Job ID: 13500
Location: Summit, NJ
Full/Part Time: Full-Time
Department: Analytical Research & Dev - 3202
Celgene Corporation is committed to delivering innovative therapies designed to improve the lives of patients worldwide. We are a global biopharmaceutical company with operations in more than 70 countries that is helping to turn incurable cancers into chronic, manageable conditions. We are seeking talented professionals as we continue to grow and advance our efforts in oncology, hematology and immune and inflammatory disease. If you would like to join a company where you can make a difference, please consider the Celgene family.
BS in Analytical Chemistry, Biochemistry (or relevant discipline) and minimum of 12+ years of pharmaceutical laboratory experience required; or
MS in Analytical Chemistry, Biochemistry (or relevant discipline) and minimum of 10+ years of pharmaceutical laboratory experience required; or
Ph.D. in Analytical Chemistry, Biochemistry (or relevant discipline) and minimum of 8 years of pharmaceutical laboratory experience required: or
Ph.D. in Analytical Chemistry, Biochemistry (or relevant discipline) with post-doctoral academic research experience and minimum of 5 years of pharmaceutical laboratory experience
The successful candidate will be a highly motivated individual ready to work within a science-focused, collaborative, multidisciplinary drug substance and drug product development environment to achieve the company’s aggressive drug development targets.
Responsibilities will include, but are not limited to, the following:
The Principal Scientist position will have demonstrated experience evaluating and managing contract research organizations (CROs) to support therapeutic protein methods development/validation, characterization, lot release and stability testing. The successful candidate will also be responsible for knowledge development to facilitate fundamental product and process understanding, and the advancement of innovative approaches to the support of drug development. Support for drug candidates across all stages of development and, as needed, within our commercial product portfolio will be required.
The Principal Scientist should work with minimal supervision to lead/direct/manage analytical methods development, protein characterization studies and stability evaluations at CRO’s. Where required, activities will be performed in accordance with cGLP/cGMP regulations, established business processes and protocols, and applicable standard operating procedures.
The Principal Scientist will have organizational and interdepartmental responsibilities with regards to leading workgroups, cross-functional teams, strategy development/implementation/execution, and cultural initiatives.
- Manage the development, optimization and validation of analytical methods.
- Design experiments for the characterization of protein therapeutics.
- Design and lead the successful execution of experiments for comparability assessments.
- Oversee the generation of laboratory clinical release and stability data from CRO’s.
- Design experiments for the qualification/validation of analytical methods and their transfer to quality control and contract laboratories.
- Support therapeutic protein API process development and validation.
- Support therapeutic protein drug product formulation, evaluation of prototypes, process development and validation.
- Provide leadership and supervision to scientific staff.
- Develop, coach and mentor others.
- Serve on and lead departmental, interdepartmental and project teams.
- Report and discuss analytical results and conclusions both orally and in writing.
- Write formal reports for inclusion in regulatory filings and support the generation of appropriate responses to questions from regulatory authorities.
- Represent the company in discussions with regulatory authorities.
- Review analytical data for completeness and correctness.
- Adhere to all relevant compliance requirements.
- Ensure that all facilities, equipment and personnel are and remain in compliance with cGLP / cGMP, FDA and EMA requirements, appropriate SOPs and corporate policies.
Skills/Knowledge in one or more of the following areas are a plus:
- Academic background in Analytical Chemistry, Biochemistry or related discipline (e.g. Molecular Biology, Immunology) with demonstrated analytical capabilities.
- Comprehensive knowledge of protein analytics and characterization.
- A demonstrated record of scientific accomplishment, laboratory experimentation, publication and presentation.
- Extensive laboratory experience with and an in-depth knowledge of analytical methods and biophysical characterization techniques such as HPLC (RP, SEC, IEC), CE, MS, AUC, CD, DSC, Peptide Mapping, Peptide Sequencing, Oligo/Monosaccharide Analysis and Spectroscopy.
- Extensive laboratory experience with and an in-depth knowledge of bioanalytical techniques such as SDS-PAGE, DIGE, Western Blot, CE-SDS, ELISA, qPCR, Cell-based bioassays, BIAcore, cIEF, etc.
- Demonstrated experience with therapeutic protein characterization for registrational filings (BLA/MAA).
- Strong problem-solving and troubleshooting skills.
- Strong capabilities in experimental design and execution and data interpretation.
- Ability to work independently.
- Ability to provide scientific guidance, leadership and training to others within/outside the department.
- Ability to manage others and a commitment to and demonstrated proficiency in employee development.
- Strong verbal and written communication skills.
- Strong interpersonal skills and the ability and interest to serve as a team member/leader in an environment where individual initiative, collaboration and accountability are valued.
- In-depth knowledge of cGLP / cGMP, FDA, EMA and ICH guidances and industry standards for therapeutic protein development, analytics and characterization.
- Familiarity with the USP and other compendia.
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
- Advanced skills in statistics and statistical analysis of process capability.
- Advanced skills in DOE, Lean and/or Six Sigma.
- Modern laboratory automation.
- Quality by Design
Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.
Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Celgene support of a potential employee’s temporary visa application be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the employee and Celgene.
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