The Senior Manager, Downstream Process Development and Manufacturing drives downstream process development and technical transfer activities supporting all stages of development through commercial manufacturing at CMOs. Downstream process development includes chromatography capture steps, viral clearance strategies, polishing operations, and filtration/concentration/formulation steps.
- Develops strong interface with contract manufacturing organizations (CMOs)/contract research organizations (CROs) to optimize process operations and ensure they are scalable. Supports technology transfer to external CMO’s.
- Ensures viral clearance strategies and execution are in alignment with regulatory expectations
- Provides person-in-plant (PIP) support for critical manufacturing operations
- Responsible for the management and review of cGMP-compliant documentation (master batch records, etc.), as well as the post-manufacturing review and close-out of executed batch records
- Review CMO deviation/OOS investigations to ensure proper root cause determination and conclusions.
- In conjunction with QA and RA, ensure all CMOs and downstream processes are compliant with the applicable Corporate, Quality and Regulatory requirements and regulations
- Review appropriate sections of regulatory filings (IND, IMPD, BLA)
- Apply advanced technical writing skills to produce reports and documents; writes independently and evaluates the writing of others
- Formulate and recommend operational/ technical standard and practice documents for supporting continuous process improvements and product life-cycle management.
Education & Experience:
- Bachelor’s or Master’s degree in life sciences, chemical engineering, biochemical engineering or related field with six to eight years of relevant industry experience
- Experience with technical transfer and scale up to pilot or large scale cGMP manufacturing
- Direct experience in preparing and reviewing CMC documentation for regulatory filings and supporting inspections
Knowledge and Competencies:
- Proficient in biologic drug substance processes (particularly monoclonal antibodies); expert in downstream purification operations such as centrifugation, filtration, UF/DF, chromatography, viral inactivation and viral filtration at development and manufacturing scale.
- Working knowledge of analytical methods used to support biologics purification process development
- Experience with statistical design of experience (DoE) and Quality by Design (QbD) is preferred.
- Strong, open and transparent communication skills (verbal and written)
- Solid organizational and time management skills
- Project management skills and computer proficiency (JMP/ MATLAB, MS Project, Excel, Word, Power Point)
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to finger, handle, or feel. The employee is occasionally required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision and ability to adjust focus in order to read.
The work environment characteristics are representative of those an employee encounters while performing the essential functions of this job, typically in an open office environment. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The noise level in the work environment is usually moderate.
May be required to travel by plane or car 10% of the time (internationally and domestically).
This position requires working with biological and/or chemical hazards.
All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.