Manager, Analytical Development
The Manager of Analytical Development will lead a multitude of external Analytical development and Quality Control (QC) activities including, but not limited to: method development, establishment of specifications, product testing, stability support, product comparability, reference standard programs. This position will be supporting both pre-development and early to late stage biologics drug development programs including oversight of external contract testing performed by CRO’s and CMO’s for Drug Substances (DS) and Drug Products (DP).
- Manages in-process and release method development, establishment of specifications, review of QC data from release and stability samples, product comparability and reference standard programs in support for early to late-stage biologics drug development programs:
- Writes (as needed), reviews and approves protocols, analytical methods and reports for biologics Drug Substance (DS) and Drug Product (DP) at external CRO and CMO labs.
- Reviews technical data, and performs QC, trending and statistical analysis of data.
- Coordinates and provides oversight and review of QC data generated at CMOs.
- Leads technical data assessments for process monitoring and method monitoring.
- Drives testing compliance with adherence to test method, studies, validations, and to regulatory submissions.
- Supports Discovery and Protein Sciences group in analytical evaluation of new candidates entering CMC development.
- Evaluates and assesses modifications/updates/optimization of external analytical methods.
- Provides technical input on investigations for aberrant results, OOT, and OOS results and review of CMO reports for investigations.
- Provides strategy for QC-related changes and initiate/review/approve QC-related change controls.
- Supports method qualification, validation, and method enhancement for external products. Reviews related protocols and reports.
- Assists in external laboratory audits and inspections as needed.
- Supports Analytical/Product Development in aspects of technology transfer, process scale-up, and process validation activities at CMOs.
Knowledge and Competencies
- Ability to perform statistical analysis of data using JMP.
- Demonstrated ability to manage reference standard programs.
- Expert writing and reviewing regulatory filings skills with a strong understanding of regulatory requirements.
- Thorough understanding of GMPs, GDPs, ICH guidelines, and regulatory guidelines.
- Previous working experience in cGMP biologics analytical lab is desired.
- May be required to design and execute experiments in lab and write reports 20% of the time.
- Proven ability to work closely with internal departments, partners and CMOs including senior management on significant matters concerning projects and commitments.
- Effective problem solving and negotiation skills to meet business objectives in a highly dynamic global business environment.
- Software Knowledge: Windows, MS Office (Outlook, Word, Excel), Adobe, JMP.
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 20% of the time.
- This position requires working with biological and/or chemical hazards.
Education & Experience
- Bachelor’s degree in a scientific discipline.
- Five plus years of analytical chemistry for biologics and QC experience in the biopharmaceutical industry.
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.