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Scientist II/Scientific Technical Leader New

17084d17505a

Apex Systems

Negotiable

Cambridge, United States

United States

Other

ASAP

04/05/2021

03/06/2021

Not specified

Permanent | Full Time

Scientist II, Analytical Development 1114624Job Scope & Purpose:Our exceptional Cambridge based client, focusing on the potential of genome editing for a variety of programs in rare diseases, is seeking a talented, highly-motivated Scientist II, Analytical Development to develop and optimize analytical methods for engineered cell medicines, perform technical transfer of assays, support Quality, and contribute to regulatory filings. This role on the Process and Analytical Development team contributes to efforts to develop safe and effective engineered cell medicines using CRISPR-based gene editing technologies.Primary Job Responsibilities:* Work collaboratively with Research to transfer assays into Analytical Development.* Independently perform assay development and optimization.* Collaborate with Process Development and Quality to generate data to support formulation studies, stability studies, and characterization of drug substance and/or drug product.* Perform analytical method technical transfer, including generating supportive documentation, training, and technical support to Quality Control or central testing laboratories, including providing technical support for assay qualification and validation efforts.* Compile and present data to program teams. Participate in program teams. Lead technical sub-teams.* Author and review test methods, technical reports, and supporting procedures.* Document all experimental work, supporting information, and data in an electronic lab notebook or test methods in a timely manner.* Manage and actively participate in, as required, the testing of reference standards, lead stability samples, forced stability samples, toxicology lots, engineering runs, and clinical manufacturing runs, as appropriate.* Provide guidance to research associates and cross-train personnel.* Author, review, and provide technical expertise on analytical methods during the preparation of CMC-related regulatory filings for engineered cell medicine programs.* Support Quality with required data, technical assessments, and expertise, including contributing to management reviews, change controls, CAPAs, deviations, stability plans, specifications, OOS results, comparability assessments, and assay validation.Primary Job Requirements:* PhD in a life science discipline such as Immunology, Cell Biology, Biological Sciences, Biotechnology, Molecular Biology or Master's in a life science discipline such as Immunology, Cell Biology, Biological Sciences, Biotechnology, Molecular Biology, or Biomedical Engineering with 8+ years, or Bachelor's with 12+ years of relevant analytical development, technical transfer, and quality control experience.* Experience with cell culture, flow cytometry, and cellular analytical methods. This includes biophysical, bioassay, and/or molecular assay methods.* Experience related to the development and/or technical transfer of CGMP test methods for biologics.* Knowledge of CRISPR/Cas9 gene editing technologies and molecular assays, including ddPCR.* Understanding of product development life cycle and stage gates from research to clinical development to commercial operations.* Knowledge of FDA, EMA and ICH regulations, industry standards and quality control principles for CGMP operations.* Attention to detail and the ability to work inpidually, within a multi-disciplinary team in a matrix environment, as well as with external partners and vendors.* Strong organizational skills with the ability to multi-task, problem-solve, prioritize assignments, and adjust priorities to meet goals in a fast-paced environment.* Strong verbal and written communication skills.* Strong leadership skills.Preferred Requirements:* Knowledge of CRISPR/Cas9 gene editing technologies and molecular assays, including ddPCR.* Understanding of product development life cycle and stage gates from research to clinical development to commercial operations.* Knowledge of FDA, EMA and ICH regulations, industry standards and quality control principles for CGMP operations.About Stratacuity:Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.PROVEN SCIENTIFIC PLACEMENTâ„¢Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.krees@stratacuity.comCode: TechOps#LI-KR1EEO EmployerApex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.



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