Scientist II, Analytical Development

Employer
Celgene
Location
Summit, NJ, US
Posted
Aug 03, 2018
Ref
1802620
Required Education
Doctorate/PHD/MD
Position Type
Full time
Other Locations:US- NJ- Summit West

Description

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.

Scientist II, Analytical Dev - Solid State / Crystal Form Scientist
Summit, NJ

PREREQUISITES

Ph.D. and minimum of 3 years in relevant discipline with pharmaceutical experience.

Analytical Development

Analytical Development is a science-driven organization dedicated to building in-depth and comprehensive knowledge of our products and their processes through well-designed analytical studies. We work in all phases of pharmaceutical development to oversee the analytical processes for drug substance and drug product development both internally and with external contract service providers. Our goal is to enable the establishment of specifications and robust analytical procedures that allow control of our drug substance and drug product processes to provide safe, efficacious and high quality products to the patients we serve.

Responsibilities of a Scientist II will include, but are not limited to, the following:

The Scientist II 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 development. Support for drug candidates across all stages of development and, as needed, within our commercial product portfolio will be required.

The Scientist II individual should work with minimal supervision to carry out laboratory based de novo analytical method development, chemical characterization studies and chemical stability characterization evaluations. Where required, activities will be performed in accordance with cGLP/cGMP regulations, established business processes and protocols, and applicable standard operating procedures.
  • 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.
  • Generate/review laboratory clinical release and stability data.
  • Qualify/transfer analytical methodology to quality control and contract laboratories.
  • Provide leadership, teaching and mentoring to scientific staff.
  • 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:
  • PhD in Chemistry, Chemical Engineering, Material Science, Crystallography (or relevant discipline) with required years of experience
  • In-depth knowledge of small molecule form/salt characterization and selection techniques (such as vibrational spectroscopy, crystallography, SSNMR, vapor sorption, XRD, TGA, DSC, ...) and processes.
  • Hands-on and theorethical knowledge of crystal structure determination. This includes growing single crystal, data collection and structure solution.
  • Form characterization in drug product and drug product intermedates (such as SDD ...)
  • In-depth knowledge of vibrational spectroscopy and its application for form characterization is a strong plus.
  • Hands on experience with form screening and characterization is a plus.
  • Hands on experience with method development, validation and transfer is a plus.
  • Experience in participating and leading cross-functional teams. Knowledge and experience in linking API and excipient properties to drug product performance is a plus.
  • Hands-on experience with unknown material and/or foreign particulates identification is a plus
  • Understands and applies Quality by Design and DOE approaches when required


Expectations of the Scientist II 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, publication and presentation.
  • Direct impact on departmental performance.
  • Contributes to team goals (within and external to AD) and may participate in cross-functional project teams.
  • Knowledge of cGLP/cGMP and applicable FDA, EMA and ICH guidances.
  • Strong problem-solving and troubleshooting skills.
  • Strong capabilities in experimental design and execution.
  • Ability to work independently.
  • Ability to provide scientific guidance, leadership, and training to others within the department.


#LI-POST

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.