Senior Director: Head of Upstream Process Development

Job Description

Job Description

Job Title: Senior Scientist/Engineer - Process Development & Upstream Manufacturing

Location: Boston, Massachusetts
Department: Bio process Development / Manufacturing Sciences
Reports To: Director of Process Development or Head of Manufacturing

Position Summary:

We are seeking a highly motivated and experienced Senior Scientist or Engineer to lead upstream process development activities for biologics manufacturing. This role will focus on the design, optimization, and scale-up of cell culture processes for therapeutic proteins, monoclonal antibodies, or other biologics. The ideal candidate will bring deep technical expertise in upstream bio processing, strong project leadership skills, and a collaborative mindset to drive innovation and operational excellence.

Key Responsibilities:

Process Development

• Design and execute experiments to optimize upstream processes including media development, feeding strategies, and bio reactor operations.
• Develop scalable processes for mammalian or microbial cell culture, ensuring robustness and reproducibility.
• Evaluate and implement new technologies to improve yield, productivity, and product quality.
• Author technical protocols, development reports, and regulatory documentation (e.g., IND, BLA).

Scale-Up & Tech Transfer

• Lead scale-up activities from bench to pilot and GMP manufacturing scales.
• Collaborate with Manufacturing, Quality, and Regulatory teams to ensure seamless tech transfer and process implementation.
• Support troubleshooting and root cause analysis during manufacturing campaigns.

Cross-Functional Collaboration

• Work closely with downstream, analytical, and formulation teams to ensure end-to-end process integration.
• Participate in CMC strategy development and contribute to project timelines and risk assessments.
• Interface with external CDMOs and technology providers as needed.

Data Analysis & Documentation

• Analyze complex data sets using statistical tools and modeling software.
• Maintain detailed records of experimental work in electronic lab notebooks (ELNs).
• Present findings to internal stakeholders and external partners.

Qualifications:

• Ph.D. in Chemical Engineering, Biochemistry, Biotechnology, or related field with 5+ years of industry experience; or M.S. with 8+ years.
• Proven track record in upstream process development for biologics.
• Hands-on experience with bio reactors (ambr, bench-scale, pilot-scale), cell culture systems, and process analytics.
• Familiarity with QbD principles, DoE, and regulatory expectations for biologics manufacturing.
• Excellent communication, leadership, and project management skills.

Preferred Skills:

• Experience with microbial fermentation or continuous processing.
• Knowledge of PAT tools and automation systems.
• Prior involvement in IND/BLA submissions or regulatory inspections.
• Experience working in a GMP environment or with CDMOs.

Why Join Us?

• Be part of a cutting-edge team advancing next-generation biologics.
• Work in a collaborative, innovation-driven environment.
• Competitive compensation, benefits, and career growth opportunities.

Company DescriptionA top 10 pharmaceutical company with an immense amount of growth after releasing their at home COVID diagnostic tests is looking to bring on 200+ Quality Individuals through a massive hiring campaign. In their search for Quality Specialists, the organization is looking for individuals who will be responsible for reviewing and actioning customer complaints, as well as investigation into said complaints.
Job Responsibilities:
•\tConducting Post Market Activities and Post Market Surveillance
•\tManaging Customer and Product Complaint Investigation programs
Education and Experience:
•\t1 YR. of experience in a technical role in the medical device/pharma/biotech industry
•\tBachelor's degree
•\tComputer proficiency

Company Description

A top 10 pharmaceutical company with an immense amount of growth after releasing their at home COVID diagnostic tests is looking to bring on 200+ Quality Individuals through a massive hiring campaign. In their search for Quality Specialists, the organization is looking for individuals who will be responsible for reviewing and actioning customer complaints, as well as investigation into said complaints.\r\nJob Responsibilities:\r\n•\tConducting Post Market Activities and Post Market Surveillance\r\n•\tManaging Customer and Product Complaint Investigation programs\r\nEducation and Experience:\r\n•\t1 YR. of experience in a technical role in the medical device/pharma/biotech industry\r\n•\tBachelor's degree\r\n•\tComputer proficiency