Job Summary - a concise overview of the job
The successful candidate will execute and oversee the execution of Collagenase Clostridium Histolytium in-process and release test methods for the Bioprocess Technical Operations group. Additionally, the scientist wil
optimize & troubleshoot existing assays, develop new assays, perform analytical assays in support of process & product development, and lead or conduct analytical method transfer & validation. In addition, the candidate will act as a subject matter expert for analytical technologies at the Horsham site. All of the above responsibilities require independent execution with general guidance from BTO management.
All incumbents are responsible for following applicable Division & Company policies and procedures.
Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.
This role will work cross functionally with Bioprocess Technical Operations scientists, Quality Control, Manufacturing, R&D, Quality Assurance, Regulatory Affairs, and other organizations across the company to execute assigned objectives. The position may also have supervisory responsibility in either a short duration capacity or longer duration as needed.
Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time
% of Time
Assay Development & Optimization
Develop & optimize enzymatic assays, immunoassays, electrophoresis, chromatography (CE, RP-HPLC, SE-HPLC, etc.), and other methods.
Author protocols, reports, SOPs/test methods as needed to support the development and optimization of assays.
Provide training to QC and other relevant personnel during assay development/optimization and transfer.
Coach and provide technical guidance to junior scientists in method development and validation as well as troubleshooting of method.
CMC / R&D
Author and review CMC documents and correspondence.
Partner with R&D colleagues to design and execute studies in support of clinical and pre-clinical development.
Manange subordinate staff, including weekly workload assignments and projet/study management of the assigned work.
Mentor junior staff, both direct report(s) and team members
Education & Experience
Minimal acceptable level of education, work experience and certifications required for the job
BS degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, Cell Biology, or related discipline + min. 12 years' direct experience;
MS degree in the above disciplines + min. 12 years' relevant experience OR
PhD in the above disciplines + min. 10 years' relevant experience is preferred.
Extensive hands-on experience in electrophoresis, chromatography, enzymatic assays and immunoassays for therapeutic proteins.
Experience working with or supporting late stage clinical and commercial products preferred
Previous people management preferred.
Proficiency in a body of information required for the job
e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
Extensive knowledge of the biologic process and analytical development life cycle, cGMP, cGLP and FDA/ICH guidelines.
Subject matter expert for analytical technologies.
Extensive knowledge of analytical chemistry and concepts in developing and validating methods to meet correct pharmaceutical standards.
Strong knowledge of ANDA product development process.
Extensive knowledge of FDA, ICH and USP guidance and regulations.
Superior knowledge of major analytical techniques such as HPLC/UPLC, GC, and FTIR etc.
Additional expertise in analytical techniques such as residual DNA and residual host cell protein analyses would be beneficial.
Often referred to as "competencies", leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.
Design and execution of analytical testing in an independent manner with minimal guidance from BTO management
Strong method development skills, including optimization, qualification/validation, troubleshooting, and implementation of assays.
Ability to exhibit open and constructive communication style based on the need of the receiver(s) and by using the appropriate communication method.
Strong data and statistical analysis skills required; experience using statistical analysis software preferred.
Able to plan & execute complex technical activities and projects in a dynamic, team based environment with the ability to work independently when needed; troubleshoot and develop/validate assays with little to no supervision.
Strong organizational and time management skills.
Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.
Standing for moderate periods of time.
Wearing lab coat, gloves, and other personal protective equipment required for working in the laboratory/biologic cleanroom environment as required, to carry out assigned responsibilities.
Travel as needed to other internal company sites, third party & partner sites, but not expected to exceed 5-10% of time on an annual basis.