Consolidated Precision Products Corp.

Principal Scientist, Late Stage Upstream Process Development (San Francisco, CA)

Consolidated Precision Products Corp. • $150K — $180K *
San Francisco, CA 94112In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • PhD in biology, biochemistry, chemical engineering or related field with 7+ years of experience, or BS/MS with 12+ years in biotech/biopharma.
  • In-depth knowledge of CHO-based fed-batch processes and scale-up/scale-down principles.
  • Strong understanding of various bioreactor types and tech transfer methodologies.
  • Proven experience in late-stage upstream process development and authoring BLAs.
  • Strong compliance knowledge with regulatory expectations for process validation.
  • Exceptional communication and leadership abilities for cross-functional teamwork.
  • Innovative problem-solving skills with a proactive approach.

Responsibilities

  • Lead the scale-up and tech transfer of processes to manufacturing while ensuring compliance with regulations.
  • Act as the technical lead for large molecule commercial manufacturing support.
  • Create and review CMC documentation including process validation and regulatory submissions.
  • Develop and implement strategies for process performance qualification and verification.
  • Work collaboratively across multiple departments, including Manufacturing, QA, and Regulatory.
  • Represent upstream processes in regulatory and technical meetings with external partners.
  • Provide expert support for process-related issues and assessments.

Benefits

  • Opportunities for professional development and continuous learning.
  • Collaborative and innovative work environment.
  • Participation in cutting-edge biotech projects.
  • Possible involvement in interactions with high-profile regulatory agencies.
  • Flexible work arrangements supportive of work-life balance.
Full Job Description
Client is seeking an experienced and driven scientist/engineer to lead late-stage upstream cell culture process development activities for clinical and commercial-stage large molecule programs. This individual will serve as the upstream lead for scale-up and tech transfer to manufacturing sites, establishing process validation (PV) strategy and PPQ/post-approval process support.

Key Accountabilities/ Core Job Responsibilities
  • Lead scale-up and tech transfer of the upstream process to manufacturing sites, ensuring alignment with control strategy and regulatory filings.
  • Serve as the technical lead, responsible for upstream process activities for a late-stage large molecule programs including commercial manufacturing support
  • Author and review relevant CMC documentation including PV protocols/reports and regulatory sections (e.g., BLA, IND amendments).
  • Develop and execute strategies for process performance qualification (PPQ) and continued process verification (CPV).
  • Collaborate cross-functionally with MSAT, Downstream, Analytical Development, CMC management, Manufacturing Operations, QA, QC, Regulatory, and Contract Manufacturers
  • Represent upstream function in regulatory strategy, technical meetings, and CDMO interactions.
  • Provide technical support for upstream process-related investigations, product impact assessments, change control assessments, CAPA assessments etc.
Qualifications/Skills
  • PhD in biology, biochemistry, chemical engineering or related scientific discipline with minimum 7 years of cell culture process development experience in the biotech/biopharma industry; or BS/MS with 12+ years of experience.
  • In-depth understanding of CHO-based fed-batch processes, scale-up/scale-down principles, and statistical tools.
  • Thorough understanding of cell culture bioreactors including microbioreactors, bench-scale and pilot-scale bioreactors, and scaleup/tech transfer activities
  • Demonstrated experience with late-stage upstream process development, PPQ strategy, tech transfer and BLA authoring
  • Strong knowledge of regulatory expectations for process validation and control strategies.
  • Excellent communication, leadership, and cross-functional collaboration skills.
  • Demonstrated ability for taking initiative, creativity, and innovation in problem solving
  • Experience working with novel large molecule formats such as bispecific antibodies and Fusion proteins/enzymes is a plus
  • Demonstrated technical writing, critical thinking, scientific problem-solving and communication skills

About Consolidated Precision Products Corp.

Consolidated Precision Products Corp. is a manufacturer of complex metal components and products for the aerospace and defense industries. The company was founded in 1991 and is headquartered in Carrollton, Texas. Consolidated Precision Products Corp. operates a network of manufacturing facilities across the United States, as well as in Mexico and Europe. The company's products include castings, forgings, and machined components, as well as assemblies and sub-assemblies. Consolidated Precision Products Corp. is committed to providing high-quality products and services to its customers.
Learn more about Consolidated Precision Products Corp.
Size
3,000 employees
Industry
Aerospace & Defense
* Ladders Estimates

Similar Jobs

Ad banner background

Get Ready For Your
Next Interview

More Jobs at Consolidated Precision Products Corp.

More Pharmaceuticals & Biotech Jobs

Find similar Principal Scientist, Late Stage Upstream Process Development (San Francisco, CA) jobs:

NationwideSan Francisco, CA