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Development Scientist
100 College Street New Haven, CT 06510 US
Job Description
- Perform mass spectrometry characterization of biotherapeutics from discovery to marketed products. The candidate should have a history characterizing antibodies, proteins, or 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, and other analytical methodologies using HPLC/UPLC ESI-ToF, ESI-Orbitrap, or MALDI-ToF instrumentation.
- The candidate must have excellent team, organizational, writing, and presentation skills. In addition, this position is expected to interact regularly with scientific staff in other Research & Development groups as well as Analytical Sciences, Process Development, Manufacturing, Quality Assurance and Quality Control groups. The ability to accurately and independently generate procedures, protocols, reports, and CMC section content for regulatory filings pertaining to protein characterization is a crucial requirement of this position.
- The candidate must be able to manage projects independently. Additional responsibilities may include oversee manufacturability of new research molecules, representative on cross-functional analytical teams, and training and overseeing 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.
- Participate in cross-functional development teams representing the Protein Characterization group and lead scientific/technical problem-solving efforts with the group.
- Authoring 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.
- Perform innovative technology evaluation and independently developing protein characterization strategies.
- Manage the activities of external research laboratories.
- Understanding and firsthand experience with protein characterization by LC/MS using mass spectrometry instruments and data analysis software.
- Ability to participate in problem solving activities and bring independent, scientific approaches to method development.
- An understanding of GLP and quality guidelines; and ability to contribute to process improvements.
- Planning and organizing skills are required to plan, execute, and track commitments of the laboratory and to adjust to changing priorities.
- An understanding of the “big picture” for projects and tasks involved, and ability to prioritize work accordingly.
- The duties of this role are 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 1-3 years related experience.
- The individual must be able to give clear instructions, train, and oversee personal as required on practices within the laboratory.
- 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.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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