We are seeking an Analytical Development Scientist/Senior Scientist, Bioassay to join our Analytical Development team as a subject matter expert with a focus in immunoassays and bioassays, and secondarily in physicochemical (analytical) assays. They will be a critical member of Analytical Development responsible for leading the development and qualification of potency/analytical methods for monoclonal and bispecific antibodies, especially establishing robust assays for evaluation of product potency throughout the various stages of development and product lifecycle.
Join our team to contribute to the development of new potency/analytical methodologies and optimize existing methods; to establish robust assays that can be used to characterize different novel therapeutic antibody drugs throughout the various stages of development and product lifecycle.
In this role, you will be responsible for timely development of potency/analytical methods supporting process and qualification of methods for Quality Control in compliance with Quality Systems, and supporting transfer to quality control and to external contract organizations where they will be used in cGMP product testing, as well as overseeing IND enabling characterization methods to understand the structure of our molecules and the processes we use to purify them. Methods to be developed may include those by HPLC (SEC, IEC, RP, HIC, etc.), CE-SDS (reduced and non), ELISA, cell based bioassay, PCR, FTIR, UV-Vis, colorimetric, and/or other techniques. The candidate will design and execute scientific studies and will collaborate extensively with cross functional staff and with representatives from contract manufacturing and testing organizations.Responsibilities
- Meet corporate objectives for the development and qualification/validation of assays implementing technologies such as ELISA and cell based assays (e.g. gene expression bioassay) to test and characterize proteins and related compounds.
- Support pharmaceutical products throughout their lifecycle, such as development samples from Upstream Process Development and Downstream Purification Development, Formulation Development, DS and DP Manufacturing.
- Provide scientific input and demonstrate critical thinking into experimental design and execution, including guidance to address QC deviations and assist in root cause investigations.
- Write technical development reports and give oral presentations of data at departmental or interdepartmental meetings.
- Write, review, and edit SOPs and Test Methods for new procedures and assays; review, edit and revise existing SOPs to reflect changes in procedures.
- Act as analytical subject matter expert and contribute to the authoring and review of regulatory CMC sections (IND, BLA/MAA).
- Maintain lab compliance by performing routine housekeeping, including support of analytical instrument maintenance, ordering and stocking of lab supplies, maintaining of reagents, sample management, and compliance to safety regulations.
Qualifications and Education Requirements
- Lead the development, qualification, and transfer of analytical methods to be used in cGMP QC testing.
- Understanding of ICH guidelines such as "Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products" and QbD principles described in Q8(R2) Pharmaceutical Development.
- Experience with technologies such as HPLC (SEC, IEC, RP, HIC, etc.), CE-SDS, and spectrophotometry to test and characterize proteins and related compounds (e.g., impurities, post-translational modifications).
- Coordinate with other functional groups to support upstream and downstream process development studies and have some understanding and experience with determining critical quality attributes of protein therapeutics.
- PhD with 4 years+ of experience, Masters with 6 years+ of experience, or Bachelor's degree in a Scientific field with at least 8 years of relevant experience in a development or GMP environment, especially with protein therapeutics.
- Immunoassay and cell-based assay (bioassay) development and validation.
- Skills in Biological/Biochemical/Chemical Sciences, Math and English.
- Teamwork and communication are key attributes needed for this position, as this role will be part of a small team. A collaborative attitude and a positive work ethic are key traits for success.
- Excellent observation and attention to detail and accuracy for record keeping and documentation.
- Knowledge of cGMPs.
- Excellent verbal and written communications skills.
- Ability to work independently, and as part of a team on assigned projects.
- Proficiency with Microsoft Word, Excel and PowerPoint software is required. Knowledge of statistics (i.e. Descriptive, ANOVA, DOE) is desirable.
- Experience in the design, development, and validation of analytical methods and product characterization for monoclonal antibody therapeutics is strongly preferred.
- Learning Agility: Capability to think through problems from a fresh point of view, curiosity and passion for ideas and solving puzzles, love of learning.
- Detail Orientation: Ability to organize and prioritize many different important tasks.
- High Execution: Demonstrates and fosters a winning mind set, a sense of urgency, optimism, and ownership, and a strong drive to achieve goals.
- Collaboration: Demonstrated ability to work cross-functionally, manage crises and align interests of multiple parties, aptitude for mastering operational specifics of multiple programs.
- Communication: Excellent written and oral communication skills, technical writing and presentation skills are essential.
- Flexibility - Ability to adapt to changes, assess priorities and remain focused on goals.