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Role Description

The experienced professional is responsible for drug substance process development and manufacturing support in the Technical Operation division. Key responsibilities include:

• Oversite and technical guidance for upstream and downstream process development activities executed at CDMOs for next generation processes.
• Technology transfer and development studies to enable process validation.
• Process support and trending analysis for clinical and commercial supply chain activities.
• Partnering with functional areas such as Analytical Development, Drug Product, Quality Assurance, Regulatory CMC, and Quality Control.
• Reporting to the VP, Drug Substance.

The ideal candidate will have prior experience leading late-stage drug substance process development efforts within a biotechnology company, along with technology transfer of such processes to manufacturing and execution of required studies to enable Process Performance Qualification (PPQ). The candidate should also have:

• Experience executing, authoring, and reviewing key process development and process characterization studies.
• Experience with CMC regulatory sections for health authorities.
• A strong understanding of biologics drug substance manufacturing, regulatory expectations, and guidance.
• Knowledge of statistical methods utilized for process development and manufacturing process control.
• Liquid formulation experience is a plus.

The individual in this role will be an important contributor to the development of late-stage drug substance manufacturing processes, collaborating within the Drug Substance team and with partners at CDMO and other contracted support teams.

Qualifications

• Bachelor's degree and 9+ years of experience OR:
• Master's degree and 7+ years of experience OR:
• PhD/JD and 5+ years of experience.
• Understands cGMP and GLP aspects of biopharmaceutical production.
• Experienced in process development, manufacture, and scale-up of mammalian or microbial processes, ideally in both upstream and downstream.
• Liquid formulation development expertise is a plus.
• Experience in establishment and qualification of small-scale models for manufacturing process characterization.
• Understanding of relevant protein related analytical techniques: LC, UV, CE, ELISA for product and impurity analysis.
• Excellent communication skills (both verbal and written) and interpersonal skills are required.
• Works on complex problems requiring evaluation of intangible variables, utilizing ingenuity and creativity.
• Presents results of work, interprets data, and draws conclusions regarding presented material.
• Maintains full working knowledge of current regulatory guidance and expectations for clinical and commercial biologics products.
• Demonstrates technical proficiency, collaboration with others, and independent thought in suggesting project design and strategy.
• Must think critically and creatively, work independently, and have strong organizational and planning skills.
• Demonstrates collaborative communication and problem-solving spirit.

Requirements

• Ability to travel up to 20%, both internationally and domestically.

Benefits

• Base compensation range: $152,700 to $267,300.
• Eligible for a company bonus based on individual and company performance.
• Long-term incentive compensation depending on the position's level or other company factors.
• Participation in employee benefit programs including medical, dental, and vision coverage.
• Life insurance and disability insurance.
• 401(k) savings plan and flexible spending accounts.
• Employee assistance program and tuition reimbursement program.
• Voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance, and auto/home insurance.
• Time off pursuant to sick time policy, flexible vacation policy, and parental leave policy.