- Lead and perform mass spectrometry characterization of biotherapeutics from discovery to marketed products. The candidate should be an expert and leader in characterizing antibodies, proteins, and peptides by mass spectrometry. This includes, but is not limited to, intact molecular weight analysis, subunit analysis, peptide mapping, modification identification, disulfide bonding analysis, glycan analysis, sequence variant analysis, host cell proteins, native MS, and other analytical methodologies using HPLC/UPLC ESI-ToF, ESI-Orbitrap, and MALDI-ToF instrumentation
- The candidate must have excellent team, organizational, writing, and presentation skills. This position will interact regularly with scientific staff in other Research & Development groups as well as Analytical Sciences, Process Development, Manufacturing, QA and QC, and CRO's. The ability to accurately and independently generate and review procedures, protocols, reports, and CMC section content for regulatory filings pertaining to protein characterization is a crucial requirement of this position. Candidate should have a focus on quality and completion of tasks right the first time.
- As a scientific leader, the candidate must be able to manage and lead projects independently, drive protein characterization strategies, improve quality and efficiency of workflows, develop new methods, stay current with industry and regulatory standards, representative on cross-functional teams, provide scientific guidance to team members, and train and oversee some day to day responsibilities of junior scientists.
- Leading and performing protein characterization (method development and analysis) by LC/MS.
- Oversee and train associates to perform method development and analysis by LC/MS.
- Lead and participate in cross-functional development teams representing the Protein Characterization group and lead scientific/technical problem-solving efforts with the group.
- Authoring and reviewing CMC sections for regulatory, technical reports, department-specific protocols and reports, and general operating procedures. Leading the development and authoring of new procedures and work practices.
- Lead and evaluate new instruments, technologies, methods, and techniques to enhance protein characterization.
- Manage the activities of external research laboratories.
- Deep understanding and extensive hands-on experience with protein characterization by LC/MS using multiple mass spectrometry instruments and platforms.
- Ability to lead problem solving activities and bring independent, scientific approaches to method development.
- A thorough understanding of regulatory and quality guidelines; and industry trends related to characterizing biotherapeutics.
- The individual must be able to give clear instructions, train, and oversee personal as required on practices within the laboratory. Planning, organizing, and communication skills required to plan, execute, track, and prioritize commitments of the laboratory.
- Excellent interpersonal skills are required, as is the strong ability to communicate effectively.
- The duties of this role are generally conducted in an lab environment. As is typical of a lab-based role, employees must be able, with or without an accommodation to: lift/carry 15/30 pounds unassisted/assisted; work comfortably in a controlled environment with and around biological, infectious, and hazardous materials; gown/degown PPE; use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
- PhD in Biochemistry, Chemistry or related discipline and a minimum of 5 years related experience.
- In-depth knowledge of additional non-MS methods and instrumentation for testing biotherapeutics.
- Experience with development, optimization, qualification, and validation biotherapeutic assays.
- Experience working with CRO's for developing assays and testing of samples.
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Scientist III, Analytical Development and Clinical QC - New Haven, United States - Alexion Pharmaceuticals, Inc.
Description
This is what you will do:
You will be responsible for:
You will need to have:
We would prefer for you to have:
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.
We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
