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 Senior Scientist position will be responsible for 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 manufacture.
Support for drug candidates across late stages of development and within our commercial product portfolio.
The Senior Scientist should work independently to carry out laboratory based analytical methods development and chemical stability evaluations as required.
Activities will be performed in accordance with cGLP / cGMP regulations, established business processes and protocols, and applicable standard operating procedures.
Support drug product manufacture and process development.
Optimize, remediate and validate analytical methods.
Support drug substance and drug product impurity characterization and identification as required
Qualify / transfer analytical methodology internally and to contract laboratories.
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.
Review analytical data for completeness and correctness.
Complies with Environmental Health and Safety 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.
Contributes to the ownership and advancement of lab instrumentation, work processes, and procedures.
Skills / Knowledge in the following areas are required :
BS / MS / PhD in Chemistry (or relevant discipline) with required years of experience
Fluency in synthetic chemistry, drug substance processing, formulation development, pharmaceutical processing and / or pharmaceutical sciences.
Mastery of chemistry(or associated discipline) with extensive expertise in measurement science.
Experienced in the development and performance of analytical tests for a variety of drug substances and products (including solid oral dosage forms and injectables).
Knowledge of dissolution method development and testing, biopharmaceutical classification system, and IVIVC / IVIVR.
Strong statistical knowledge and capabilities.
Understands drug development, CMC dossier for regulatory submissions as an author / reviewer.
Advanced skills in DOE, Lean and / or Six Sigma.
Familiar with modern laboratory equipment and automation
Support drug substance process development including starting materials, intermediates and final API.
In depth knowledge of API synthesis
Expectations of the Senior Scientist include :
Strong verbal and written communication skills and interpersonal skills as a team member / leader in an environment where individual initiative, collaboration and accountability are valued.
A demonstrated record of scientific accomplishment, laboratory experimentation and presentation.
Direct impact on departmental performance. This impact is achieved through driving team efforts and being a member of cross-
functional project teams.
An expert related to cGLP / cGMP and applicable FDA, EMA and ICH guidances.
Mastery of USP and other compendia and how they guide drug development decisions.
Strong problem-solving and troubleshooting skills.
Strong capabilities in experimental design and execution.
Works independently and through others to accomplish goals.
Ability to provide scientific guidance, leadership, and training to others within the department.
May supervise others directly and is a scientific leader / mentor within department.
Work as part of a cross site team on deviations assisting MS&T as required.