability to identify, propose, and lead broad/cross-functional solutions to improve the scalability and efficiency of both manufacturing and documentation procedures.
- Expert-level skill set regarding cGMP document control systems and general procedures.
- Ability to work independently and as part of a team on multiple projects simultaneously.
- Excellent attention to detail, with superior documentation and organization skills.
- Excellent computer, verbal, and written communication skills, including strong technical writing ability.
skills: Biology, Chemistry, Mammalian Cell Culture, Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), Quality Assurance (QA), Quality Control (QC), Quality Management Systems (QMS)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
Qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
