9 days old
2018-06-112018-07-10

Temporary Research Scientist I (Analytical)

Exelixis, Inc.
South San Francisco, CA
  • Job Code
    1839
Position Description

Responsible for analytical related activities including method development/validation, method transfer and in-process support of the API manufacturing, drug product development and analytical method generation. Design and implement stability protocol and special studies in support of product development activities.
Position Requirements

ESSENTIAL DUTIES AND RESPONSIBILITIES:
Responsible for analytical related activities including method development/validation, method transfer and in-process support of the API manufacturing, drug product development and analytical method generation.
Design and implement ICH based stability protocols for various environmental zones.
Prepare analytical and stability reports and documents for regulatory submissions.
Manage CMO oversight during early pharmaceutical development. These may include:
Drug Substance and Drug Product method development
Drug Substance characterization such as: NMR, LC-MS, FTIR, XRPD, DSC, DVS, TGA, etc.
Drug Product method development such as excipient compatibility, formulation evaluation and dissolution.
Reference Standard development.
Evaluate physico-chemical characteristics of small molecules such as pH, pKa, solubility, pH-solubility profile, particle size, solid and solution state stability studies
Additional responsibilities include the operation and maintenance of various scientific instrumentation such as, High Performance Liquid Chromatography, Fournier Transfer Infrared Spectroscopy, Thermogravimetric Analysis, and Differential Scanning Calorimeter, etc.

SUPERVISORY RESPONSIBILITIES:
None

EDUCATION/EXPERIENCE/SKILLS:
Education:
BS/BA degree in related discipline and seven years of related experience; or,
MS/MA degree in related discipline and five years of related experience; or,
PhD in related discipline and two years of related experience, or;
Equivalent combination of education and experience.
May require certification in assigned area.

Experience:
Typically requires a minimum of ten years of related experience and/or combination of experience and education/training.
Experience in Biotech/Pharmaceutical industry preferred.
Must have proven skills in the areas of solid state characterization techniques, formulation experience in developing oral and IV formulation and unit operations involved in pharmaceutical processing
Participation in project related teams and other internal/external collaborations, and preparation and review of regulatory/CMC documents are also important aspects of this position.
Must be able to provide well organized formulation analysis results in a timely manner.
Experience with other dosage forms or advanced formulations (e.g. controlled release) is a plus.
Strong experience with solid-state characterization & analytical instrumentation.

Knowledge/Skills/Abilities:
Hands on experience in HPLC, dissolution and GC analysis.
Have strong knowledge in analytical chemistry and cGMP, FDA and ICH guidelines and regulations.
Familiarity with LC-MS technique is a plus.
Uses professional concepts and company objectives to resolve complex issues in creative and effective ways.
Performs a variety of complicated tasks with a wide degree of creativity and latitude.
Has complete understanding and wide application of technical principles, theories, concepts and techniques.
Has good general knowledge of other related disciplines.
Applies strong analytical and business communication skills.

JOB COMPLEXITY:
Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation of criteria for obtaining results.
Uses professional concepts and company's policies and procedures to solve a wide range of difficult problems in imaginative and practical ways.
Networks with key contacts outside own area of expertise.

DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

Exelixis is located in South San Francisco, CA and will be moving to Alameda, CA around June 2018.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.





Sponsored by:
Farm Credit Services of America Logo
Sponsored by:
Bank of America Logo

Featured Jobs[ View All ]

Featured Employers

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Temporary Research Scientist I (Analytical)

Exelixis, Inc.
South San Francisco, CA

Share this job

Temporary Research Scientist I (Analytical)

Exelixis, Inc.
South San Francisco, CA
US

Separate email addresses with commas

Enter valid email address for sender.

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast