Senior Scientist II (Formulations)

Job Details:-

This is a job posting from company – Exelixis

Employment TypeFull Time

Work Hours: 8

Salary: $20 To $30/An Hour

Location: California, USA

This job is 100% remote.

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SUMMARY:

The Senior Scientist II will be responsible for early and late stage drug product development activities ranging from formulation, process development, optimization, and scale-up of small molecule oral dosage form. This individual will oversee and coordinate activities with contract manufacture organization CMOs, including technology transfer, scale-up, process validation, and commercialization. This individual must have a “take charge”, “lead by example” attitude, and excellent communication skills. The applicant also must possess a solid track record of dealing with external manufacturing, deep underlying technical problem-solving skills, and creative thinking in small molecule oral solid dosage forms. He/she will be working in a fast pace internal/external cross functional team environment, lead project teams, and prepares and reviews regulatory/Chemistry Manufacturing & Control (CMC) documents.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Oversee Exelixis drug product CMOs to manage every aspect of solid oral dosage form development studies and manufacturing of clinical trial material (CTM)

Lead and oversee clinical manufacture of Phase I, II and III supplies including detailed oversight of all pre-production, production and post-production operations.

Troubleshooting skill in formulation/process issues.

Lead technical discussion in deviation closure and CAPA resolution, in collaboration with quality team and external CMO.

Work as “person-in-plant” to oversee critical/milestone activities at CMOs as needed.

Closely liase and collaborate with the clinical supply team for forecasting and delivery of clinical batches. Communicate the production plan to the CMOs.

Apply methodical approach in selection of vehicles, excipients and/or new technologies appropriate to prepare formulations of novel investigational small molecules for in vivo studies.

Apply statistical design of experiments to optimize and scale-up formulations and manufacturing process.

Evaluate and develop enabling formulation such as but not limited to solid dispersion, lipid or microemulsion, liquid formulation.

Participation in project teams and internal/external collaborations, and preparation and review of regulatory/CMC documents.

Possess excellent writing and verbal communication skills and strong interpersonal skills.

SUPERVISORY RESPONSIBILITIES:

None

EDUCATION/EXPERIENCE/SKILLS:

Education:

BS/BA degree in pharmaceutics, or pharmaceutical sciences, bioengineering, biophysics, chemical engineering, and a minimum of nine years of related experience; or,

MS/MA degree in pharmaceutics, or pharmaceutical sciences, bioengineering, biophysics, chemical engineering, and a minimum of seven years of related experience; or,

PhD in pharmaceutics, or pharmaceutical sciences, bioengineering, biophysics, chemical engineering, and a minimum of two years of related experience; or,

Equivalent combination of education and experience.

Experience:

Experience in Pharmaceutical/Biotech industry preferred.

Must have proven skills in the areas of solid oral drug product formulation development

Hands on experience in fluid bed granulation, roller compaction, direct compression, aqueous and solvent-based coating is required.

Experience with statistical tools to design and evaluate experiments for formulation and process development preferred.

Experience with other dosage forms or advanced formulations (e.g. controlled release) is a plus.

Operation of various scientific instrumentation such as, High Performance Liquid Chromotography (HPLC), Fournier Transfer Infrared Spectroscopy (FTIR), Thermogravirmetric Analysis (TGA), and Differential Scanning Calorimeter (DSC), etc. is a plus.

Knowledge/Skills/Abilities:

Knowledge of formulation development and process optimzation/scale up of solid oral dosage forms.

Strong knowledge and experience of the various phases of drug development for oral dosage forms is required.

Ability to provide well organized formulation analysis results in a timely manner.

Ability to manage multiple project assignments and function in a driven and fast-moving team environment.

Familiarity and working knowledge of current Good Manufacturing Practices (cGMP)/International Conference on Harmonization (ICH) regulations, with experience working in a GMP facility is required.

Proficient with broad use of computer applications such as MS Office.

Applies strong analytical and excellent verbal and written communication skills.

Identifies and implements methods and procedures to achieve results.

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 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.

WORKING CONDITIONS:

  • Environment: Primarily working in office
  • Travel required – 15% of domestic/international travel required

If you like wild growth and working with happy, enthusiastic over-achievers, you’ll enjoy your career with us!

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.


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