Celgene Associate Director, Analytical R&D in Summit, New Jersey
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
The successful candidate will be highly motivated 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 Associate Director position will be responsible for managing the development and validation of analytical methodology for the characterization of our products and processes, the creation of fundamental product and process understanding, and the advancement of innovative approaches to drug development. Support for drug candidates across all stages of development and, as needed, within our commercial product portfolio will be required.
The Associate Director should work with minimal supervision to support laboratory based de novo analytical methods development, chemical characterization studies and chemical stability characterization evaluations. Where required, leadership oversight will include activities that will be performed in accordance with cGLP/cGMP regulations, established business processes and protocols, and applicable standard operating procedures.
The Associate Director will have organizational, interdepartmental and interdivisional responsibilities with regards to leading workgroups, cross-functional teams, strategy development/implementation/execution, and cultural initiatives.
Support drug substance process development including characterization of starting materials, intermediates and final API.
Support drug product formulation and process development including characterization of the process and finished product.
Develop, optimize and validate analytical methods.
Support drug substance and drug product impurity characterization and identification.
Generate laboratory clinical release and stability data.
Qualify/transfer analytical methodology to quality control and contract laboratories.
Where appropriate, oversee and manage the relationship with external partners.
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.
Serve on company due diligence teams assessing external product development opportunities.
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.
Completed BS in Chemistry (or relevant discipline) and minimum of 15+ years of pharmaceutical laboratory experience required; or
Completed MS in Chemistry (or relevant discipline) and minimum of 12+ years of pharmaceutical laboratory experience required; or
Completed Ph.D. in Chemistry (or relevant discipline) and minimum of 10+ years of pharmaceutical laboratory experience required: or
Completed Ph.D. in Chemistry (or relevant discipline) with post-doctoral academic research experience and minimum of 8+ years of pharmaceutical laboratory experience
Academic background in Analytical Chemistry or an allied chemistry discipline (e.g. Physical, Organic) with demonstrated analytical capabilities.
Comprehensive knowledge of chemistry with extensive expertise in measurement science.
A demonstrated record of scientific accomplishment, laboratory experimentation, publication and presentation.
Extensive laboratory experience with and an in-depth knowledge of conventional laboratory characterization techniques such as HPLC, GC, UV, IR, mass spectrometry, and NMR is a must.
Fluency in more than one of the following areas is expected: synthetic chemistry, drug substance processing, formulation development, pharmaceutical processing or pharmaceutical sciences.
Strong problem-solving and troubleshooting skills.
Strong capabilities in experimental design and execution.
A demonstrated record of leading a high performing technical organization.
Ability to work and lead independently.
Ability to provide scientific guidance, leadership and training to others within the department.
Ability to directly supervise and manage others.
An absolute 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.
Working knowledge of cGLP/cGMP and applicable FDA, EMA and ICH guidances.
Familiarity with the USP and other compendia.
Skills/Knowledge in one or more of the following areas are a plus:
Advanced skills in statistics and statistical analysis of process capability.
Advanced skills in DOE, Lean and/or Six Sigma.
Knowledge of dissolution method development and testing, biopharmaceutical classification system, and IVIVC / IVIVR.
Modern laboratory automation.
Quality by Design
Advanced skills in PAT and chemometrics.
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.
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.
Associate Director, Analytical R&D
Location: Summit, NJ, US
Job ID: 17001618