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Senior Scientist - Bioassay, Analytical Development

Posted on Apr 5, 2021 by Acceleron Pharma Inc.

Cambridge, MA 02138
Immediate Start
Annual Salary

In this role, you will develop bioassays for release and characterization in support of fusion protein therapeutics in the Acceleron portfolio. The Sr. Scientist will lead and conduct bioassay method development, phase-appropriate qualification, transfer methods internally from R&D to AD and from AD to internal QC labs or contract testing organizations. The Sr. Scientist will design and conduct laboratory experiments, author reports, mentor junior team members, and serve as the subject matter expert (SME) for bioassays on cross-functional teams. Additionally, you will work with the internal team to develop analytical strategies and guidelines for integrated early and late stage development activities in support of biologics commercialization. As a key member of the AD-QC team, you will collaborate effectively and transparently with team members and functional leaders in the areas of Analytical Development and Quality Control, Drug Substance Development, Drug Product Development, CMC Project Management, Quality Assurance, Regulatory Affairs, and Clinical and Commercial Manufacturing.

What will you be doing?

Lead and conduct the development, optimization, troubleshooting, and qualification/transfer of characterization, release and stability bioassays, applying a thorough understanding of the scientific background of the product's mechanism of action
Develop bioassay release and stability methods that are robust and suitable for transfer to QC laboratories, including supporting the establishing of assay standards, controls, critical reagents, and system suitability criteria
Support bioassay method development and characterization testing at external partner, CLO, CMOs by providing technical review of qualification protocols, reports, data analysis, and troubleshooting method-related issues
Author study protocols, development/qualification reports, test methods, relevant sections of regulatory submissions, and responses to agency questions
Work cross-functionally with QC, R&D, Process and Formulation development to meet the program deliverables of the CMC Analytical organization, serving as SME for Bioassays and representing AD, as appropriate on cross-functional teams
Develop analytical plans to support clinical product development, product life-cycle management and associated regulatory submissions. This includes developing and implementing scientifically justifiable strategies and release/stability criteria for various scenarios including accelerated product development
Support all CMC filing activities for various pre-INDs, INDs, IMPDs, CTAs and BLAs and track analytical development/QC commitments
Actively participate in CMC regulatory writing activities for analytical development function, assist in review of regulatory filings in INDs/IMPDs, CTAs and BLAs and to ensure that CMC related changes are reported to competent authorities in accordance with regulatory requirements
Lead tech transfer of methods to QC testing facility and to CRO/CMO's. Manage and oversee analytical activities performed at CROs/CDMOs associated with method development and characterization for drug substance, drug product and reference standards
Develop and establish the strategies for product characterization with a focus on CQA assessment, comparability and lead characterization activities
Author, review and/or approve key documents such as: comparability protocols and reports, and relevant sections of regulatory filings (IND, IMPD, BLA, etc.)
Assure all laboratory documentation and other regulatory compliance systems are maintained according to corporate standards
Establish and implement processes to enable effective collaboration with CRO/CDMO business partners to ensure efficiency and high quality of results

Qualifications and Job Requirements:

Ph. D. in chemistry, biology, biochemistry, or biochemical/bioprocess engineering or related technical discipline with a minimum of 5+ years of biopharmaceutical analytical experience with recombinant biologic molecules or Masters in a similar discipline with 10+ years of the previously mentioned experience
Technical expertise in bioassay methods for release and characterization of antibodies and proteins including cell-based potency, ELISA binding, and effector function assays
Experience in developing methods for transfer to QC
Independently designs, conducts or oversees, interprets and presents results of complex bioassay method development studies; knowledge of applying QbD approaches to method development is a plus
Expertise in PLA, statistical data analysis and developing criteria for results reporting
Applied knowledge of ICH guidelines and phase-appropriate best practices for method development and qualification activities
Strong technical writing skills and experience authoring development reports and test methods
Experience in the biopharmaceutical industry with relevant experience in late stage product and process characterization for therapeutic proteins/mAbs
Significant experience with methods used for biopharmaceutical characterization as well as a thorough knowledge of structure-function relationship of therapeutic proteins
Demonstrated experience and knowledge in tech transfer of methods and life cycle management
Theoretical and hands-on knowledge and experience with methods used for biopharmaceutical characterization including HPLC based separation methods, peptide mapping, mass spectrometry, electrophoresis and other physicochemical technologies are desirable
Strong communication skills: ability to communicate (verbally and in writing) technical and non-technical information clearly to a diverse audience
Proven ability to work with at a high level of integrity, accuracy, and attention to detail
Ability to make thoughtful, integrated, timely and meaningful recommendations and/or decisions and take corresponding actions
Willingness to work collaboratively by incorporating diverse perspectives and appropriately managing relationships in order to strengthen decision-making

Reference: 1152695122

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