Job Summary:

This position is responsible for the design, execution, and reporting of process characterization and process validation studies for programs entering late-stage development. The successful candidate will have a good understanding of the role of characterization and validation studies in process development, with excellent attention to detail and record keeping, and strong communication skills. The individual may also contribute to the development of novel processes or optimization of existing processes for programs in an earlier stage of development. The position necessitates a collaborative approach with other Development functional groups, Manufacturing, Validation, and Regulatory Affairs, towards the goal of transitioning products from development to commercialization.

Essential Functions:

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.

Education & Credentials

BS, MS, or PhD in the biological sciences or related field

Preferred Qualifications

Salary Range:
$75,000-$104,000

• Design process characterization and process validation studies and author protocols.
• Execute process characterization studies to establish process understanding and define critical process parameters.
• Support process validation activities by executing studies and interpreting results.
• Maintain accurate laboratory records and ensure activities are conducted in compliance with applicable quality and safety requirements.
• Generate, interpret, and communicate experimental results through technical reports, presentations, and development summaries for both internal teams and clients.
• Collaborate with analytical, upstream, formulation, and manufacturing teams to support integrated process development activities.
• Other duties as required
• BS, MS, or PhD in the biological sciences or related field
• BS with a minimum of 4 years of experience, MS with a minimum of 2 years of experience or PhD with no previous experience
• Minimum of 4 years of biotech industry experience
• Possess in-depth understanding of downstream unit operations
• Understanding of downstream process development and process transfer to manufacturing
• Experience operating purification equipment such as ÄKTA or equivalent
• Familiarity with small-scale model studies using Design of Experiments (DoE) approach
• Familiarity with process validation at both small and large-scale
• Excellent technical writing skills and oral communication skills
• High energy results-driven individual
• Willingness to be hands on
• Experience performing biologics analytical techniques (HPLC, Capillary Electrophoresis, ELISA)

Compensation and Benefits

We offer a comprehensive benefits package designed to support our employees' wellbeing, including:

• Competitive salary and performance-based incentives
• Comprehensive health coverage including medical, dental, and vision insurance
• Retirement savings plans with employer matching contributions
• Paid time off
• Professional development opportunities
• Employee wellness programs and resources
• Employee Assistance Program and Mental Health Resources